Problem-Solving Therapy for Cancer Caregivers: A Randomized Clinical Trial in Outpatient Palliative Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 532
- Locations
- 4
- Primary Endpoint
- Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a
Study Overview
Brief Summary
This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.
Detailed Description
This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care. Study participants will be randomized to receive either a three-session problem-solving therapy intervention in addition to usual care or three sessions of attention-matched control in addition to usual care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •for Family Caregivers (FCGs)
- •Must be 18 years of age or older
- •Must serve as the unpaid family caregiver of a patient with cancer receiving outpatient palliative care from one of the participating clinical sites. As is common in caregiving research, we will define "family caregiver" as anyone substantially involved in a patient's care on an unpaid basis; a legal or biological relationship will not be required
- •Must consent to participate
- •Inclusion Criteria for Non-Family Caregiver Stakeholders
- •Must be 18 years of age or older
- •Must be employed by or affiliated with the healthcare system housing one of the participating clinical sites.
- •Must consent to participate.
Exclusion Criteria
- •for Family Caregivers (FCGs)
- •Younger than 18 years of age
- •Paid caregiver
- •Exclusion Criteria for Non-Family Caregiver Stakeholders
- •Younger than 18 years of age
- •Not employed by or affiliated with the healthcare system housing one of the participating clinical sites.
Arms & Interventions
Attention Control
Family caregivers in the attention control study arm will receive three sessions of attention-matched control in addition to the services and support provided as part of usual outpatient palliative care. Attention-matched control will consist of three "friendly visits" with a trained research staff person.
Intervention: Attention-matched Control (Other)
Problem Solving Therapy Intervention
Family caregivers in the intervention study arm will participate in three problem-solving therapy sessions with a trained interventionist in addition to receiving the services and support provided as part of usual outpatient palliative care.
Intervention: Problem-Solving Therapy (Behavioral)
In-Depth Interviews for non-FCG Stakeholders
Each year of the project, the investigators will recruit 6 key stakeholders to participate in individual interviews focused on potential barriers and facilitators to adoption of the PST intervention into clinical practice for a total of 30 unique stakeholders who will be interviewed over the duration of this 5-year study.
Intervention: In-depth interviews (Other)
Outcomes
Primary Outcomes
Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a
Time Frame: At the time of enrollment, Week 4, and 30-day follow-up
Family caregivers indicate the frequency with which they experience eight different symptoms of anxiety (8 items); higher scores reflect higher anxiety severity.
Change in symptoms of depression as measured by the PROMIS Short Form v1.0 - Depression 8a
Time Frame: At the time of enrollment, Week 4, and 30-day follow-up
Family caregivers indicate the frequency with which they experience eight different symptoms of depression (8 items); higher scores reflect higher depression severity
Secondary Outcomes
- Change in positive aspects of caregiving as measured by Positive Aspects of Caregiving Scale - Short Form (S-PAC; 7 items)(At the time of enrollment, Week 4, and 30-day follow-up)