Patient-caregiver Communication Intervention for Prognostic Understanding

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03833817
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The purpose of this study is to: (1) develop a communication-based intervention to improve advanced cancer patients' and caregivers' prognostic understanding using communication strategies (e.g., acknowledgment, validation of fears) and distress management techniques (e.g., deep breathing, muscle relaxation); (2) evaluate the feasibility and acceptability of the intervention among advanced cancer patients and their caregivers; and (3) test the preliminary efficacy of the intervention on patients' and caregivers' prognostic understanding (primary outcome); completion of DNR order, living will, and health care proxy; psychological distress; communication quality; caregiver burden; and healthcare utilization (secondary outcomes).

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer	Behavioral: Talking about Cancer (TAC)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Communication-based Intervention for Advanced Cancer Patient-caregiver Dyads to Increase Engagement in Advance Care Planning and Reduce Caregiver Burden
• Actual Study Start Date: Sep 20, 2020
• Actual Primary Completion Date: Jun 17, 2021
• Actual Study Completion Date: Jan 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient intervention arm This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6).	Behavioral: Talking about Cancer (TAC); The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Experimental: Caregiver (of patient) intervention arm This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6).	Behavioral: Talking about Cancer (TAC); The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.

Outcome Measures

Primary Outcome Measures

1. Change in Prognostic Understanding [Baseline, post-intervention (within 30 days)]

   Change in prognostic understanding is assessed at baseline and post-intervention with two items on prognostic understanding: (1) Terminal illness acknowledgement with the item "How would you describe your current health status?" Answer choices include: 1) Relatively healthy, 2) relatively healthy but terminally ill, 3) seriously ill but not terminally ill, and 4) seriously ill and terminally ill, and (5) I don't know]. Responses 2 and 4 are coded as accurate and responses 1, 3, and 5 are coded as inaccurate. (2) Life-expectancy [Months, Years, and "I don't know"]. Months are coded as accurate and years and I don't know are coded as inaccurate. Each variable is coded as 0=inaccurate or 1=accurate, for a total summary score range of 0 to 2. Differences between baseline and post-intervention assessments are calculated (possible range, -2 to +2) to determine changes in prognostic understanding.

Secondary Outcome Measures

1. Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to Post-intervention [Baseline, post-intervention (within 30 days)]

   Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.

2. Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 3-month Follow-up [Baseline, follow-up (3 months)]

   Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.

3. Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to Post-intervention [Baseline, post-intervention (within 30 days)]

   Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.

4. Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 3-month Follow-up [Baseline, follow-up (3 months)]

   Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.

5. Change in Caregivers' Engagement in Advance Care Planning, as Measured by the Van Scoy and Sudore Measure Which Adapts the Decision Maker Subscale of the Advance Care Planning Engagement Survey, From Baseline to Post-Intervention [Baseline, post-intervention (within 30 days)]

   Change in caregiver engagement in advance care planning will be assessed with a companion measure in the final phases of validation by Van Scoy and Sudore. This measure adapts the Advance Care Planning Engagement Survey to apply to caregivers. Response options include: yes=1, no=0. Individual scores can range from 0 to 4, with higher scores indicating more decisions have been made. Change scores can range from -4 to +4.

6. Change in Caregivers' Engagement in Advance Care Planning, as Measured by the Van Scoy and Sudore Measure Which Adapts the Decision Maker Subscale of the Advance Care Planning Engagement Survey, From Baseline to 3-month Follow-up [Baseline, follow-up (3 months)]

   Change in caregiver engagement in advance care planning will be assessed with a companion measure in the final phases of validation by Van Scoy and Sudore. This measure adapts the Advance Care Planning Engagement Survey to apply to caregivers. Response options include: yes=1, no=0. Individual scores can range from 0 to 4, with higher scores indicating more decisions have been made. Change scores can range from -4 to +4.

7. Change in the Number of Advance Directives Completed [Baseline, post-intervention (within 30 days)]

   Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.

8. Change in Psychological Distress, as Measured by the Hospital Anxiety and Depression Scale (HADS) [Baseline, post-intervention (within 30 days)]

   Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress. Change in psychological distress will be assessed at baseline and post-intervention.

