Trial Summary
What is the purpose of this trial?
This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.
Research Team
KW
Karla Washington, Ph.D.
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for unpaid family caregivers of cancer patients receiving outpatient palliative care, regardless of legal or biological relationship. Participants must be over 18 and involved in the patient's care at one of the clinical sites. They need to consent to join the study.Inclusion Criteria
You must work for or be associated with the healthcare system that is part of the clinical trial.
You are taking care of a family member with cancer who is receiving palliative care as an outpatient. You don't get paid for your caregiving work. It's okay if you don't have a legal or biological relationship with the patient.
Requirements for non-family caregivers who want to participate in the study.
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Treatment Details
Interventions
- Problem-Solving Therapy (Behavioral Intervention)
Trial OverviewThe study tests problem-solving therapy for these caregivers, comparing it with an attention-matched control group. Caregivers are randomly assigned to either receive this specific therapy or participate in interviews that match for time and attention but don't include therapeutic intervention.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Problem Solving Therapy InterventionExperimental Treatment1 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.
Group II: In-Depth Interviews for non-FCG StakeholdersExperimental Treatment1 Intervention
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.
Group III: Attention ControlPlacebo Group1 Intervention
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Trials
2,027
Recruited
2,353,000+
University of Missouri-Columbia
Collaborator
Trials
387
Recruited
629,000+
University of Pennsylvania
Collaborator
Trials
2,118
Recruited
45,270,000+
National Cancer Institute (NCI)
Collaborator
Trials
14,080
Recruited
41,180,000+