Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04515810

Collaborator

National Cancer Institute (NCI) (NIH)

490

Enrollment

Locations

Arms

39.8

Anticipated Duration (Months)

122.5

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial tests a new mobile health application (app) called Planning Advance Care Together (PACT) to help people with cancer talk about and plan for advance care planning (the care they would want if they were unable to communicate) with their loved ones and doctors. The development of the PACT mobile app may help future patients incorporate their social network (typically, but not exclusively, family) into the advance care planning process.

Condition or Disease	Intervention/Treatment	Phase
Clinical Stage 0 Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Locally Advanced Gastroesophageal Junction Adenocarcinoma Locally Advanced Hepatocellular Carcinoma Locally Advanced Lung Carcinoma Locally Advanced Malignant Female Reproductive System Neoplasm Locally Advanced Pancreatobiliary Carcinoma Malignant Solid Neoplasm Metastatic Gastroesophageal Junction Adenocarcinoma Metastatic Hepatocellular Carcinoma Metastatic Lung Carcinoma Metastatic Malignant Female Reproductive System Neoplasm Metastatic Pancreatobiliary Carcinoma Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Refractory Gastroesophageal Junction Adenocarcinoma Refractory Hepatocellular Carcinoma Refractory Lung Carcinoma Refractory Malignant Female Reproductive System Neoplasm Refractory Pancreatobiliary Carcinoma Stage III Hepatocellular Carcinoma AJCC v8 Stage III Lung Cancer AJCC v8 Stage IIIA Hepatocellular Carcinoma AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Hepatocellular Carcinoma AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IVA Hepatocellular Carcinoma AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Hepatocellular Carcinoma AJCC v8 Stage IVB Lung Cancer AJCC v8	Other: Internet-Based Intervention Other: Best Practice Other: Questionnaire Administration	N/A

Detailed Description

OUTLINE: Patients and caregivers are randomized to 1 of 2 arms.

ARM I: Participants use PACT mHealth app.

ARM II: Participants engage in standard care with no modifications.

After completion of study intervention, participants are followed up at 3 and 6 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

490 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Planning Advance Care Together (PACT) to Improve Engagement in Advance Care Planning

Anticipated Study Start Date :

Sep 8, 2022

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (PACT) Participants use PACT mHealth app.	Other: Internet-Based Intervention Use smartphone application Other: Questionnaire Administration Ancillary studies
Active Comparator: Arm II (standard care) Participants engage in standard care with no modifications.	Other: Best Practice Engage in standard care Other Names: standard of care standard therapy Other: Questionnaire Administration Ancillary studies

Arm

Intervention/Treatment

Experimental: Arm I (PACT)

Participants use PACT mHealth app.

Other: Internet-Based Intervention

Use smartphone application

Other: Questionnaire Administration

Ancillary studies

Active Comparator: Arm II (standard care)

Participants engage in standard care with no modifications.

Other: Best Practice

Engage in standard care

Other Names:

standard of care

standard therapy

Other: Questionnaire Administration

Ancillary studies

Outcome Measures

Primary Outcome Measures

Change in level of engagement in advance care planning (patient) [Baseline, 3 months post-intervention, and 6 months post-intervention]
Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Change in level of engagement in advance care planning (caregiver) [Baseline, 3 months post-intervention, and 6 months post-intervention]
Caregivers will be assessed using an adapted caregiver version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Change in documentation of advance care planning conversations [Baseline, 3 months post-intervention, and 6 months post-intervention]
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (or patient) and doctor (or patient's doctor) (all yes/no questions).
Change in completion of advance directives [Baseline, 3 months post-intervention, and 6 months post-intervention]
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order(DNR), living will, or identified a Health Care Provider(HCP). All yes/no questions.
Change in user engagement as measured by number of views [Baseline, 3 months post-intervention, and 6 months post-intervention]
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
Change in user engagement as measured by time spent on app [Baseline, 3 months post-intervention, and 6 months post-intervention]
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.

Secondary Outcome Measures

Change in treatment preference [Baseline, 3 months post-intervention, and 6 months post-intervention]
This will be assessed in patients with an item used previously in our team's NCI-funded cohort studies that asks patients to express a preference for life-extending versus comfort care (two answer choices).
Change in healthcare utilization (summary score for total healthcare utilized) [Baseline, 3 months post-intervention, and 6 months post-intervention]
This measure will assess patients' receipt of life-prolonging care (number of emergency room visits, hospital admissions, length of stay in the hospital, rates of ICU admission) and use of palliative or hospice care (length and duration of palliative and/or hospice care). A total score will be created for healthcare utilization.
Change in number of subjects receiving goal-concordant care [Baseline, 3 months post-intervention, and 6 months post-intervention]
This will be determined by comparing patients' treatment preferences to treatment received. Patients matching on their desired and received care will be designated as having received goal-concordant care.
Change in perceived social support [Baseline, 3 months post-intervention, and 6 months post-intervention]
This will be assessed among patients and caregivers using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item valid and reliable measure of social support from family, friends, and significant other, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), with previously reported excellent internal reliability (Cronbach's α = 0.84 to 0.92).
Change in family functioning [Baseline, 3 months post-intervention, and 6 months post-intervention]
This will be assessed among patients and caregivers using the Family Relationship Index (FRI), a scale derived from the Family Environment Scale. FRI consists of 12 true/false items consisting of three subscales (cohesiveness, expressiveness, and conflict resolution) with scores ranging from 1 to 4 with higher scores indicating better family functioning. The FRI is well-validated in cancer patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

PATIENT: 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.
PATIENT: Access to a mobile device; the principal investigator (PI) will ensure that those who have access to a mobile device have access to a mobile device with internet access to ensure they can complete study procedures.
PATIENT: The ability to provide informed consent.
PATIENT: Identification of and enrollment a loved one/informal caregiver.
CAREGIVER: The person (family member or friend) whom the patient indicates being an informal caregiver.
CAREGIVER: English speaking.
CAREGIVER: 18 years of age or older.
CAREGIVER: Able to provide informed consent.
PROVIDER: Current clinical practice and/or research with advanced cancer patients.
PROVIDER: A history of 3+ years working with advanced cancer patients.
PROVIDER: 18 years of age or older. Providers across disciplines (e.g., social work, oncology) will be enrolled.

Exclusion Criteria:

PATIENT: Not fluent in English.
PATIENT: Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of >= 6 to be delivered by trained study research staff during screening).
PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer).
PATIENT: Currently receiving hospice at the time of enrollment.
PATIENT: Children and young adults under age 18.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwell Health	Manhasset	New York	United States	11030
2	Mount Sinai Hospital	New York	New York	United States	10029
3	NYP/Weill Cornell Medical Center	New York	New York	United States	10065
4	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington	United States	98109