9. Change in Communication Quality, as Measured by the Family Communication Subscale of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) [Baseline, post-intervention (within 30 days)]

   Communication quality will be assessed with the 5-item Family Communication subscale of the Cancer Communication Assessment Tool for Patients and Families, a valid measure in cancer patients and caregivers. Response options are on a 5-point Likert-type scale (1 = strongly disagree to 5= strongly agree). Scores can range from 5 to 25, with higher scores indicating worse communication quality. Change in communication quality will be assessed at baseline and post-intervention.

10. Change in Caregiver Burden (Caregivers Only), as Measured by the Zarit Burden Interview [Baseline, post-intervention (within 30 days)]

    Caregiver burden will be assessed with the Zarit Burden Interview (ZBI), a reliable and valid 22-item measure of caregiver burden used in intervention studies of cancer caregivers. Response options are on a 5-point Likert-type scale (0 = never to 4=nearly always). Scores can range from 0 to 88, with higher scores indicating higher levels of burden. Change in caregiver burden will be assessed at baseline and post-intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Patient Inclusion Criteria:

• Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer (e.g., pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) and/or disease progression following at least first line chemotherapy.

• Ability to provide informed consent

• Identification of an informal caregiver

• Oncologist reported discussion of prognosis with the patient and/or caregiver.

Patient Exclusion Criteria:

• Not fluent in English

• Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6)

• Too ill or weak to complete the interviews (as judged by the interviewer)

• Currently receiving palliative care/hospice at the time of enrollment

• Children and young adults under age 18

• Deemed inappropriate for the study by their treating oncologist.

• In addition, patient-caregiver dyads in which both members have an accurate understanding of prognosis (terminal status and life-expectancy) will be excluded due to the lack of need for an intervention.

Caregiver inclusion criteria:

• The person (family member or friend) whom the patient indicates provides their informal (unpaid) care

• English speaking

• Able to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Megan J Shen, PhD, Fred Hutchinson Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 12, 2021

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03833817
• Other Study ID Numbers: 1803019107; R21CA224874
• First Posted: Feb 7, 2019
• Last Update Posted: Aug 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Weill Medical College of Cornell University: advance care planning; prognostic understanding; communication
• Additional relevant MeSH terms: Neoplasms

Study Results

Participant Flow

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Period Title: Overall Study
STARTED	14	14
COMPLETED	8	8
NOT COMPLETED	6	6

Baseline Characteristics

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm	Total
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	Total of all reporting groups
Overall Participants	14	14	28
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	59.36 (9.27)	57.07 (13.38)	58.21 (11.35)
Sex: Female, Male (Count of Participants)
Female	8 57.1%	7 50%	15 53.6%
Male	6 42.9%	6 42.9%	12 42.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	14 100%	14 100%	28 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 7.1%	1 3.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	13 92.9%	11 78.6%	24 85.7%
White	1 7.1%	2 14.3%	3 10.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	14 100%	14 100%	28 100%

Outcome Measures

1. Primary Outcome

Title	Change in Prognostic Understanding
Description	Change in prognostic understanding is assessed at baseline and post-intervention with two items on prognostic understanding: (1) Terminal illness acknowledgement with the item "How would you describe your current health status?" Answer choices include: 1) Relatively healthy, 2) relatively healthy but terminally ill, 3) seriously ill but not terminally ill, and 4) seriously ill and terminally ill, and (5) I don't know]. Responses 2 and 4 are coded as accurate and responses 1, 3, and 5 are coded as inaccurate. (2) Life-expectancy [Months, Years, and "I don't know"]. Months are coded as accurate and years and I don't know are coded as inaccurate. Each variable is coded as 0=inaccurate or 1=accurate, for a total summary score range of 0 to 2. Differences between baseline and post-intervention assessments are calculated (possible range, -2 to +2) to determine changes in prognostic understanding.
Time Frame	Baseline, post-intervention (within 30 days)

Outcome Measure Data

Analysis Population Description

The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up and did not have post-intervention data. The number of caregivers analyzed (n=8) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study and n=3 were lost to follow up and did not have post-intervention data.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	9	8
Mean (Standard Deviation) [Change in scores on a scale]	0.00 (0.50)	0.25 (0.46)

2. Secondary Outcome

Title	Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to Post-intervention
Description	Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Time Frame	Baseline, post-intervention (within 30 days)

Outcome Measure Data

Analysis Population Description

There are n=0 caregivers for this measure because this outcome variable was only assessed among patients. The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up and did not have post-intervention data.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	9	0
Mean (Standard Deviation) [Change in scores on a scale]	0.44 (1.24)

3. Secondary Outcome

Title	Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 3-month Follow-up
Description	Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Time Frame	Baseline, follow-up (3 months)

Outcome Measure Data

Analysis Population Description

There are n=0 caregivers for this measure because this outcome variable was only assessed among patients. The number of patients analyzed (n=7) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study, n=3 patients were lost to follow up and did not have post-intervention data, and n=1 patient did not provide data for this measure.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	7	0
Mean (Standard Deviation) [Change in scores on a scale]	1.14 (1.21)

4. Secondary Outcome

Title	Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to Post-intervention
Description	Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Time Frame	Baseline, post-intervention (within 30 days)

Outcome Measure Data

Analysis Population Description

There are n=0 caregivers for this measure because this outcome variable was only assessed among patients. The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up and did not have post-intervention data.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	9	0
Mean (Standard Deviation) [Change in scores on a scale]	0.78 (1.09)

5. Secondary Outcome

Title	Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 3-month Follow-up
Description	Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Time Frame	Baseline, follow-up (3 months)

Outcome Measure Data

Analysis Population Description

There are n=0 caregivers for this measure because this outcome variable was only assessed among patients. The number of patients analyzed (n=7) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study, n=3 patients were lost to follow up and did not have post-intervention data, and n=1 patient did not provide data for this measure.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	7	0
Mean (Standard Deviation) [Change in scores on a scale]	0.57 (0.96)

6. Secondary Outcome

Title	Change in Caregivers' Engagement in Advance Care Planning, as Measured by the Van Scoy and Sudore Measure Which Adapts the Decision Maker Subscale of the Advance Care Planning Engagement Survey, From Baseline to Post-Intervention
Description	Change in caregiver engagement in advance care planning will be assessed with a companion measure in the final phases of validation by Van Scoy and Sudore. This measure adapts the Advance Care Planning Engagement Survey to apply to caregivers. Response options include: yes=1, no=0. Individual scores can range from 0 to 4, with higher scores indicating more decisions have been made. Change scores can range from -4 to +4.
Time Frame	Baseline, post-intervention (within 30 days)

Outcome Measure Data

Analysis Population Description

There are n=0 patients for this measure because this outcome variable was only assessed among caregivers. The number of caregivers analyzed (n=8) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study and n=3 were lost to follow up and did not have post-intervention data.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	0	8
Mean (Standard Deviation) [Change in scores on a scale]	-0.50 (0.93)

7. Secondary Outcome

Title	Change in Caregivers' Engagement in Advance Care Planning, as Measured by the Van Scoy and Sudore Measure Which Adapts the Decision Maker Subscale of the Advance Care Planning Engagement Survey, From Baseline to 3-month Follow-up
Description	Change in caregiver engagement in advance care planning will be assessed with a companion measure in the final phases of validation by Van Scoy and Sudore. This measure adapts the Advance Care Planning Engagement Survey to apply to caregivers. Response options include: yes=1, no=0. Individual scores can range from 0 to 4, with higher scores indicating more decisions have been made. Change scores can range from -4 to +4.
Time Frame	Baseline, follow-up (3 months)

Outcome Measure Data

Analysis Population Description

There are n=0 patients for this measure because this outcome variable was only assessed among caregivers. The number of caregivers analyzed (n=7) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study, n=3 were lost to follow up and did not have post-intervention data, and n=1 did not provide data for this outcome.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	0	7
Mean (Standard Deviation) [Change in scores on a scale]	.14 (1.57)

8. Secondary Outcome

Title	Change in the Number of Advance Directives Completed
Description	Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.
Time Frame	Baseline, post-intervention (within 30 days)

