Clinical trial NCT06505122: Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers
Official title: A Pilot Randomized Controlled Trial (RCT) of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Older Adults
Geriatric Oncology
Caregivers
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: DLR Intervention Enrollment Rate
timeFrame: 18 weeks
measure: DLR Intervention Retention Rate
timeFrame: 18 weeks
Secondary outcomes:
measure: Unidimensional Relationship Closeness Scale
timeFrame: 18 weeks
measure: Communication Satisfaction Scale
timeFrame: 18 weeks
measure: Distress Thermometer
timeFrame: 18 weeks
Other outcomes:
Locations:
Study officials:
References: