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Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE Trial
Trial Status: active
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.
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: Completed radiotherapy, chemotherapy and/or surgery ≥ 6 weeks prior to enrollment and no concurrent adjuvant therapy other than ADT for prostate cancer
INTERVENTION PARTICIPANTS: No intent to start adjuvant chemotherapy or radiotherapy within 6 months of enrollment
INTERVENTION PARTICIPANTS: Overweight or 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 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
Exclusion Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT06011499.
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 OBJECTIVE:
I. To grasp iLIVE’s implementation context and outcomes.
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.
