Prostate Carcinoma Clinical Trial
Official title:
A Physical Activity Behavior Change Guide for Prostate Cancer Patients (iTRAIN Study)
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.
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.
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