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.
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: 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)
Parallel
Internet-Based Exercise Intervention
Other interventionParticipate in online supervised, group resistance training sessions (iLIVE)
Internet-Based Diet Intervention
Other interventionReceive 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)
Education Intervention
Other interventionReceive usual care receiving educational information about diet and exercise for cancer survivors
Change 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.
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).
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.
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."
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.
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.
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.
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OHSU Knight Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Oregon Health and Science University
Collaborator
University of Alabama at Birmingham
Collaborator
