Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

NCT04867122 | Completed

• 2 other identifiers: 202104120R01CA258311
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 3

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.

Conditions

Palliative Care; Caregivers; Cancer; Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• 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

Study Arms (3)

Attention Control

PLACEBO COMPARATOR

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.

Other: Attention-matched Control

Problem Solving Therapy Intervention

EXPERIMENTAL

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.

Behavioral: Problem-Solving Therapy

In-Depth Interviews for non-FCG Stakeholders

OTHER

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.

Other: In-depth interviews

Interventions

Attention-matched Control OTHER

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.

Attention Control

In-depth interviews OTHER

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.

In-Depth Interviews for non-FCG Stakeholders

Problem-Solving Therapy BEHAVIORAL

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.

Problem Solving Therapy Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Younger than 18 years of age
• Paid caregiver
• Younger than 18 years of age
• Not employed by or affiliated with the healthcare system housing one of the participating clinical sites.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Pennsylvania: collaborator
• National Cancer Institute (NCI): collaborator
• University of Missouri-Columbia: collaborator

Study Sites (3)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Pennslyvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

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

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Karla Washington, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 30, 2021
• Study Start: January 24, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)