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Recruiting NCT06011499

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

No phase Interventional Prostate Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet-Based Exercise Intervention, Internet-Based Diet Intervention, Education Intervention.
Who it may be relevant to
Registry conditions: Prostate Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

PRIMARY OBJECTIVE:

I. To test the effectiveness of a combined online weight loss plus resistance training intervention (iLIVE) on obese frailty in prostate cancer survivors (PCS) on ADT.

SECONDARY OBJECTIVES:

I. To understand the effect of iLIVE on health behaviors, physical functioning, and quality of life II. To understand facilitators and barriers to implementing iLIVE in clinical and community practice

OUTLINE: Patients are randomized to arm I or II. Key stakeholders are identified for implementation outcomes

ARM I: Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.

ARM II: Patients receive usual care with access to online survivorship and exercise recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.

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.

Interventions

  • 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

Primary outcome measures

  • Change in overweight/obesity [Time frame: At baseline, 3 months, 6 months and 12 months]
  • Change in sarcopenia [Time frame: At baseline and 6 months]
  • Change in slowness [Time frame: At baseline, 3 months and 6 months]
  • Change in weakness [Time frame: At baseline, 3 months, and 6 months]
  • Change in inactivity [Time frame: At baseline, 3 months, 6 months, and 12 months]
  • Change in fatigue [Time frame: At baseline, 3 months, 6 months, and 12 months]
Secondary outcome measures (3)
  • Change in health behaviors [Time frame: At baseline, 3 months, 6 months, and 12 months]
  • Change in physical functioning [Time frame: At baseline, 3 months, 6 months, 12 months]
  • Change in quality of life [Time frame: At baseline, 3 months, 6 months, and 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • OHSU Knight Cancer Institute — Portland

Publications

  • Demark-Wahnefried W, Rogers LQ, Zubkoff L, Pisu M, Hung A, Graff JN, Hamilton J, Dieckmann NF, Winters-Stone K. Protocol for the internet-based lifestyle intervention to eradicate obese frailty in prostate cancer survivors (iLIVE) randomized controlled trial: a type I hybrid effectiveness implementation trial. BMC Cancer. 2026 Mar 25;26(1):559. doi: 10.1186/s12885-026-15851-4. PMID 41882641

Identifiers

NCT: NCT06011499 · STUDY00025281 · R01CA275055 · NCI-2023-03141 · STUDY00025281

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