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

NCT ID: NCT06505122

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-23

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Cancer

Keywords

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Older Adults Geriatric Oncology Caregivers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dyadic Life Review

Intervention Type BEHAVIORAL

DLR is an intervention that will promote relationship closeness, communication, and psychological distress in both older adults and caregivers.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dyadic Life Review

DLR is an intervention that will promote relationship closeness, communication, and psychological distress in both older adults and caregivers.

Intervention Type BEHAVIORAL

Other Intervention Names

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DLR

Eligibility Criteria

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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


* 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

Exclusion Criteria

• Unable to identify caregiver to participate in study


• Caregivers unable to provide consent
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Lee Kehoe

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lee Kehoe

Role: CONTACT

Phone: 1-315-567-3924

Email: [email protected]

Lauren Mitchell

Role: CONTACT

Phone: 585-275-1192

Email: [email protected]

Facility Contacts

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Lee Kehoe, PhD

Role: primary

Other Identifiers

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UOCPC24051

Identifier Type: -

Identifier Source: org_study_id