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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests iLIVE, an online weight loss and strength training program. It is for men with prostate cancer who had androgen deprivation therapy (ADT), a treatment that lowers male hormones. The study will see if the program helps reduce excess weight and frailty, which means being weak or less able to stay 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For the online program: Be age 18 or older and have prostate cancer confirmed by a tissue test.
  • Have had at least 6 months of ADT in the past 10 years.
  • Have finished radiation, chemotherapy, or surgery more than 6 weeks earlier. Have no plans to start added chemotherapy or radiation within 6 months of joining.
  • Be overweight or obese, with a body mass index (BMI, a measure based on height and weight) above 25 and no higher than 50.
  • Have at least 3 signs of frailty: weakness, slow movement, tiredness, lack of activity, or illness.
  • Not be in a structured diet or strength training program. Have home internet that supports video calls.
  • Agree to be assigned by chance to either study group, follow study rules, and sign a consent form.
  • For the part about putting the program into practice: Be a healthcare provider, administrator, or program participant, including those who finished, partly finished, or did not participate. Read an information sheet and give spoken consent.

Who can't join

  • For the online program: Lost more than 5% of your weight without trying in the past year.
  • Have a condition that makes moderate exercise unsafe.
  • Have a health condition that affects weight or body fat and muscle, such as Cushing’s syndrome or uncontrolled thyroid disease.
  • Have active cancer, other than non-melanoma skin cancer.
  • Cannot speak and understand English well enough to answer surveys, follow exercise or testing directions, and give consent in English.
  • Take creatine supplements now or took them in the month before the starting creatine test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

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