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Completed

NCT Number: NCT03567850

Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC

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.

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 26, 2018
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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