NCT06505122

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
6mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
May 2025Oct 2026

First Submitted

Initial submission to the registry

July 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

May 23, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

July 10, 2024

Last Update Submit

March 18, 2026

Conditions

Cancer

Keywords

Older AdultsGeriatric OncologyCaregivers

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Unidimensional Relationship Closeness Scale

    18 weeks

  • Communication Satisfaction Scale

    18 weeks

  • Distress Thermometer

    18 weeks

Study Arms (2)

Dyadic Life Review

EXPERIMENTAL

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

Case-As-Usual

NO INTERVENTION

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.

Interventions

Dyadic Life ReviewBEHAVIORAL

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

Also known as: DLR
Dyadic Life Review

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to identify caregiver to participate in study
  • 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
  • Caregivers unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Lee Kehoe

CONTACT

1-315-567-3924lee_kehoe@URMC.rochester.edu

Lauren Mitchell

CONTACT

585-275-1192Lauren_Mitchell@URMC.rochester.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 17, 2024

Study Start

May 23, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)