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Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04867122
Enrollment
532
Registered
2021-04-30
Start date
2022-01-24
Completion date
2025-12-01
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Anxiety, Palliative Care, Caregivers, Cancer

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.

Interventions

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.

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.

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.

Sponsors

University of Pennsylvania
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
University of Missouri-Columbia
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

The randomized portion of the trial will enroll 540 family caregivers. An additional portion of the trial will enroll 30 key stakeholders to participate in individual interviews focused on potential barriers and facilitators to adoption of the problem-solving therapy (PST) intervention into clinical practice.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8aAt the time of enrollment, Week 4, and 30-day follow-upFamily 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 8aAt the time of enrollment, Week 4, and 30-day follow-upFamily caregivers indicate the frequency with which they experience eight different symptoms of depression (8 items); higher scores reflect higher depression severity

Secondary

MeasureTime frameDescription
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026