Outcome Measure Data

Analysis Population Description

There are n=0 caregivers for this measure because this outcome variable was only assessed among patients. The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up and did not have post-intervention data.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	9	0
Mean (Standard Deviation) [Change in completed advance directives]	0.56 (1.01)

9. Secondary Outcome

Title	Change in Psychological Distress, as Measured by the Hospital Anxiety and Depression Scale (HADS)
Description	Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress. Change in psychological distress will be assessed at baseline and post-intervention.
Time Frame	Baseline, post-intervention (within 30 days)

Outcome Measure Data

Analysis Population Description

The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up and did not have post-intervention data. The number of caregivers analyzed (n=8) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study and n=3 were lost to follow up and did not have post-intervention data.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	9	8
Mean (Standard Deviation) [Change in scores on a scale]	0.33 (6.54)	-2.12 (5.79)

10. Secondary Outcome

Title	Change in Communication Quality, as Measured by the Family Communication Subscale of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF)
Description	Communication quality will be assessed with the 5-item Family Communication subscale of the Cancer Communication Assessment Tool for Patients and Families, a valid measure in cancer patients and caregivers. Response options are on a 5-point Likert-type scale (1 = strongly disagree to 5= strongly agree). Scores can range from 5 to 25, with higher scores indicating worse communication quality. Change in communication quality will be assessed at baseline and post-intervention.
Time Frame	Baseline, post-intervention (within 30 days)

Outcome Measure Data

Analysis Population Description

The original CCAT scale is scored on a scale from 1 to 6, but this data had a 1 to 5 response scale. The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up. The number of caregivers analyzed (n=8) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study and n=3 were lost to follow up.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	9	8
Mean (Standard Deviation) [Change in scores on a scale]	-1.33 (6.63)	0.50 (2.00)

11. Secondary Outcome

Title	Change in Caregiver Burden (Caregivers Only), as Measured by the Zarit Burden Interview
Description	Caregiver burden will be assessed with the Zarit Burden Interview (ZBI), a reliable and valid 22-item measure of caregiver burden used in intervention studies of cancer caregivers. Response options are on a 5-point Likert-type scale (0 = never to 4=nearly always). Scores can range from 0 to 88, with higher scores indicating higher levels of burden. Change in caregiver burden will be assessed at baseline and post-intervention.
Time Frame	Baseline, post-intervention (within 30 days)

Outcome Measure Data

Analysis Population Description

There are n=0 patients for this measure because this outcome variable was only assessed among caregivers. The number of caregivers analyzed (n=8) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study and n=3 were lost to follow up and did not have post-intervention data.

Arm/Group Title	Patient Intervention Arm	Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.	This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
Measure Participants	0	8
Mean (Standard Deviation) [Change in scores on a scale]	-4.13 (9.00)

Adverse Events

Time Frame	3 months (during study period)
Arm/Group Title	Patient Intervention Arm		Caregiver (of Patient) Intervention Arm
Arm/Group Description	This intervention arm contains the patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.		This intervention arm contains the caregivers of patients from this single arm study in which patients and caregivers will be given the experimental intervention (TAC intervention) with assessments pre and post intervention. The intervention will consist of six 45-minute telephone-delivered sessions. Session topics will include: (a) Distress management/tolerance (Sessions 1 and 2); (b) communication skills (Sessions 3 and 4); (c) guided review of prognostic information (Session 5); and (d) Intervention review and future plan (Session 6). Sessions will be completed by the individual (Sessions 1 and 3) and dyad (Sessions 2, and 4-6). Talking about Cancer (TAC): The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
All Cause Mortality
	Patient Intervention Arm		Caregiver (of Patient) Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/14 (7.1%)		0/14 (0%)
Serious Adverse Events
	Patient Intervention Arm		Caregiver (of Patient) Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Patient Intervention Arm		Caregiver (of Patient) Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)

Limitations/Caveats

The statistical analysis plan (and associated statistical power) was based on an expected sample size of 30 evaluable dyads. Due to COVID-19 and restrictions around data collection, only 14 dyads were consented and 8 dyads were evaluable (with n=9 patients, n=8 caregivers). This reduced sample size was not sufficient for the statistical analysis plan as written, and, therefore, only descriptive statistics for the response proportions can be presented for the study.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.