Colo-rectal Cancer
Conditions
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
Interventions
BEHAVIORALProblem solving Skills Training
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.
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Physical Health of Patient at Enrollment | 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. |
| Behavioral Health of Patient | 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. |
| Mean Change in Physical Health From Baseline to 3-months | 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. |
| Mean Change Physical Health of Patient at 12 Months | 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. |
| Mean Change in Behavioral Health of Patient at 3 Months | 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. |
| Mean Change in Behavioral Health of Patient at 12 Months | 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. |
| Healthcare Utilization of Patients | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants assigned to the intervention arm will receive Problem Solving Skills Training (PSST) consisting of eight one-hour individual weekly sessions.
Problem solving Skills Training: 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. | 25 |
| Control Arm Care As Usual Group (CAU): Participants randomized to the CAU group will be observed under naturalistic conditions.
Problem solving Skills Training: 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. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Intervention | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 9.4 | 62.3 years STANDARD_DEVIATION 8.4 | 63.1 years STANDARD_DEVIATION 8.9 |
| Age, Customized Age 40-49 | 2 Participants | 2 Participants | 4 Participants |
| Age, Customized Age 50-59 | 6 Participants | 6 Participants | 12 Participants |
| Age, Customized Age 60-69 | 13 Participants | 12 Participants | 25 Participants |
| Age, Customized Age 70-79 | 2 Participants | 4 Participants | 6 Participants |
| Age, Customized Age 80+ | 2 Participants | 1 Participants | 3 Participants |
| Diagnosis Breast Cancer | 10 Participants | 11 Participants | 21 Participants |
| Diagnosis Colon and Rectal Cancer | 10 Participants | 10 Participants | 20 Participants |
| Diagnosis Prostate Cancer | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 24 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Is Caregiver Also Participating No | 20 Participants | 13 Participants | 33 Participants |
| Is Caregiver Also Participating Yes | 5 Participants | 12 Participants | 17 Participants |
| Marital Status Divorced | 7 Participants | 6 Participants | 13 Participants |
| Marital Status Married | 15 Participants | 18 Participants | 33 Participants |
| Marital Status Other | 1 Participants | 1 Participants | 2 Participants |
| Marital Status Single | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 22 Participants | 44 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Behavioral Health of Patient
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.
Time frame: At time of enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Behavioral Health of Patient | 12.2 score on a scale | Standard Deviation 3.7 |
| Control Arm | Behavioral Health of Patient | 11.7 score on a scale | Standard Deviation 3.7 |
Primary
Healthcare Utilization of Patients
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.
Time frame: At 12 months
Population: 6 patients did not complete these questions on the final follow-up survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Healthcare Utilization of Patients | Number of Hospital Visits | 0.0 visits | Standard Deviation 0 |
| Intervention | Healthcare Utilization of Patients | Number of Emergency Room Visits | 0.0 visits | Standard Deviation 0 |
| Intervention | Healthcare Utilization of Patients | Number of Ambulatory Services Used | 6.5 visits | Standard Deviation 4.7 |
| Control Arm | Healthcare Utilization of Patients | Number of Emergency Room Visits | 0.3 visits | Standard Deviation 0.9 |
| Control Arm | Healthcare Utilization of Patients | Number of Hospital Visits | 0.4 visits | Standard Deviation 0.9 |
| Control Arm | Healthcare Utilization of Patients | Number of Ambulatory Services Used | 5.7 visits | Standard Deviation 3.9 |
Primary
Mean Change in Behavioral Health of Patient 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.
Time frame: At 12 months
Population: A total of 6 subjects did not complete the SPSI-R at 12-months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Mean Change in Behavioral Health of Patient at 12 Months | baseline | 12.2 score on a scale | Standard Deviation 3.7 |
| Intervention | Mean Change in Behavioral Health of Patient at 12 Months | 12-months | 13.8 score on a scale | Standard Deviation 3.1 |
| Control Arm | Mean Change in Behavioral Health of Patient at 12 Months | baseline | 11.7 score on a scale | Standard Deviation 3.7 |
| Control Arm | Mean Change in Behavioral Health of Patient at 12 Months | 12-months | 11.7 score on a scale | Standard Deviation 4.5 |
Primary
Mean Change in Behavioral Health of Patient 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.
Time frame: At 3 months
Population: A total of 3 patients did not complete the SPSI-R at 3-months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Mean Change in Behavioral Health of Patient at 3 Months | baseline | 12.2 score on a scale | Standard Deviation 3.7 |
| Intervention | Mean Change in Behavioral Health of Patient at 3 Months | 3-months | 13.4 score on a scale | Standard Deviation 3.8 |
| Control Arm | Mean Change in Behavioral Health of Patient at 3 Months | baseline | 11.7 score on a scale | Standard Deviation 3.7 |
| Control Arm | Mean Change in Behavioral Health of Patient at 3 Months | 3-months | 11.6 score on a scale | Standard Deviation 4.2 |
Primary
Mean Change in Physical Health From Baseline to 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.
Time frame: At 3 months
Population: A total of 3 patients did not fully complete the FACT-G survey at 3-months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Mean Change in Physical Health From Baseline to 3-months | baseline | 77.2 score on a scale | Standard Deviation 21.3 |
| Intervention | Mean Change in Physical Health From Baseline to 3-months | 3-months | 82.4 score on a scale | Standard Deviation 19.6 |
| Control Arm | Mean Change in Physical Health From Baseline to 3-months | baseline | 82.7 score on a scale | Standard Deviation 16.7 |
| Control Arm | Mean Change in Physical Health From Baseline to 3-months | 3-months | 82.4 score on a scale | Standard Deviation 20.2 |
Primary
Mean Change Physical Health of Patient 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.
Time frame: At 12 months
Population: A total of 6 patients did not complete the 12-month FACT-G survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Mean Change Physical Health of Patient at 12 Months | baseline | 77.2 score on a scale | Standard Deviation 21.3 |
| Intervention | Mean Change Physical Health of Patient at 12 Months | 12-months | 87.1 score on a scale | Standard Deviation 21.5 |
| Control Arm | Mean Change Physical Health of Patient at 12 Months | baseline | 82.7 score on a scale | Standard Deviation 16.7 |
| Control Arm | Mean Change Physical Health of Patient at 12 Months | 12-months | 82.3 score on a scale | Standard Deviation 18.9 |
Primary
Mean Physical Health of Patient 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.
Time frame: At enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Mean Physical Health of Patient at Enrollment | 77.2 score on a scale | Standard Deviation 21.3 |
| Control Arm | Mean Physical Health of Patient at Enrollment | 82.7 score on a scale | Standard Deviation 16.7 |