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.
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 ARM I: 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 (registered trademark) smart scale while on study. ARM II: 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. Patients are followed for 6 months after completion of intervention. Key stakeholders complete an interview while on study to assess barriers and facilitators to implementation of iLIVE into clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
250
Participate in online supervised, group resistance training sessions (iLIVE)
Receive online access to an interactive website with a series of weekly self-directed and interactive sessions on various topics associated with diet and weight loss (iLIVE)
Receive usual care receiving educational information about diet and exercise for cancer survivors
University of Alabama
Birmingham, Alabama, United States
NOT_YET_RECRUITINGOHSU Knight Cancer Institute
Portland, Oregon, United States
RECRUITINGChange in overweight/obesity
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.
Time frame: At baseline, 3 months, 6 months and 12 months
Change in sarcopenia
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).
Time frame: At baseline and 6 months
Change in slowness
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.
Time frame: At baseline, 3 months and 6 months
Change in weakness
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."
Time frame: At baseline, 3 months, and 6 months
Change in inactivity
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.
Time frame: At baseline, 3 months, 6 months, and 12 months
Change in frailty
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.
Time frame: At baseline, 3 months, 6 months, and 12 months
Change in health behaviors
Dietary intake measured using a 2-day diet recalls of 1-weekday and 1 weekend day will be collected by a registered dietitian via telephone and entered into the National Cancer Institute-developed Automated Self-Administered 24-hour. Physical activity measured using CHAMPS as described above. We will also assess free-living physical activity over 7-days using Fitbits.
Time frame: At baseline, 3 months, 6 months, and 12 months
Change in physical functioning
Measured by Timed Up and Go using a widely used clinical measure of functional mobility that evaluates the time it takes to rise from a chair, walk 3m, turn around, and return and sit in the chair. SF-36 Physical Function measured using a 10-item physical function subscale of the SF-36.
Time frame: At baseline, 3 months, 6 months, 12 months
Change in quality of life
Measured by European Quality of Life-5D with 1 question in 5 separate domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Scores will also be used to calculate Quality of Life Adjusted Years for cost-effectiveness analysis. Healthcare utilization measured using a brief questionnaire that assesses physician and emergency room visits, hospitalizations, etc.
Time frame: At baseline, 3 months, 6 months, and 12 months
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