Skip to main content
OpenTrials
Completed

NCT Number: NCT04867122

Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cancer Caregivers Depression Mental Disorders Neoplasms Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri, Columbia, Missouri, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a

    Time frame: 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.

  2. Change in symptoms of depression as measured by the PROMIS Short Form v1.0 - Depression 8a

    Time frame: 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 outcomes

  1. Change in positive aspects of caregiving as measured by Positive Aspects of Caregiving Scale - Short Form (S-PAC; 7 items)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Missouri-Columbia
  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.