Internet-Based Lifestyle Intervention (iLIVE) to Eradicate Obese Frailty in Prostate Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)

Conditions
-----------------
Prostate Carcinoma

Intervention / Treatment
-----------------
* Other: Internet-Based Exercise Intervention
* Other: Internet-Based Diet Intervention
* Other: Education Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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: Overweight but not class III morbidly obese (Body mass index [BMI] > 25 kg/m^2 to BMI < 50) INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the following frailty criteria: weakness, slowness, fatigue, inactivity, and/or unexpected weight loss INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or 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 review of an information sheet Exclusion Criteria: 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (iLIVE)<br>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 smart scale while on study. | Other: Internet-Based Exercise Intervention<br>* Participate in online supervised, group resistance training sessions (iLIVE)<br>Other: Internet-Based Diet Intervention<br>* 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)<br>|
| Active Comparator: Arm II (Usual care)<br>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. | Other: Education Intervention<br>* Receive usual care receiving educational information about diet and exercise for cancer survivors<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. A 5% loss will be viewed as a successful outcome. | 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). | At baseline, 6 months, and 12 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. | At baseline, 3 months, 6 months, and 12 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. | At baseline, 3 months, 6 months, and 12 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. | 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. | At baseline, 3 months, 6 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | At baseline, 3 months, 6 months, and 12 months |