Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Colo-rectal Cancer

Treatments: Behavioral: Problem solving Skills Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03567850

I 65518

Details and patient eligibility

About

The aim of this 2-year study will assess the acceptability and feasibility of offering Problem Solving Skills Therapy (PSST) to cancer survivors and their caregivers focusing on the highest risk patients with distress.

Full description

At Roswell Park Comprehensive Cancer Center, in collaboration with the University at Buffalo School of Public Health and Health Professions and the University of Rochester, we are looking for adult cancer patients to participate in our new project designed to facilitate recovery from cancer and help cancer survivors lead better, more productive lives. The ideal subjects are individuals who have completed treatment for stage I-III cancer and speak English. Participants will be randomized into two groups: 8 weekly 1-hour long sessions of problem solving skills therapy delivered by a trained therapist vs. care as usual. Bright IDEAS Adult Cancer (Bright IDEAS-AC) therapy will be delivered in the most patient-friendly way. Sessions will be face-to-face at the location of patient choice (hospital, clinic, or participant's home) or over the phone. A supportive other or caregiver is also invited to participate in this study. This project does not involve any experimental drugs and does not affect the regular care or patient relationship with doctor(s).

At the time of enrollment, after 3 months and after 6 months, all participants in the intervention and control arms, as well as any participating supportive others/caregivers will be asked about their healthcare utilization since the last assessment including primary care, specialist and emergency department visits and any hospital stays. During the same three time points, both patients and supportive others/caregivers will be asked to fill in 4 short questionnaires assessing their problem solving skills, health status, mood and function

Enrollment: 50 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stage I-III Colorectal Cancer, Breast, Bladder or Prostate Cancer
• meet the screening criteria for psychological distress (NCCN Distress >2)
• be able to speak English
• have a 5-year survival rate of 50% or greater as deemed by their oncologist, surgeon,or other relevant attending physician (suggesting a reasonable rate of cure or prolonged medical survival with state-of-the-art medical care)
• be willing to provide written informed consent to participate in the study which includes several clinical evaluations, provide access to medical records/PCP, and allow all interviews and PSST therapy sessions to be audiotaped.
• Among patients treated in the urban centers, we will specifically target patients who live more than 40 miles away from the clinic as they are more likely to experience problems with access to care.
• Age 21 or older

Exclusion criteria

• a diagnosis of mental retardation,
• and/or acute suicidal behavior

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants assigned to the intervention arm will receive Problem Solving Skills Training (PSST) consisting of eight one-hour individual weekly sessions.

Treatment:

Behavioral: Problem solving Skills Training

Control Arm

Active Comparator group

Description:

Care As Usual Group (CAU): Participants randomized to the CAU group will be observed under naturalistic conditions. Both PSST and CAU participants and their clinicians (PCP and oncology providers) will be allowed to use any clinically appropriate medical and behavioral care without restriction (e.g., care management, rehabilitation, behavioral therapy, palliative care) or refer patients to social and community services (e.g., peer support, county cancer services program or aging services). The CAU participants will undergo the same evaluation protocol as the PSST group

Treatment:

Behavioral: Problem solving Skills Training