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

University of Rochester

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: Dyadic Life Review

Study type: Interventional

Funder types: Other

Identifiers

NCT06505122

UOCPC24051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Dyadic Life Review

Experimental group

Description:

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.

Treatment:

Behavioral: Dyadic Life Review

Case-As-Usual

No Intervention group

Description:

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.