Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Change in frailty
研究概览
简要总结
This clinical trial tests the effectiveness of an online weight loss plus resistance training intervention (iLIVE) to decrease obesity and improve frailty in men with prostate cancer who received androgen deprivation therapy (ADT). Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty and obesity can lead to a decrease in quality of life and an increased risk of recurrent falls. Using iLIVE may improve obesity and frailty in men with prostate cancer who receive ADT.
详细描述
PRIMARY OBJECTIVE:
I. To test the effectiveness of a combined online weight loss plus resistance training intervention (iLIVE) on obese frailty in prostate cancer survivors (PCS) on ADT.
SECONDARY OBJECTIVES:
I. To understand the effect of iLIVE on health behaviors, physical functioning, and quality of life II. To understand facilitators and barriers to implementing iLIVE in clinical and community practice
OUTLINE: Patients are randomized to arm I or II. Key stakeholders are identified for implementation outcomes
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 (Outcomes Assessor)
盲法说明
Outcomes assessors are blinded to participant group assignment after completing the baseline assessment and prior to randomization. Adverse events will be reviewed on a quarterly basis by the research team in a blinded fashion
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INTERVENTION PARTICIPANTS: Age 18 or older
- •INTERVENTION PARTICIPANTS: Diagnosed with histologically confirmed prostate cancer
- •INTERVENTION PARTICIPANTS: Received >= 6 months of ADT any time in the past 10 years
- •INTERVENTION PARTICIPANTS: Completed radiotherapy, chemotherapy and/or surgery > 6 weeks prior to
- •INTERVENTION PARTICIPANTS: No intent to start adjuvant chemotherapy or radiotherapy within 6 months of enrollment
- •INTERVENTION PARTICIPANTS: Overweight or obese (body mass index > 25 kg/m2 to BMI ≤ 50).
- •INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the following frailty criteria: weakness, slowness, fatigue, inactivity, and/or illness
- •INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or resistance strength training exercise program
- •INTERVENTION PARTICIPANTS: Willing to be randomized into either study arm and adhere to study protocol
- •INTERVENTION PARTICIPANTS: Home internet sufficient for videoconferencing
- •INTERVENTION PARTICIPANTS: Signed informed consent
- •IMPLEMENTATION PARTICIPANTS: Be a key stakeholder (i.e., healthcare provider or administrative, or intervention participant [completers, partial completers, or no participation])
- •IMPLEMENTATION PARTICIPANTS: Verbal informed consent following receipt of an information sheet
排除标准
- •INTERVENTION PARTICIPANTS: Unintentional weight loss > 5% within the last year
- •INTERVENTION PARTICIPANTS: Contraindication to moderate intensity exercise
- •INTERVENTION PARTICIPANTS: Health or medical condition that affects weight status/body composition (e.g., Cushing's syndrome, uncontrolled hyper-/hypo- thyroidism)
- •INTERVENTION PARTICIPANTS: Active malignancy (other than non-melanoma skin cancer)
- •INTERVENTION PARTICIPANTS: Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English
- •INTERVENTION PARTICIPANTS: Currently taking or have taken creatine supplement in the month preceding baseline creatine testing
研究组 & 干预措施
Arm I (iLIVE)
Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria smart scale while on study.
干预措施: Internet-Based Exercise Intervention (Other)
Arm I (iLIVE)
Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria smart scale while on study.
干预措施: Internet-Based Diet Intervention (Other)
Arm II (usual care)
Patients receive usual care with access to online survivorship and exercise recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.
干预措施: Education Intervention (Other)
结局指标
主要结局
Change in frailty
时间窗: At baseline, 3 months, 6 months, and 12 months
Measured using the 4-item short form (SF)-36 Vitality Scale. Will use cut points of scores of \< 50.00 (normed) for prostate cancer survivors (PCS) aged 50-64 years or scores less than 40.00 (normed) for PCS aged 65+ years.
Change in overweight/obesity
时间窗: At baseline, 3 months, 6 months and 12 months
Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Overweight is defined as body mass index \> 25 kg/m\^2 and a 5% loss will be viewed as a successful outcome.
Change in sarcopenia
时间窗: At baseline and 6 months
Measured by 30 mg D3 creatine (D3Cr) capsule which they will ingest and then urinate on a test strip on the second void upon waking 3-6 days later. The enrichment of D3Cr will be measured from the test strip along with urine creatine and creatinine. Will use a cutoff of \< 10.75 kg/m\^2 (moderate sarcopenia).
Change in weakness
时间窗: At baseline, 3 months, and 6 months
Measured by the seconds required to rise from a chair five times, administered by study staff by remote teleconference. Chair stand time \> 12 seconds predicts a 2.4 increased risk of falls in older adults and we will apply this cutoff for "weakness."
Change in slowness
时间窗: At baseline, 3 months and 6 months
Measured by the fastest time of two 4m walks at a usual pace administered by study staff by remote teleconference. Will use a cut point for "slowness" in older men of speed \< 1.0 m/s - a clinically meaningful cutoff that predicts falls and loss of independence.
Change in inactivity
时间窗: At baseline, 3 months, 6 months, and 12 months
Measured by physical activity-related energy expenditure, calculated from self-report on the 41-item Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire. We will use \< 383 kcals per week spent in moderate-vigorous intensity activity as our low activity cut point. Measured also by Fitbit.
次要结局
- Change in health behaviors(At baseline, 3 months, 6 months, and 12 months)
- Change in physical functioning(At baseline, 3 months, 6 months, 12 months)
- Change in quality of life(At baseline, 3 months, 6 months, and 12 months)
研究者
Kerri Winters
Principal Investigator
OHSU Knight Cancer Institute