Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants assigned to the intervention arm will receive Problem Solving Skills Training (PSST) consisting of eight one-hour individual weekly sessions.
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Participants will be encouraged to identify specific problems particularly relevant to them and to their family's situation (instead of providing them with standardized examples) to be discussed and "solved" during the PSST sessions.
The eight sessions of PSST will be organized in a systematized, therapeutic manner.
Session 1 will be face-to-face and devoted to rapport building and understanding relevant social and medical information.
The therapist (RA) will introduce PSST and the Bright IDEAS paradigm, present worksheets to guide PSST homework assignments, and give an overview of subsequent sessions.
Starting at session 2, participants will continue training over the phone, with the same general structure and format.
In sessions 2-7, the therapist and patient, with a supportive other (SO) if available, will review the patient's identified problems and work on application of problem-solving strategies and skills learned earlier.
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|
Active Comparator: Control Arm
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
|
Participants will be encouraged to identify specific problems particularly relevant to them and to their family's situation (instead of providing them with standardized examples) to be discussed and "solved" during the PSST sessions.
The eight sessions of PSST will be organized in a systematized, therapeutic manner.
Session 1 will be face-to-face and devoted to rapport building and understanding relevant social and medical information.
The therapist (RA) will introduce PSST and the Bright IDEAS paradigm, present worksheets to guide PSST homework assignments, and give an overview of subsequent sessions.
Starting at session 2, participants will continue training over the phone, with the same general structure and format.
In sessions 2-7, the therapist and patient, with a supportive other (SO) if available, will review the patient's identified problems and work on application of problem-solving strategies and skills learned earlier.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Physical Health of Patient at Enrollment
Time Frame: At enrollment
|
From all patients in the intervention and control arms, we will collect patient on physical health using the Functional Assessment of Cancer Therapy - disease specific. FACT-G is a 27-item questionnaire designed to measure four domains of health-related quality of life in cancer patients based on the past 7 days: physical, social, emotional, and functional well-being (score range is 1-108; higher scores indicate better quality of life). The scale's ability to discriminate patients on the basis of performance status and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Differences of 5-7 points are considered clinically significant. |
At enrollment
|
|
Behavioral Health of Patient
Time Frame: At time of enrollment
|
From all patients in the intervention and control arms, we will collect patient self-report data on problem solving skills,using the Social Problem-Solving Inventory-Revised (SPSI-R) SPSI-R is a 25-item self-report tool linked to a multidimensional model of problem-solving skills. SPSI-R:S has been demonstrated to have strong reliability and validity estimates. The scale includes 5 sub-scales grouped into two decision-making styles: constructive (Positive Problem Orientation and Rational Problem Solving) and dysfunctional (Negative Problem Orientation, Impulsivity/ Carelessness, and Avoidance). Each subscale and the total SPSI-R:S scores are expressed on a 0-20 scale; higher scores indicate better skills. |
At time of enrollment
|
|
Mean Change in Physical Health From Baseline to 3-months
Time Frame: At 3 months
|
From all patients in the intervention and control arms, we will collect patient on physical health using the Functional Assessment of Cancer Therapy - Disease Specific (FACT) FACT-G is a 27-item questionnaire designed to measure four domains of health-related quality of life in cancer patients based on the past 7 days: physical, social, emotional, and functional well-being (score range is 1-108; higher scores indicate better quality of life). The scale's ability to discriminate patients on the basis of performance status and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Differences of 5-7 points are considered clinically significant. The mean change was calculated as the difference between the 3-month measurement and the baseline measurement. |
At 3 months
|
|
Mean Change Physical Health of Patient at 12 Months
Time Frame: At 12 months
|
From all patients in the intervention and control arms, we will collect patient on physical health using the Functional Assessment of Cancer Therapy (FACT) FACT-G is a 27-item questionnaire designed to measure four domains of health-related quality of life in cancer patients based on the past 7 days: physical, social, emotional, and functional well-being (score range is 1-108; higher scores indicate better quality of life). The scale's ability to discriminate patients on the basis of performance status and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Differences of 5-7 points are considered clinically significant. |
At 12 months
|
|
Mean Change in Behavioral Health of Patient at 3 Months
Time Frame: At 3 months
|
From all patients in the intervention and control arms, we will collect patient self-report data on problem solving skills,using the Social Problem-Solving Inventory-Revised (SPSI-R) SPSI-R is a 25-item self-report tool linked to a multidimensional model of problem-solving skills. SPSI-R:S has been demonstrated to have strong reliability and validity estimates. The scale includes 5 sub-scales grouped into two decision-making styles: constructive (Positive Problem Orientation and Rational Problem Solving) and dysfunctional (Negative Problem Orientation, Impulsivity/ Carelessness, and Avoidance). Each subscale and the total SPSI-R:S scores are expressed on a 0-20 scale; higher scores indicate better skills. |
At 3 months
|
|
Mean Change in Behavioral Health of Patient at 12 Months
Time Frame: At 12 months
|
From all patients in the intervention and control arms, we will collect patient self-report data on problem solving skills,using the Social Problem-Solving Inventory-Revised (SPSI-R) SPSI-R is a 25-item self-report tool linked to a multidimensional model of problem-solving skills. SPSI-R:S has been demonstrated to have strong reliability and validity estimates. The scale includes 5 sub-scales grouped into two decision-making styles: constructive (Positive Problem Orientation and Rational Problem Solving) and dysfunctional (Negative Problem Orientation, Impulsivity/ Carelessness, and Avoidance). Each subscale and the total SPSI-R:S scores are expressed on a 0-20 scale; higher scores indicate better skills. |
At 12 months
|
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Healthcare Utilization of Patients
Time Frame: At 12 months
|
From all patients in the intervention and control arms, we will collect patient self-report data by asking the patients about their healthcare utilization since the last study assessment including primary care, specialist and ED visits, use of supportive services and any hospital stays.
|
At 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ekaternia Noyes, PhD, Roswell Park Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 65518
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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