NCT07796347

Brief Summary

The purpose of this study is to evaluate the efficacy of Dyadic Life Review (DLR) therapy for reducing caregiver distress, measured by caregiver burden to capture the multifaceted experience of distress, among older adults with advanced cancer and cognitive impairment and their caregivers.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
47mo left

Started Oct 2026

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2030

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2030

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

3.4 years

First QC Date

August 27, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

Older AdultsGeriatric OncologyCaregivers

Outcome Measures

Primary Outcomes (3)

  • Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Stress Burden Score at Week 18

    The subjective stress burden domain of the Montgomery Borgatta Caregiver Burden Scale assesses stress experienced by the caregiver in relation to caregiving. Scores range from 4 to 20, with higher scores indicating greater burden.

    Baseline and 18 weeks

  • 2. Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Demand Burden Score at Week 18

    The subjective demand burden domain of the Montgomery Borgatta Caregiver Burden Scale assesses the caregiver's perceived demands associated with caregiving. Scores range from 4 to 20, with higher scores indicating greater burden.

    Baseline and 18 weeks

  • Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Objective Burden Score at Week 18

    The Montgomery Borgatta Caregiver Burden Scale is a 14 item self report measure of caregiver burden. The objective burden domain assesses the impact of caregiving activities on the caregiver. Scores range from 0 to 30, with higher scores indicating greater burden.

    Baseline and 18 weeks

Secondary Outcomes (2)

  • Change From Baseline in Unidimensional Relationship Closeness Scale Score at Week 18

    Baseline and 18 weeks

  • Change From Baseline in Dyadic Adjustment Scale Score at Week 18

    Baseline and 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

Care-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

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

Dyadic Life Review

Eligibility Criteria

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

You may qualify if:

  • Age ≥65
  • Stage III or IV cancer diagnosis, of any type
  • The Montreal Cognitive Assessment (MoCA) in-person or MoCA-telephone version ≥15
  • Katz Activities of Daily Living (ADL) ≥5
  • Able to read and understand English
  • Be able to provide informed consent (as measured by UBACC) or have a Legally Authorized Representative to provide informed consent, which can include the participating caregiver.
  • Age 50 or older
  • Caregivers are defined is a "significant other, spouse, romantic partner, or adult child with whom you discuss or who can be helpful in health-related matters;"
  • Modified Caregiver Strain Index ≥ 5
  • Able to read and understand English

You may not qualify if:

  • No caregiver willing to participate in the study
  • 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

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

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
Assistant Professor - Department of Psychiatry, Research

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 28, 2030

Study Completion (Estimated)

July 28, 2030

Last Updated

September 1, 2026

Record last verified: 2026-08

Locations