N/A
N=50
Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC
Colo-rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03567850 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Mean Physical Health of Patient at Enrollment — 77.2; 82.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Problem solving Skills Training (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Physical Health of Patient at Enrollment |
77.2; 82.7 | — |
| PRIMARY Behavioral Health of Patient |
12.2; 11.7 | — |
| PRIMARY Mean Change in Physical Health From Baseline to 3-months |
77.2; 82.7; 82.4; 82.4 | — |
| PRIMARY Mean Change Physical Health of Patient at 12 Months |
77.2; 82.7; 87.1; 82.3 | — |
| PRIMARY Mean Change in Behavioral Health of Patient at 3 Months |
12.2; 11.7; 13.4; 11.6 | — |
| PRIMARY Mean Change in Behavioral Health of Patient at 12 Months |
12.2; 11.7; 13.8; 11.7 | — |
| PRIMARY Healthcare Utilization of Patients |
0.0; 0.4; 0.0; 0.3; 6.5; 5.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03567850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.