Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Alzheimer's Disease and Related Dementias and Their Caregivers
A Randomized Controlled Trial (RCT) of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Alzheimer's Disease and Related Dementias (ADRD) and Their Caregivers
2 other identifiers
interventional
120
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Oct 2026
Longer than P75 for not_applicable cancer
1 active site
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
CompletedFirst Posted
Study publicly available on registry
September 1, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 28, 2030
September 1, 2026
August 1, 2026
3.4 years
August 27, 2026
August 27, 2026
Conditions
Keywords
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
EXPERIMENTALThe 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.
Care-As-Usual
NO INTERVENTIONThe 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.
Eligibility Criteria
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
- University of Rochesterlead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
MeSH Terms
Conditions
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