Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

Cancer Clinical Trial

Official title:

Problem-Solving Therapy for Cancer Caregivers: A Randomized Clinical Trial in Outpatient Palliative Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04867122
• Other study ID #: 202104120
• Secondary ID: R01CA258311
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 530
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Caregivers
• Depression
• Depression, Anxiety
• Palliative Care

Intervention

Behavioral:
• Problem-Solving Therapy
Over an approximately 3-week period, family caregivers randomized to the intervention study arm will learn and apply a problem-solving approach based on the ADAPT model, which encourages participants to follow five steps when solving caregiving problems: 1) focus on adopting a positive attitude to problem solving, 2) define the problem and set goals, 3) generate a list of alternative solutions to the problem, 4) predict consequences of the alternative solutions, and 5) try implementing the most promising solution from among the list of alternatives. The intervention will be delivered by a trained interventionist over the course of three structured sessions via telephone or videoconferencing technology, depending on the FCG's preference. Session content will be summarized in an intervention manual, which we will provide to all intervention participants. Sessions will last approximately 45-60 minutes.

Other:
• Attention-matched Control
Over an approximately 3-week period, family caregivers randomized to the attention control study arm will participate in informal conversations ("friendly visits") with a trained member of the research team.
• In-depth interviews
The 30 key stakeholders interviews will discuss how the PST intervention fits into existing clinical practice and institutional values, what might incentivize adoption of the PST intervention, and how the intervention compares to alternative existing or proposed programs.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri
United States	University of Pennslyvania	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI), University of Missouri-Columbia, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a	Family caregivers indicate the frequency with which they experience eight different symptoms of anxiety (8 items); higher scores reflect higher anxiety severity.	At the time of enrollment, Week 4, and 30-day follow-up
Primary	Change in symptoms of depression as measured by the PROMIS Short Form v1.0 - Depression 8a	Family caregivers indicate the frequency with which they experience eight different symptoms of depression (8 items); higher scores reflect higher depression severity	At the time of enrollment, Week 4, and 30-day follow-up
Secondary	Change in positive aspects of caregiving as measured by Positive Aspects of Caregiving Scale - Short Form (S-PAC; 7 items)	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	At the time of enrollment, Week 4, and 30-day follow-up

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine