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
| Registry | NCT07796347 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 120 (Estimated) |
| Sponsor | University of Rochester (Other); collaborators: National Institute on Aging (NIA) |
| Conditions | Cancer |
| Interventions | Dyadic Life Review (Behavioral) |
| Dates | start 2026-10-01 (estimated), primary completion 2030-02-28 (estimated), completion 2030-07-28 (estimated), first posted 2026-09-01, last updated 2026-09-01 |
| Locations | 1 site in United States |
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All trials for Cancer All trials of Dyadic Life Review
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dyadic Life Review | Experimental | Behavioral: 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. |
| 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. |
Sex: All, ages: 50 Years to any
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 Exclusion Criteria: • Caregivers unable to provide consent
| Facility | City | Country | Status |
|---|---|---|---|
| University of Rochester | Rochester, New York | United States |
NIH grants: K23AG086622