Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers (DLR Pilot)

Feasibility of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Mild Cognitive Impairment (MCI) and Their Caregivers

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).

Study Overview

• Status: Completed
• Conditions: Cancer, Advanced; Cognitive Impairment, Mild
• Intervention / Treatment: Behavioral: Dyadic Life Review (DLR)

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Patient Inclusion Criteria:

• 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

Patient Exclusion Criteria:

• Patients scoring <14.5 on the UBACC
• Unable to identify caregiver to participate in study

Caregiver Inclusion Criteria:

• 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

Caregiver Exclusion Criteria

• Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Total subjects; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in the UCLA Loneliness Score for Caregivers	UCLA Loneliness Scale assesses perceived loneliness on a 0-10 scale, with higher scores indicating greater loneliness. Mean change was calculated as week 14 score minus baseline score for caregivers who completed the measure.	baseline to week 14
Mean Change in Unidimensional Relationship Closeness Scale for Caregivers	This measures the quality of the relationship with the care-receiver: assesses quality of relationship between participant and family member and has demonstrated valid scores across several relationship types, including spouses and other family members. The scale of this instrument ranges from 1 to 7 with higher scores indicating more closeness. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.	baseline to week 14
Mean Change in Perceived Stress Scale for Caregivers	Measures perceived stress, scale 0-40, higher scores indicate greater stress. Mean change calculated as week 14 minus baseline for caregivers who completed the measure.	baseline to week 14
Mean Change in Caregiver Reaction Scale for Caregivers	Items assess both positive and negative aspects of caregiving. Subscales: role captivity, overload, relational deprivation, competence, personal gain, family beliefs, family conflict, job conflict. The scale ranges from 0 to 24 with higher scores indicating a more negative caregiver experience. Preliminary evidence for the validity and reliability of the Caregiver Reaction Scale. Mean change calculated as week 14 minus baseline for caregivers who completed the measure.	baseline to week 14
Mean Change in Geriatric Depression Scale for Caregivers	The purpose of this scale is to identify the clinical threshold of depression in older adults. The scale ranges from 0 to 15 with higher scores indicating worse depression. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated. Mean change calculated as week 14 minus baseline for caregivers who completed the measure.	baseline to week 14
Mean Change in Distress Thermometer and Problem List for Caregivers	This tool is a 10-point self-report measure to capture distress and identify a list of sources of that distress. The scale ranges from 0-10 with higher scores indicating more distress. Mean change calculated as week 14 minus baseline for caregivers who completed the measure.	baseline to week 14
Mean Change in Dyadic Adjustment Scale-7 for Caregivers	This is a 7-item measure to assess relationship quality that ranges from 0-36 with higher scores indicating positive relationship quality. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.	baseline to week 14
Mean Change in Dyadic Support Questionnaire For Caregivers	18-item measure assessing perceived received and provided support. Scale 0-145, higher scores indicate better dyadic coping. Mean change calculated as week 14 minus baseline for caregivers who completed the measure.	baseline to week 14
Mean Change in the Correlation Between Patient and Caregiver Distress	Distress measured using Distress Thermometer (0-10, higher = more distress). Pearson correlation coefficient between patient and caregiver distress scores calculated at baseline and week 14; mean change = week 14 minus baseline.	baseline to week 14
Mean Change in PROMIS29 Depression Domain For Caregivers	Patient-Reported Outcomes Measurement Information System 29-item profile (PROMIS29) - Depression Domain. Scores range from 0-10, with higher scores indicating worse depression. Mean change was calculated as week 14 minus baseline. Mean change calculated as week 14 minus baseline for caregivers who completed both assessments.	baseline to week 14
Mean Change in PROMIS29 Anxiety Domain For Caregivers	PROMIS29 - Anxiety Domain. Scores range from 0-10, with higher scores indicating worse anxiety. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.	baseline to week 14
Mean Change in PROMIS29 Physical Function Domain For Caregivers	PROMIS29 - Physical Function Domain. Scores range from 0-10, with higher scores indicating worse physical function. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.	baseline to week 14
Mean Change in PROMIS29 Pain Interference Domain For Caregivers	PROMIS29 - Pain Interference Domain. Scores range from 0-10, with higher scores indicating more pain interference. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.	baseline to week 14
Mean Change in PROMIS29 Fatigue Domain For Caregivers	PROMIS29 - Fatigue Domain. Scores range from 0-10, with higher scores indicating worse fatigue. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.	baseline to week 14
Mean Change in PROMIS29 Sleep Disturbance Domain For Caregivers	PROMIS29 - Sleep Disturbance Domain. Scores range from 0-10, with higher scores indicating worse sleep disturbance. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.	baseline to week 14
Mean Change in PROMIS29 Ability to Participate in Social Roles Domain For Caregivers	PROMIS29 - Ability to Participate in Social Roles Domain. Scores range from 0-10, with higher scores indicating worse social role participation. Mean change calculated as week 14 minus baseline. The change in score pre and post intervention was determined by subtracting the post intervention score from the pre intervention score and the mean of the change scores was calculated.	baseline to week 14

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI); National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Neoplasms; Cognitive Dysfunction
• Other Study ID Numbers: STUDY00006662; P30AG064103 (U.S. NIH Grant/Contract); T32CA102618 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No