Online weight loss and exercise program for prostate cancer survivors
Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)
This study is testing an online weight loss and exercise program to see if it helps men with prostate cancer who have had hormone therapy feel healthier and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06011499 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 or older with a diagnosis of prostate cancer who have received androgen deprivation therapy and are overweight or obese.
Not a fit: Patients who are not overweight or obese, or those currently engaged in structured diet or resistance training programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and physical health of prostate cancer survivors by reducing obesity and frailty.
How similar studies have performed: Other studies have shown promise with similar lifestyle interventions for cancer survivors, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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: 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 this trial is running
Portland, Oregon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.