NCT05200572: DLR Pilot

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

Completed NA Results posted Last updated 25 November 2025

What this trial tests

NA trial testing Dyadic Life Review (DLR) in Cancer, Advanced in 38 participants. Completed in 24 May 2024.

Timeline

28 March 2022

Primary endpoint
24 May 2024

24 May 2024

Quick facts

Lead sponsor	University of Rochester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	38
Start date	28 March 2022
Primary completion	24 May 2024
Estimated completion	24 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Dyadic Life Review (DLR)

Conditions studied

• Cancer, Advanced — all drugs for Cancer, Advanced →
• Cognitive Impairment, Mild — all drugs for Cognitive Impairment, Mild →

Sponsor

University of Rochester

Who can join

50 and older, any sex, with Cancer, Advanced or Cognitive Impairment, Mild. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Dyads That Complete the Study Primary · week 14

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.

Group	Value	95% CI
Cancer Patients	12

Proportion of Participants That Consent Who Are Approached for the Study Primary · Baseline

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).

Group	Value	95% CI
DLR Intervention	38

Number of Participants Who State the Intervention is Acceptable During a Qualitative Interview Primary · week 14

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.

Group	Value	95% CI
DLR Intervention	12

Mean Change in the UCLA Loneliness Score for Caregivers Secondary · baseline to week 14

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.

Group	Value	95% CI
DLR Intervention	0.64	± 4.97

Mean Change in Unidimensional Relationship Closeness Scale for Caregivers Secondary · baseline to week 14

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.

Group	Value	95% CI
DLR Intervention	-0.05	± 0.7

Mean Change in Perceived Stress Scale for Caregivers Secondary · baseline to week 14

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.

Group	Value	95% CI
DLR Intervention	-0.17	± 2.08

Mean Change in Caregiver Reaction Scale for Caregivers Secondary · baseline to week 14

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.

Group	Value	95% CI
DLR Intervention	-0.42	± 2.07

Mean Change in Geriatric Depression Scale for Caregivers Secondary · baseline to week 14

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.

Group	Value	95% CI
DLR Intervention	1.33	± 2.53

Mean Change in Distress Thermometer and Problem List for Caregivers Secondary · baseline to week 14

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.

Group	Value	95% CI
DLR Intervention	-0.42	± 2.43

Mean Change in Dyadic Adjustment Scale-7 for Caregivers Secondary · baseline to week 14

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.

Group	Value	95% CI
DLR Intervention	1.17	± 3.93

Mean Change in Dyadic Support Questionnaire For Caregivers Secondary · baseline to week 14

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.

Group	Value	95% CI
DLR Intervention	1.83	± 6.56

Mean Change in the Correlation Between Patient and Caregiver Distress Secondary · baseline to week 14

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.

Group	Value	95% CI
DLR Intervention	-0.64	± 0.05

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.