Cancer and Mild Cognitive Impairment Dyadic Intervention

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05144516
Collaborator
(none)
144
1
1
60
2.4

Study Details

Study Description

Brief Summary

The purpose of this study is to see whether programs that include both a patient and their spouse or a patient and family caregiver (known as a dyad) are helpful for families in which one member of the dyad has cancer and mild memory difficulties and/or concerns. Participant and their spouse or participant and their family caregiver will have six, 60-minute video-conference sessions which will be scheduled at their convenience. The investigator will loan participants a tablet computer (iPad) to use for videoconferencing and train the participant in its use. Participant and their spouse or participant and their family caregiver will complete three assessments - one before starting the sessions, one after the sixth session, and one after 1 month. Each assessment will include surveys, which the participant will complete separately from their spouse or family caregiver. For most people, it will take upwards of 2 - 4 months to complete this study

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral: COPE +
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment-2
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2027
Anticipated Study Completion Date :
Sep 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient Caregiver Dyad

Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver.

Behavioral: Behavioral: COPE +
Six sixty minute sessions that teaches participants distress and communication coping skills.

Outcome Measures

Primary Outcome Measures

  1. Number of completed sessions as measured by enrollment log [Up to 10 Weeks]

  2. Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8 [Up to 10 weeks]

    The Client Satisfaction Questionnaire (CSQ-8) is a self report measure of satisfaction with health and behavioral services received. The CSQ-8 is measured on a four point Likert scale from 1 "Quite Dissatisfied" to 4 "Very Satisfied." Scores range from 8-32, with higher values indicating higher satisfaction

Secondary Outcome Measures

  1. Change in Distress as measured by the DASS-21 [Baseline, up to 10 weeks]

    The Depression, Anxiety, and Stress Scale (DASS-21) measure will be used for rating general distress across three emotional states of depression, anxiety, and stress. The measure has a total of 21 items. Scores range from 0- 63, with higher scores indicating greater distress.

  2. Change in Quality of Life as measured by the FACT-G [Baseline, up to 10 weeks]

    The Functional Assessment of Cancer Therapy: General (FACT-G) measure will be used for rating quality of life. The measure has a total of 27 items. Scores range from 0-108, with higher scores indicating greater quality of life.

  3. Change in Communication Patterns as measured by the CPQ-SF [Baseline, up to 10 weeks]

    The Communication Patterns Questionnaire Short-Form (CPQ-SF) will be used for rating communication patterns in a relationship. The measure has a total of 11 items. Scores range from 11-99, higher scores indicate a greater likelihood of using a particular communication pattern during conflict interactions.

  4. Change in Relationship Satisfaction as measured by the Mutuality Scale of the Family Care Inventory [Baseline, up to 10 weeks]

    The Mutuality Scale of the Family Care Inventory will be used for rating mutual concerns and overall relationship satisfaction. The measure consists of 15 items. Scores range from 0-60, higher scores indicate greater relationship satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Patient inclusion criteria include:
  1. Patients with Stage I-IV breast, colon, rectal, or lung cancer (newly diagnosed within 6 months); age 65 or older.

  2. Participants must be living at home (either in her/his own home).

  3. Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.

  4. Exhibit Mild Cognitive Impairment/Concerns

  5. Have an informal family caregiver.

Inclusion Criteria:

(Partner or family member) inclusion criteria include:

  1. Caregivers are 18 older.

  2. Be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.

  3. Either co-reside with the patient or spend at least 3-4 hours day caregiving.

  4. Not exhibit cognitive impairment.

Exclusion Criteria:
  1. Participant has visual or hearing impairments that preclude participation.

  2. Participant has dementia and do not have the capacity to participate.

  3. Have a serious untreated psychiatric illness as documented in medical chart review.

  4. The patient and the caregiver score less than a 3 on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) on a scale 0 to 10 to screen for distress.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Katherine Ramos, Ph.D., Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05144516
Other Study ID Numbers:
  • Pro00109148
First Posted:
Dec 3, 2021
Last Update Posted:
May 24, 2022
Last Verified:
Oct 1, 2021
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 Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022