Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

Not Applicable

• Conditions: Depression, Anxiety; Palliative Care; Caregivers; Cancer

• 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.

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-04-30
• Study Start: 2022-01-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University of Pennslyvania; 🇺🇸 Philadelphia, Pennsylvania, United States