Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers

NCT05200572 | Completed Results DMC

• 3 other identifiers: STUDY00006662T32CA102618P30AG064103
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the feasibility of a telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy, with patients and caregivers of older adults with advanced cancer, including those with also Mild Cognitive Impairment (MCI). The study will enroll aim to enroll 20 dyads (pairs) of patients and caregivers (40 total subjects).

Conditions

Cancer, Advanced; Cognitive Impairment, Mild

Outcome Measures

Primary Outcomes (3)

• Proportion of Dyads That Complete the Study

  The number of participants that complete the entire study procedures out of the number of participants enrolled in the study. The study consisted of one patient and one caregiver (defined as a dyad) that completed the study procedures together), therefore there were 19 dyads enrolled in the study or 38 participants. The proportion of participants that completed the study was determined out of the 19 dyads enrolled.

  week 14

• Proportion of Participants That Consent Who Are Approached for the Study

  The number of participants who consented for the study out of the number of eligible participants who were approached and asked if they would like to be in the study. This outcome measures the proportion of potential participants approached who provided informed consent to participate in the Dyadic Life Review (DLR) study. A total of 42 patients were approached, and 38 provided informed consent to participate.The proportion was calculated as the number who consented divided by the total number approached (38 ÷ 42 × 100 = 90.5 percent).

  Baseline

• Number of Participants Who State the Intervention is Acceptable During a Qualitative Interview

  The proportion of participants who completed the full study intervention and indicated that the intervention was acceptable during post-intervention qualitative interviews. Acceptability was assessed only among participants who completed all study sessions.

  week 14

Secondary Outcomes (16)

• Mean Change in the UCLA Loneliness Score for Caregivers

  baseline to week 14

• Mean Change in Unidimensional Relationship Closeness Scale for Caregivers

  baseline to week 14

• Mean Change in Perceived Stress Scale for Caregivers

  baseline to week 14

• Mean Change in Caregiver Reaction Scale for Caregivers

  baseline to week 14

• Mean Change in Geriatric Depression Scale for Caregivers

  baseline to week 14

Study Arms (1)

Total subjects

EXPERIMENTAL

We will enroll dyads (defined as a pair of two people). The dyads are made up of a patient with cancer and their caregiver. The patient and caregiver dyad will go through the Dyadic Life Review intervention together. Dyadic Life Review will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes. Both patients and caregivers will each complete their own measures before and after completing the Dyadic Life Review intervention.

Behavioral: Dyadic Life Review (DLR)

Interventions

Dyadic Life Review (DLR) BEHAVIORAL

DLR will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes. Each session will facilitate a recall of each phase of life: childhood, adolescence, young adulthood, mid-life, earlier later life, and later life. While together, the patient and caregiver will each be asked structured questions to prompt reminiscence of memories from that phase of life.

Total subjects

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 65
• Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 56 - a score \>14.5 will define ability to independently provide informed consent.
• Eligible patients have Stage III or IV cancer of any type
• Additionally, at least 20 patients will have a will have a high likelihood of MCI based on screening score of \<26 on the Montreal Cognitive Assessment (MoCA) within their eRecord chart.
• Able to read and understand English

You may not qualify if:

• Patients scoring \<14.5 on the UBACC
• Unable to identify caregiver to participate in study
• One caregiver for each patient will be eligible and must be chosen by the patient. For the purposes of this study, a caregiver is defined as a valued and trusted person in a patient's life who is supportive in health care matters by providing valuable social support and/or direct assistive care.
• Caregivers will be selected by the patient when asked if there is a "family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") will remain eligible for the study.
• Age 50 or older
• Ability to provide consent
• Proficient in English
• Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Lee Kehoe, Ph.D.
• Organization: University of Rochester

leekehoephd@gmail.com

(585) 276-7686

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: March 28, 2022
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)