Online weight loss and exercise program for prostate cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of an internet-based lifestyle intervention (iLIVE) designed to reduce obesity and frailty in men with prostate cancer who have undergone androgen deprivation therapy (ADT). Participants are randomized into two groups: one receiving the iLIVE program, which includes online weight loss resources and group resistance training, and the other receiving usual care with access to general exercise recommendations. The study aims to assess changes in health behaviors, physical functioning, and quality of life over a six-month period. Additionally, it seeks to identify barriers and facilitators to implementing the iLIVE program in clinical settings.

Why it matters

Who can join: the full rules

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's running

• OHSU Knight Cancer Institute
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Kerri Winters-Stone, PhD — OHSU Knight Cancer Institute
• Study coordinator: Carolyn Guidarelli, MPH
• Email: borsch@ohsu.edu
• Phone: 503-346-0307

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GET FIT Together: a socially enhanced exercise program for older men with prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.