N/A
Completed N=38
Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers
Cancer, Advanced · Cognitive Impairment, Mild
Source: ClinicalTrials.gov NCT05200572 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Proportion of Dyads That Complete the Study — 12 Dyads
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Dyads That Complete the Study |
12 | — |
| PRIMARY Proportion of Participants That Consent Who Are Approached for the Study |
38 | — |
| PRIMARY Number of Participants Who State the Intervention is Acceptable During a Qualitative Interview |
12 | — |
| SECONDARY Mean Change in the UCLA Loneliness Score for Caregivers |
0.64 | — |
| SECONDARY Mean Change in Unidimensional Relationship Closeness Scale for Caregivers |
-0.05 | — |
| SECONDARY Mean Change in Perceived Stress Scale for Caregivers |
-0.17 | — |
| SECONDARY Mean Change in Caregiver Reaction Scale for Caregivers |
-0.42 | — |
| SECONDARY Mean Change in Geriatric Depression Scale for Caregivers |
1.33 | — |
| SECONDARY Mean Change in Distress Thermometer and Problem List for Caregivers |
-0.42 | — |
| SECONDARY Mean Change in Dyadic Adjustment Scale-7 for Caregivers |
1.17 | — |
| SECONDARY Mean Change in Dyadic Support Questionnaire For Caregivers |
1.83 | — |
| SECONDARY Mean Change in the Correlation Between Patient and Caregiver Distress |
-0.64 | — |
| SECONDARY Mean Change in PROMIS29 Depression Domain For Caregivers |
-3.23 | — |
| SECONDARY Mean Change in PROMIS29 Anxiety Domain For Caregivers |
1.61 | — |
| SECONDARY Mean Change in PROMIS29 Physical Function Domain For Caregivers |
-0.56 | — |
| SECONDARY Mean Change in PROMIS29 Pain Interference Domain For Caregivers |
-2.45 | — |
| SECONDARY Mean Change in PROMIS29 Fatigue Domain For Caregivers |
-1.59 | — |
| SECONDARY Mean Change in PROMIS29 Sleep Disturbance Domain For Caregivers |
0.28 | — |
| SECONDARY Mean Change in PROMIS29 Ability to Participate in Social Roles Domain For Caregivers |
-0.57 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05200572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.