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Problem-Solving Therapy for Caregiver Stress
N/A
Waitlist Available
Led By Karla Washington, Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be 18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of enrollment, week 4, and 30-day follow-up
Awards & highlights
Study Summary
This trial is testing a problem-solving therapy intervention for family caregivers of cancer patients receiving outpatient palliative care.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since this trial involves psychological therapy rather than medication, traditional side effects like those seen with drugs aren't expected. However, participants may experience emotional discomfort discussing personal issues during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of enrollment, week 4, and 30-day follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of enrollment, week 4, and 30-day follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a
Change in symptoms of depression as measured by the PROMIS Short Form v1.0 - Depression 8a
Secondary outcome measures
Change in positive aspects of caregiving as measured by Positive Aspects of Caregiving Scale - Short Form (S-PAC; 7 items)
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Problem-Solving Therapy
2019
Completed Phase 4
~880
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaOTHER
361 Previous Clinical Trials
627,464 Total Patients Enrolled
1 Trials studying Palliative Care
83 Patients Enrolled for Palliative Care
Washington University School of MedicineLead Sponsor
1,933 Previous Clinical Trials
2,299,195 Total Patients Enrolled
1 Trials studying Palliative Care
242 Patients Enrolled for Palliative Care
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,879,558 Total Patients Enrolled
3 Trials studying Palliative Care
16,745 Patients Enrolled for Palliative Care
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am 18 years old or older.Requirements for family members or friends who will be caring for the patient during the study.You must agree to take part in the study.You agree to take part in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Control
- Group 2: Problem Solving Therapy Intervention
- Group 3: In-Depth Interviews for non-FCG Stakeholders
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor currently in need of participants?
"This particular trial, which was first posted on January 24th 2022 and recently updated in August 15th of the same year, is not currently recruiting. However, there are 1,715 other clinical trials actively seeking participants at this time."
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