Clinical trial NCT04867122: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression, Anxiety
Palliative Care
Caregivers
Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: National Cancer Institute (NCI)
name: University of Missouri-Columbia
First posted: 2021-04-30
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a
timeFrame: At the time of enrollment, Week 4, and 30-day follow-up
measure: Change in symptoms of depression as measured by the PROMIS Short Form v1.0 - Depression 8a
timeFrame: At the time of enrollment, Week 4, and 30-day follow-up
Secondary outcomes:
measure: Change in positive aspects of caregiving as measured by Positive Aspects of Caregiving Scale - Short Form (S-PAC; 7 items)
timeFrame: At the time of enrollment, Week 4, and 30-day follow-up
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennslyvania
state: Pennsylvania
Study officials:
affiliation: Washington University School of Medicine
name: Karla Washington, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: