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NCT Number: NCT07796347

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

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Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dyadic Life Review

Behavioral

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

Primary outcomes

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

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

    Time frame: 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.

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

    Time frame: 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

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

    Time frame: 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.

  2. Change From Baseline in Dyadic Adjustment Scale Score at Week 18

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jourdan Lubes

CONTACT

[email protected]

585-275-1192

Lee Kehoe

CONTACT

[email protected]

585-275-4625

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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