Clinical trial NCT02869412: Computer-Based Behavior Change Guide in Increasing Physical Activity in Patients With Prostate Cancer Who Have Received Androgen Deprivation Therapy
Official title: A Physical Activity Behavior Change Guide for Prostate Cancer Patients (iTRAIN Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-08-17
Enrollment: 56
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized pilot clinical trial studies how well a computer-based behavior change guide works in increasing physical activity in patients with prostate cancer who have received androgen deprivation therapy. A computer-based behavior change guide website may increase physical activity level for prostate cancer survivors and help doctors understand what outcomes related to becoming physically active are most important to patients with prostate cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Engage with prostate cancer patients (PCPs) who have received or are currently on androgen deprivation therapy (ADT) to develop a computer-based behavior change guide (BCG) for PCPs to provide fundamental information about benefits of exercise for their individual capabilities and goals and provide a personalized physical activity plan. (Development Phase) II. Engage with PCPs to understand what outcomes are most important to them related to becoming active (e.g., helped me manage side-effects of treatment, reduced fatigue) and develop measures to evaluate these patient-centered outcomes. (Development Phase) III. Evaluate the BCG in a study comparing the personalized computer-based BCG with physical activity recommendations provided via a passive website (American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Survivors) among PCPs who have received ADT. (Evaluation Phase)

OUTLINE:

DEVELOPMENT PHASE: Patients view mock-ups of the BCG web design on a computer, iPad, or printed color paper and provide feedback with a one-on-one interview or separately using the think/talk aloud method followed by a one-on-one interview. After completion of these design rounds, patients use the BCG website and provide individual feedback.

EVALUATION PHASE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients use the BCG website which will collect personal information including individual health priorities/goals, demographics (i.e. age, ethnicity), health information (i.e. weight, height, cancer history, other health conditions), individual capabilities, physical activity level, and exercise preferences. Patients then receive a report with a personalized physical activity plan.

GROUP II: Patients use a passive website (American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Survivors).

After completion of study, patients are followed up at 2 months.

Eligibility criteria: Inclusion Criteria:

* Prostate cancer (PCa) diagnosis
* Able to read English on a computer screen
* Signed an Institutional Review Board (IRB)-approved informed consent
* EVALUATION PHASE
* Underactive (defined as physically active for less than 30 minutes per day fewer than 2 days per week)
* Access to a computer at home or public location

Exclusion Criteria:

* Non-English speaking subjects are excluded from this study; the website being developed will only be available in English

Primary outcomes:
measure: Change in self efficacy for exercise, assessed by the Self Efficacy for Exercise questionnaire (Evaluation Phase)
timeFrame: Baseline up to 2 months
measure: Stage of change for exercise, assessed by the Stage of Change for Exercise questionnaire (Evaluation Phase)
timeFrame: Up to 2 months
measure: Website usability, assessed by qualitative evaluation of interviews and feedback (Development Phase)
timeFrame: Up to 9 months
Secondary outcomes:
measure: Average activity level for seniors per Community Healthy Activity Model Program for Seniors (CHAMPS) questionnaire
timeFrame: Baseline up to 2 months
measure: Body weight
timeFrame: Baseline up to 2 months
measure: Measurement of exercise motivation using the Behavioral Regulation In Exercise Questionnaire (BREQ)
timeFrame: Baseline up to 2 months
measure: Measurement of fatigue using the Piper Fatigue Scale
timeFrame: Baseline up to 2 months
measure: Measurement of quality of life per European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire-core 30 (QLQ-C30) questionnaire
timeFrame: Baseline up to 2 months
measure: Self-reported physical activity assessed by the Rapid Assessment of Physical Activity (RAPA)
timeFrame: Baseline up to 2 months
measure: Website use and acceptability assessed by questionnaire
timeFrame: Responses collected at 2 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Esther Moe
role: PRINCIPAL_INVESTIGATOR
References: