Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers

Not Applicable

Recruiting

• Conditions: Cancer

• Registration Number: NCT06505122
• Lead Sponsor: University of Rochester

Brief Summary

The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work.

Detailed Description

The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work. The study will enroll dyads (pairs) of caregivers and older patients with advanced cancer and dyads of caregivers and patients with advanced cancer. A previous single-arm study was performed testing the feasibility of the adapted DLR intervention in older adults with advanced cancer and their caregivers. The single-arm pilot demonstrated DLR was feasible and acceptable by both patients and caregivers. This innovative pilot study will gather data to test the feasibility of a pilot and examine pre-post intervention changes in caregiver psychological distress.

Study Timeline

• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-17
• Study Start: 2025-05-23
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-29
• Last Update Posted: 2025-08-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥ 65
• Within 180 days of Stage III or IV advanced cancer diagnosis, any type of cancer
• Score of 4 or more on National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT)*
• Able to read and understand English

Patient

Exclusion Criteria

• Unable to identify caregiver to participate in study

Caregiver Inclusion Criteria:

• One caregiver must enroll with each patient for either subject to be eligible.
• Caregivers will be selected by the patient when asked if there is a "significant other, spouse, romantic partner, or adult child with whom you discuss or can be helpful in health-related matters;"
• Age 50 or older
• Able to reach and understand English

Caregiver Exclusion Criteria:

• Caregivers unable to provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
DLR Intervention Retention Rate	18 weeks	Evaluate the feasibility of DLR in older patients and caregivers based on retention rate.
DLR Intervention Enrollment Rate	18 weeks	Evaluate the feasibility of DLR in older patients and caregivers based on enrollment rate.

Secondary Outcome Measures

Name	Time	Method
Unidimensional Relationship Closeness Scale	18 weeks	Quality of relationship with care-receiver: assesses quality of relationship between participant and family member and has demonstrated valid scores across several relationship types, including spouses and other family members. This is a 12-item scale, rated from 1-7 (1=strongly agree, 7=strongly disagree), with a possible total of 84; a higher score indicates a higher level of closeness.
Distress Thermometer	18 weeks	A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress.
Communication Satisfaction Scale	18 weeks	The observation of each partner's level of satisfaction with various aspects of their communication. This is a 12-item scale, rated from 1-5 (1=not at all satisfied, 5=extremely satisfied), with a possible total of 60; a higher score indicates greater satisfaction with communication.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States