Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Alzheimer's Disease and Related Dementias and Their Caregivers

NCT07796347 — Not applicable, Not yet recruiting, 120 participants, University of Rochester

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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

RegistryNCT07796347
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment120 (Estimated)
SponsorUniversity of Rochester (Other); collaborators: National Institute on Aging (NIA)
ConditionsCancer
InterventionsDyadic Life Review (Behavioral)
Datesstart 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
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Cancer All trials of Dyadic Life Review

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Dyadic Life ReviewExperimentalBehavioral: Dyadic Life ReviewThe 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-UsualNo 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.
  • Dyadic Life Review (Behavioral): DLR is an intervention that will promote relationship closeness, communication, and psychological distress in both older adults and caregivers.

+Outcome measures

Primary outcomes

  • Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Stress Burden Score at Week 18 [Baseline and 18 weeks]: 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.
  • 2. Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Subjective Demand Burden Score at Week 18 [Baseline and 18 weeks]: 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.
  • Change From Baseline in Montgomery Borgatta Caregiver Burden Scale Objective Burden Score at Week 18 [Baseline and 18 weeks]: 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.

Secondary outcomes

  • Change From Baseline in Unidimensional Relationship Closeness Scale Score at Week 18 [Baseline and 18 weeks]: The 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 18 [Baseline and 18 weeks]: The 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.

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
University of RochesterRochester, New YorkUnited States

+Funding

NIH grants: K23AG086622