Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

The Washington University

Status: Completed

Conditions: Depression, Anxiety; Cancer; Caregivers; Palliative Care

Treatments: Behavioral: Problem-Solving Therapy; Other: In-depth interviews; Other: Attention-matched Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04867122

202104120

R01CA258311 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 532 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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532 participants in 3 patient groups, including a placebo group

Attention Control

Placebo Comparator group

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.

Treatment:

Other: Attention-matched Control

Problem Solving Therapy Intervention

Experimental group

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.

Treatment:

Behavioral: Problem-Solving Therapy

In-Depth Interviews for non-FCG Stakeholders

Other group

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.

Treatment:

Other: In-depth interviews