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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - INTERVENTION PARTICIPANTS: Age 18 or older - INTERVENTION PARTICIPANTS: Diagnosed with diagnosed by tissue sample (biopsy-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 willing to sign a consent form - IMPLEMENTATION PARTICIPANTS: Be a key stakeholder (i.e., healthcare provider or administrative, or intervention participant \[completers, partial completers, or no participation\]) - IMPLEMENTATION PARTICIPANTS: Verbal willing to sign a consent form following receipt of an information sheet Who Should NOT Join This Trial: - 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 * 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 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

Treatments Being Tested

OTHER

Internet-Based Exercise Intervention

Participate in online supervised, group resistance training sessions (iLIVE)

OTHER

Internet-Based Diet Intervention

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)

OTHER

Education Intervention

Receive usual care receiving educational information about diet and exercise for cancer survivors

Locations (2)

University of Alabama
Birmingham, Alabama, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States