A Physical Activity Behavior Change Guide for Prostate Cancer Patients (iTRAIN Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in self efficacy for exercise, assessed by the Self Efficacy for Exercise questionnaire (Evaluation Phase)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Non-English speaking subjects are excluded from this study; the website being developed will only be available in English
研究组 & 干预措施
Group I (BCG website)
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.
干预措施: Computer-Assisted Intervention (Other)
Group I (BCG website)
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.
干预措施: Quality-of-Life Assessment (Other)
Group I (BCG website)
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.
干预措施: Questionnaire Administration (Other)
Group II (passive website)
Patients use a passive website (American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Survivors).
干预措施: Computer-Assisted Intervention (Other)
Group II (passive website)
Patients use a passive website (American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Survivors).
干预措施: Quality-of-Life Assessment (Other)
Group II (passive website)
Patients use a passive website (American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Survivors).
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in self efficacy for exercise, assessed by the Self Efficacy for Exercise questionnaire (Evaluation Phase)
时间窗: Baseline up to 2 months
For the qualitative characteristics collected, univariate summaries (e.g., frequency counts and proportions) will be calculated. For quantitative characteristics, means, standard deviations, medians, and ranges will be computed. The analysis will be conducted as an intent-to-treat efficacy assessment comparing the two interventions. Analyses will examine changes between baseline and follow-up scores on outcome measures by group. Comparisons will be conducted using Generalized Estimating Equations (GEE) with robust (sandwich) variance estimates.
Stage of change for exercise, assessed by the Stage of Change for Exercise questionnaire (Evaluation Phase)
时间窗: Up to 2 months
For the qualitative characteristics collected, univariate summaries (e.g., frequency counts and proportions) will be calculated. For quantitative characteristics, means, standard deviations, medians, and ranges will be computed. The analysis will be conducted as an intent-to-treat efficacy assessment comparing the two interventions. Analyses will examine changes between baseline and follow-up scores on outcome measures by group. Comparisons will be conducted using GEE with robust (sandwich) variance estimates.
Website usability, assessed by qualitative evaluation of interviews and feedback (Development Phase)
时间窗: Up to 9 months
次要结局
- Body weight(Baseline up to 2 months)
- Average activity level for seniors per Community Healthy Activity Model Program for Seniors (CHAMPS) questionnaire(Baseline up to 2 months)
- Measurement of exercise motivation using the Behavioral Regulation In Exercise Questionnaire (BREQ)(Baseline up to 2 months)
- Measurement of fatigue using the Piper Fatigue Scale(Baseline up to 2 months)
- Measurement of quality of life per European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire-core 30 (QLQ-C30) questionnaire(Baseline up to 2 months)
- Self-reported physical activity assessed by the Rapid Assessment of Physical Activity (RAPA)(Baseline up to 2 months)
- Website use and acceptability assessed by questionnaire(Responses collected at 2 months)
研究者
Esther Moe
Principal Investigator
OHSU Knight Cancer Institute