Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care
- Conditions
- Depression, AnxietyPalliative CareCaregiversCancer
- Interventions
- Other: Attention-matched ControlOther: In-depth interviewsBehavioral: Problem-Solving Therapy
- Registration Number
- NCT04867122
- Lead Sponsor
- Washington University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 530
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Attention Control Attention-matched 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. In-Depth Interviews for non-FCG Stakeholders In-depth interviews 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. Problem Solving Therapy Intervention Problem-Solving Therapy 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.
- Primary Outcome Measures
Name Time Method Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a 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 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 Outcome Measures
Name Time Method 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 * Family caregivers indicate good things that they experience as a caregiver with seven different statements. The caregivers answer with 1=I disagree with this statement a lot; 2=I disagree with this statement a little; 3=I neither agree nor disagree with this statement; 4=I agree with this statement a little; or 5=I agree with this statement a lot.
* Higher scores indicate a more positive caregiving experience
Trial Locations
- Locations (3)
University of Missouri
🇺🇸Columbia, Missouri, United States
University of Pennslyvania
🇺🇸Philadelphia, Pennsylvania, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States