Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE
Recruiting · NCT06011499 · Interventional (participants receive a specific treatment) · Lead sponsor: OHSU Knight Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Education InterventionInternet-Based Diet InterventionInternet-Based Exercise Intervention
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- OHSU Knight Cancer Institute - Portland, Oregon, United States