Dyadic Life Review for older adults with advanced cancer and their caregivers
A Pilot Randomized Controlled Trial (RCT) of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers
This pilot will try a structured Dyadic Life Review program to see if it helps older adults with advanced cancer and their caregivers compared with usual social work referral.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT06505122 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial will enroll pairs (dyads) of patients aged 65 or older with stage III–IV cancer and their selected caregivers to compare a Dyadic Life Review (DLR) intervention to care-as-usual (referral to social work). Participants will be randomized to receive the DLR intervention or usual care and will complete assessments of caregiver psychological distress and other measures before and after the intervention. The trial builds on a prior single-arm pilot that showed the adapted DLR was feasible and acceptable to both patients and caregivers. The primary aim is to test feasibility and gather preliminary data on pre-post changes in caregiver psychological distress to inform a larger trial.
Who should consider this trial
Good fit: Ideal candidates are English-speaking patients aged 65 or older with stage III or IV cancer who score ≥4 on the NCCN Distress Thermometer and can enroll with a caregiver aged 50 or older who can consent and participate.
Not a fit: Patients without an available caregiver, those under 65, non-English speakers, or those with low distress (DT score below 4) are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the Dyadic Life Review could reduce caregiver psychological distress and improve emotional well-being and communication between patients and caregivers.
How similar studies have performed: A prior single-arm pilot of the adapted DLR demonstrated feasibility and acceptability, but randomized efficacy has not yet been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Inclusion Criteria: * Age ≥ 65 * Patient has a Stage III or IV advanced cancer diagnosis of any type * Score of 4 or more on National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT)\* * Able to read and understand English Patient Exclusion Criteria: • Unable to identify caregiver to participate in study Caregiver Inclusion Criteria: * One caregiver must enroll with each patient for either subject to be eligible. * Caregivers will be selected by the patient when asked if there is a "significant other, spouse, romantic partner, or adult child with whom you discuss or can be helpful in health-related matters;" * Age 50 or older * Able to reach and understand English Caregiver Exclusion Criteria: • Caregivers unable to provide consent
Where this trial is running
Rochester, New York
- University of Rochester — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: Lee Kehoe
- Email: lee_kehoe@URMC.rochester.edu
- Phone: 1-315-567-3924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.