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Trial Title:
Dyadic Life Review Intervention for Older Patients with Advanced Cancer) and Their Caregivers
NCT ID:
NCT06505122
Condition:
Cancer
Conditions: Keywords:
Older Adults
Geriatric Oncology
Caregivers
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Dyadic Life Review
Description:
DLR is an intervention that will promote relationship closeness, communication, and
psychological distress in both older adults and caregivers.
Arm group label:
Dyadic Life Review
Other name:
DLR
Summary:
The purpose of this study is to test the feasibility of a pilot Randomized Controlled
Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced
cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to
social work.
Detailed description:
The purpose of this study is to test the feasibility of a pilot Randomized Controlled
Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced
cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to
social work. The study will enroll dyads (pairs) of caregivers and older patients with
advanced cancer and dyads of caregivers and patients with advanced cancer. A previous
single-arm study was performed testing the feasibility of the adapted DLR intervention in
older adults with advanced cancer and their caregivers. The single-arm pilot demonstrated
DLR was feasible and acceptable by both patients and caregivers. This innovative pilot
study will gather data to test the feasibility of a pilot and examine pre-post
intervention changes in caregiver psychological distress.
Criteria for eligibility:
Criteria:
Patient Inclusion Criteria:
- Age ≥ 65
- Within 180 days of Stage III or IV advanced cancer diagnosis, any type of cancer
- 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 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 "significant
other, spouse, or romantic partner 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
- Able to read and understand English
Caregiver Exclusion Criteria:
• Caregivers unable to provide consent
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
July 31, 2026
Lead sponsor:
Agency:
University of Rochester
Agency class:
Other
Source:
University of Rochester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06505122
