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Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

Primary Purpose

Depression, Anxiety, Palliative Care, Caregivers

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Problem-Solving Therapy
Attention-matched Control
In-depth interviews
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Missouri
  • Washington University School of Medicine
  • University of Pennslyvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Other

Arm Label

Attention Control

Problem Solving Therapy Intervention

In-Depth Interviews for non-FCG Stakeholders

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2021
Last Updated
October 10, 2023
Sponsor
Washington University School of Medicine
Collaborators
University of Pennsylvania, National Cancer Institute (NCI), University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04867122
Brief Title
Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care
Official Title
Problem-Solving Therapy for Cancer Caregivers: A Randomized Clinical Trial in Outpatient Palliative Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of Pennsylvania, National Cancer Institute (NCI), University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Palliative Care, Caregivers, Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The randomized portion of the trial will enroll 500 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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Attention Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Problem Solving Therapy Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
In-Depth Interviews for non-FCG Stakeholders
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Problem-Solving Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Attention-matched Control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
In-depth interviews
Intervention Description
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 Outcome Measure Information:
Title
Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a
Description
Family caregivers indicate the frequency with which they experience eight different symptoms of anxiety (8 items); higher scores reflect higher anxiety severity.
Time Frame
At the time of enrollment, Week 4, and 30-day follow-up
Title
Change in symptoms of depression as measured by the PROMIS Short Form v1.0 - Depression 8a
Description
Family caregivers indicate the frequency with which they experience eight different symptoms of depression (8 items); higher scores reflect higher depression severity
Time Frame
At the time of enrollment, Week 4, and 30-day follow-up
Secondary Outcome Measure Information:
Title
Change in positive aspects of caregiving as measured by Positive Aspects of Caregiving Scale - Short Form (S-PAC; 7 items)
Description
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
Time Frame
At the time of enrollment, Week 4, and 30-day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karla Washington, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Pennslyvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

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