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

A Pilot Randomized Controlled Trial (RCT) of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Dyadic Life Review

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Mitchell; Phone Number: 585-275-1192; Email: Lauren_Mitchell@URMC.rochester.edu
• Study Contact Backup: Name: Lee Kehoe; Phone Number: 1-315-567-3924; Email: lee_kehoe@URMC.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Lee Kehoe, PhD; Phone Number: (585) 276-7686; Email: Lee_Kehoe@URMC.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient Inclusion Criteria:

• Age ≥ 65
• Patient has a Stage III or IV advanced cancer diagnosis of any type
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dyadic Life Review; The Dyadic Life Review Arm (DLR) consists of 8 sessions delivered by a trained licensed clinician. Each session facilitates a recall of each phase of life. The patient and caregiver will each be asked structured questions to prompt reminiscence of memories from that phase of life. Interventionists are able to use clinical judgment to prompt further or ask follow-up questions or reflections. Additionally, the patient and caregiver will be asked to respond to the other dyad member's memory or reflection. Each session will have flexibility for clinical judgement.	Behavioral: Dyadic Life Review; DLR is an intervention that will promote relationship closeness, communication, and psychological distress in both older adults and caregivers.; Other Names: DLR
No Intervention: Case-As-Usual; The Care-As-Usual (CAU) arm will follow current practices for responding to patient distress. The CAU for patients involves a supportive follow-up phone call from the social work team to further assess the patient's experience of distress. In some instances, the social worker will use their clinical judgement to further refer the patient to community resources to support distress. The number of phone calls and any subsequent community referrals or appointments related to distress that occur will be tracked.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLR Intervention Enrollment Rate	Evaluate the feasibility of DLR in older patients and caregivers based on enrollment rate.	18 weeks
DLR Intervention Retention Rate	Evaluate the feasibility of DLR in older patients and caregivers based on retention rate.	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unidimensional Relationship Closeness Scale	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.	18 weeks
Communication Satisfaction Scale	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.	18 weeks
Distress Thermometer	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.	18 weeks

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Older Adults; Caregivers; Geriatric Oncology
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: UOCPC24051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No