The Intensive Diet and Exercise Adherence Trial - Pilot (IDEA-P): A Feasibility Study of a Lifestyle Intervention in Men Undergoing Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in FL as measured by the abbreviated Late-Life Function, Disability Inventory (LL-FDI), and Mobility-Related Self-Efficacy
研究概览
简要总结
This randomized pilot clinical trial studies intensive diet and exercise or standard of care in improving physical function and quality of life in patients with prostate cancer undergoing androgen deprivation therapy. Diet and exercise may help improve physical function and quality of life in prostate cancer patients. It is not yet known whether intensive diet and exercise is more effective than standard of care in improving physical function and quality of life in patients with prostate cancer undergoing androgen deprivation therapy.
详细描述
PRIMARY OBJECTIVES:
I. To compare the effects of the intensive lifestyle intervention and standard of care treatments on functional limitations (FL), body composition (BC), and quality of life (QOL) in prostate cancer (PC) patients on androgen deprivation therapy (ADT).
II. To determine the feasibility of delivering an intensive lifestyle exercise and dietary intervention to PC patients undergoing ADT.
III. To identify the intermediate variables that account for the beneficial effect of the lifestyle intervention on functional limitations and QOL.
OUTLINE: Patients are randomized to 1 of 2 arms.
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
- Single (Participant)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with PC: histologically-defined diagnosis of PC based upon providing pathology reports and staging studies
- •Initiating ADT: will be initiating a planned course of at least 3 months of ADT; the ADT is defined as: (a) surgical castration; (b) gonadotropin-releasing hormone (GNRH) antagonist alone; (c) GNRH antagonist with oral androgen receptor blockade, and (d) GNRH antagonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors; we will not include men with only oral antiandrogen therapy such as 5-alpha reductase inhibitors alone or oral antiandrogens alone, as they do not produce castrate levels of testosterone
- •Stage: at enrollment, all men have stage IV disease, which is our major presentation to the medical oncology prostate program; two groups are typical; the first involves men who usually present for initial diagnosis with minimally metastatic disease and elevated prostate-specific antigen (PSA) and staging studies with modest nodal enlargement or bone lesions, typically asymptotic; the second group involves men we have been monitoring after local therapy, surgery or radiation, but who have a slow rise in PSA indicating failure of curative therapy; at some point in time asymptomatic metastases are noted on scans, and ADT is offered
- •Sedentary lifestyle: fewer than 60 minutes of participation in structured moderate intensity physical activity each week
- •Health status: all participants must be free of active cardiovascular disease (CVD), unstable angina, arrhythmia, or severe systemic disease that would make moderate intensity exercise participation unsafe; men with prior CVD that have had successful intervention/treatment that are no longer have active CVD and are medically cleared to safely exercise by their physician will be eligible to participate in the study
- •Consents: willing to give an informed consent and sign a Health Insurance Portability and Accountability Act (HIPPA) authorization form
- •Physician medical clearance: all men will have medical clearance to participate in the study from a board certified internist, primary care physician, or cardiologist (for men with ongoing cardiovascular disease) prior to inclusion in the study; all participants' treating oncologists will also provide consent for participation prior to inclusion in the study
排除标准
- 未提供
结局指标
主要结局
Change in FL as measured by the abbreviated Late-Life Function, Disability Inventory (LL-FDI), and Mobility-Related Self-Efficacy
时间窗: Baseline to up to 3 months
Exploratory analyses of the direct and indirect pathways of the intervention effects on change in FL will be conducted using a structural equation modeling longitudinal panel model approach.
Change in functional performance assessed using the 400 meter walk, stair-climb, and lift and carry task
时间窗: Baseline to up to 3 months
Change in muscular strength, assessed using standardized one-repetition maximum testing protocols for chest press and leg extension exercises
时间窗: Baseline to up to 3 months
Change in body composition, assessed using the Bod Pod whole-body air displacement plethysmography system and GE Lunar dual-energy X-ray absorptiometry (iDXA) system
时间窗: Baseline to up to 3 months
Change in physical activity assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS), Leisure-Time Exercise Questionnaires, and LIFECORDER Plus Accelerometer
时间窗: Baseline to up to 3 months
Change in body weight, measured using a calibrated and certified balance beam scale
时间窗: Baseline to up to 3 months
Change in global and disease-specific QOL assessed using the Satisfaction with Life Scale, the Short Form (SF)-36, and the Functional Assessment of Cancer Treatment-Prostate (FACT-P)
时间窗: Baseline to up to 3 months
Exploratory analyses of the direct and indirect pathways of the intervention effects on change in QOL will be conducted using a structural equation modeling longitudinal panel model approach.
Change in pain and fatigue, assessed using the short-form McGill Pain Questionnaire and the Brief Fatigue Inventory (BFI)
时间窗: Baseline to up to 3 months
Change in exercise-related self-efficacy, assessed using Exercise Self-Efficacy, Barrier Self-Efficacy, Multi-dimensional, and Self-Regulatory Self-Efficacy scales
时间窗: Baseline to up to 3 months
Change in dietary behavior using the Fred Hutchinson Food Frequency Questionnaire and three-day diet records
时间窗: Baseline to up to 3 months
Feasibility of delivering an intensive lifestyle exercise and dietary intervention, assessed using recruitment rates, intervention adherence, adverse events, and retention rates
时间窗: Up to 3 months
Descriptive statistics will be calculated prospectively throughout the trial.
次要结局
未报告次要终点