Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants assigned to the intervention arm will receive Problem Solving Skills Training (PSST) consisting of eight one-hour individual weekly sessions. |
|
| Control Arm | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem solving Skills Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At enrollment |
| 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. | At time of enrollment |
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ekaternia Noyes, PhD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35358820 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | At enrollment |
|
Subjects were followed for 12 months after randomization.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kris Attwood | Roswell Park Comprehensive Cancer Center | 716-845-2300 | Kristopher.Attwood@roswellpark.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2021 | Aug 2, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| At 3 months |
| 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. | At 12 months |
| 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. | At 3 months |
| 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. | At 12 months |
| 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. | At 12 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Is Caregiver Also Participating | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | At time of enrollment |
|
|
|
| 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. | A total of 3 patients did not fully complete the FACT-G survey at 3-months. | Posted | Mean | Standard Deviation | score on a scale | At 3 months |
|
|
|
| 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. | A total of 6 patients did not complete the 12-month FACT-G survey. | Posted | Mean | Standard Deviation | score on a scale | At 12 months |
|
|
|
| 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. | A total of 3 patients did not complete the SPSI-R at 3-months. | Posted | Mean | Standard Deviation | score on a scale | At 3 months |
|
|
|
| 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. | A total of 6 subjects did not complete the SPSI-R at 12-months. | Posted | Mean | Standard Deviation | score on a scale | At 12 months |
|
|
|
| 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. | 6 patients did not complete these questions on the final follow-up survey. | Posted | Mean | Standard Deviation | visits | At 12 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| 3-months |
|
|
| 12-months |
|
|
| 3-months |
|
|
| 12-months |
|
|
| Number of Ambulatory Services Used |
|