Clinical trial NCT03567850: Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC
Official title: Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colo-rectal Cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Mean Physical Health of Patient at Enrollment
timeFrame: At enrollment
measure: Behavioral Health of Patient
timeFrame: At time of enrollment
measure: Mean Change in Physical Health From Baseline to 3-months
timeFrame: At 3 months
measure: Mean Change Physical Health of Patient at 12 Months
timeFrame: At 12 months
measure: Mean Change in Behavioral Health of Patient at 3 Months
timeFrame: At 3 months
measure: Mean Change in Behavioral Health of Patient at 12 Months
timeFrame: At 12 months
measure: Healthcare Utilization of Patients
timeFrame: At 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Ekaternia Noyes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noyes K, Zapf AL, Depner RM, Flores T, Huston A, Rashid HH, McNeal D, Constine LS, Fleming FJ, Wilding GE, Sahler OJZ. Problem-solving skills training in adult cancer survivors: Bright IDEAS-AC pilot study. Cancer Treat Res Commun. 2022;31:100552. doi: 10.1016/j.ctarc.2022.100552. Epub 2022 Mar 25.