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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07796347
Enrollment
120
Registered
2026-09-01
Start date
2026-10-01
Completion date
2030-07-28
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Older Adults, Geriatric Oncology, Caregivers

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.

Detailed description

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. This randomized controlled trial will enroll dyads and compare DLR to a waitlist control condition in which participants receive usual care and are offered DLR following completion of study procedures. In addition to examining the effects of DLR on caregiver burden, the study will explore whether DLR improves dyadic coping and relationship quality within the patient-caregiver relationship and identify patient and caregiver characteristics associated with greater intervention benefit. Findings from this study will provide preliminary evidence regarding the efficacy of DLR and inform future intervention development and implementation for older adults with cancer and cognitive impairment and their caregivers.

Interventions

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

Sponsors

University of Rochester
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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. Caregiver Inclusion Criteria: * 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 Patient

Exclusion criteria

* No caregiver willing to participate in the study Caregiver

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Stress Burden Score at Week 18Baseline and 18 weeksThe 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.
2. Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Demand Burden Score at Week 18Baseline and 18 weeksThe 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.
Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Objective Burden Score at Week 18Baseline and 18 weeksThe 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.

Secondary

MeasureTime frameDescription
Change From Baseline in Unidimensional Relationship Closeness Scale Score at Week 18Baseline and 18 weeksThe Unidimensional Relationship Closeness Scale is a 12 item self report measure assessing relationship closeness between the participant and family member. Each item is rated on a 7 point Likert scale. Total scores range from 12 to 84, with higher scores indicating greater relationship closeness.
Change From Baseline in Dyadic Adjustment Scale Score at Week 18Baseline and 18 weeksThe Dyadic Adjustment Scale is a 7 item self report measure assessing dyadic relationship quality and adjustment. Scores range from 0 to 36, with higher scores indicating greater relationship adjustment.

Countries

United States

Contacts

CONTACTLee Kehoe
Lee_Kehoe@URMC.rochester.edu585-275-4625
CONTACTJourdan Lubes
Jourdan_Lubes@URMC.rochester.edu585-275-1192

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026