RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-02
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06011499

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * INTERVENTION PARTICIPANTS: Age 18 or older
  2. * INTERVENTION PARTICIPANTS: Diagnosed with histologically confirmed prostate cancer
  3. * INTERVENTION PARTICIPANTS: Received \>= 6 months of ADT any time in the past 10 years
  4. * INTERVENTION PARTICIPANTS: Completed radiotherapy, chemotherapy and/or surgery \> 6 weeks prior to
  5. * INTERVENTION PARTICIPANTS: No intent to start adjuvant chemotherapy or radiotherapy within 6 months of enrollment
  6. * INTERVENTION PARTICIPANTS: Overweight or obese (BMI \> 25 kg/m2 to BMI ≤ 50).
  7. * INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the following frailty criteria: weakness, slowness, fatigue, inactivity, and/or illness
  8. * INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or resistance strength training exercise program
  9. * INTERVENTION PARTICIPANTS: Willing to be randomized into either study arm and adhere to study protocol
  10. * INTERVENTION PARTICIPANTS: Home internet sufficient for videoconferencing
  11. * INTERVENTION PARTICIPANTS: Signed informed consent
  12. * IMPLEMENTATION PARTICIPANTS: Be a key stakeholder (i.e., healthcare provider or administrative, or intervention participant \[completers, partial completers, or no participation\])
  13. * IMPLEMENTATION PARTICIPANTS: Verbal informed consent following receipt of an information sheet
  1. * INTERVENTION PARTICIPANTS: Unintentional weight loss \> 5% within the last year
  2. * INTERVENTION PARTICIPANTS: Contraindication to moderate intensity exercise
  3. * INTERVENTION PARTICIPANTS: Health or medical condition that affects weight status/body composition (e.g., Cushing's syndrome, uncontrolled hyper-/hypo- thyroidism)
  4. * INTERVENTION PARTICIPANTS: Active malignancy (other than non-melanoma skin cancer)
  5. * 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

Contacts and Locations

Study Contact

Carolyn Guidarelli, MPH
CONTACT
503-346-0307
borsch@ohsu.edu
Sharon McCoy, MS
CONTACT
503-494-1676
mccoys@ohsu.edu

Principal Investigator

Kerri Winters-Stone
PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35294
United States
OHSU Knight Cancer Institute
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: OHSU Knight Cancer Institute

  • Kerri Winters-Stone, PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-02
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-04-02
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Carcinoma