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Dyadic Life Review Intervention for Older Patients with Advanced Cancer) and Their Caregivers

Not Applicable
Not yet recruiting
Conditions
Cancer
Interventions
Behavioral: Dyadic Life Review
Registration Number
NCT06505122
Lead Sponsor
University of Rochester
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dyadic Life ReviewDyadic Life ReviewThe Dyadic Life Review Arm (DLR) consists of 8 sessions delivered by a trained licensed clinician. Each session facilitates a recall of each phase of life. The patient and caregiver will each be asked structured questions to prompt reminiscence of memories from that phase of life. Interventionists are able to use clinical judgment to prompt further or ask follow-up questions or reflections. Additionally, the patient and caregiver will be asked to respond to the other dyad member's memory or reflection. Each session will have flexibility for clinical judgement.
Primary Outcome Measures
NameTimeMethod
DLR Intervention Enrollment Rate18 weeks

Evaluate the feasibility of DLR in older patients and caregivers based on enrollment rate.

DLR Intervention Retention Rate18 weeks

Evaluate the feasibility of DLR in older patients and caregivers based on retention rate.

Secondary Outcome Measures
NameTimeMethod
Unidimensional Relationship Closeness Scale18 weeks

Quality of relationship with 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. This is a 12-item scale, rated from 1-7 (1=strongly agree, 7=strongly disagree), with a possible total of 84; a higher score indicates a higher level of closeness.

Distress Thermometer18 weeks

A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress.

Communication Satisfaction Scale18 weeks

The observation of each partner's level of satisfaction with various aspects of their communication. This is a 12-item scale, rated from 1-5 (1=not at all satisfied, 5=extremely satisfied), with a possible total of 60; a higher score indicates greater satisfaction with communication.

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