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

NCT06011499 | Recruiting

• 3 other identifiers: STUDY00025281R01CA275055NCI-2023-03141
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (6)

• Change in overweight/obesity

  Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Overweight is defined as body mass index \> 25 kg/m\^2 and a 5% loss will be viewed as a successful outcome.

  At baseline, 3 months, 6 months and 12 months

• Change in sarcopenia

  Measured by 30 mg D3 creatine (D3Cr) capsule which they will ingest and then urinate on a test strip on the second void upon waking 3-6 days later. The enrichment of D3Cr will be measured from the test strip along with urine creatine and creatinine. Will use a cutoff of \< 10.75 kg/m\^2 (moderate sarcopenia).

  At baseline and 6 months

• Change in slowness

  Measured by the fastest time of two 4m walks at a usual pace administered by study staff by remote teleconference. Will use a cut point for "slowness" in older men of speed \< 1.0 m/s - a clinically meaningful cutoff that predicts falls and loss of independence.

  At baseline, 3 months and 6 months

• Change in weakness

  Measured by the seconds required to rise from a chair five times, administered by study staff by remote teleconference. Chair stand time \> 12 seconds predicts a 2.4 increased risk of falls in older adults and we will apply this cutoff for "weakness."

  At baseline, 3 months, and 6 months

• Change in inactivity

  Measured by physical activity-related energy expenditure, calculated from self-report on the 41-item Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire. We will use \< 383 kcals per week spent in moderate-vigorous intensity activity as our low activity cut point. Measured also by Fitbit.

  At baseline, 3 months, 6 months, and 12 months

• Change in frailty

  Measured using the 4-item short form (SF)-36 Vitality Scale. Will use cut points of scores of \< 50.00 (normed) for prostate cancer survivors (PCS) aged 50-64 years or scores less than 40.00 (normed) for PCS aged 65+ years.

  At baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (3)

• Change in health behaviors

  At baseline, 3 months, 6 months, and 12 months

• Change in physical functioning

  At baseline, 3 months, 6 months, 12 months

• Change in quality of life

  At baseline, 3 months, 6 months, and 12 months

Study Arms (2)

Arm I (iLIVE)

EXPERIMENTAL

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 smart scale while on study.

Other: Internet-Based Exercise Intervention; Other: Internet-Based Diet Intervention

Arm II (usual care)

ACTIVE COMPARATOR

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.

Other: Education Intervention

Interventions

Internet-Based Exercise Intervention OTHER

Participate in online supervised, group resistance training sessions (iLIVE)

Arm I (iLIVE)

Internet-Based Diet Intervention OTHER

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)

Arm I (iLIVE)

Education Intervention OTHER

Receive usual care receiving educational information about diet and exercise for cancer survivors

Arm II (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• INTERVENTION PARTICIPANTS: Age 18 or older
• INTERVENTION PARTICIPANTS: Diagnosed with histologically confirmed prostate cancer
• INTERVENTION PARTICIPANTS: Received \&gt;= 6 months of ADT any time in the past 10 years
• INTERVENTION PARTICIPANTS: Completed radiotherapy, chemotherapy and/or surgery \&gt; 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 \&gt; 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

You may not qualify if:

• INTERVENTION PARTICIPANTS: Unintentional weight loss \&gt; 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Oregon Health and Science University: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama

Birmingham, Alabama, 35294, United States

NOT YET RECRUITING

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Kerri Winters-Stone

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Guidarelli, MPH

CONTACT

503-346-0307; borsch@ohsu.edu

Sharon McCoy, MS

CONTACT

503-494-1676; mccoys@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors are blinded to participant group assignment after completing the baseline assessment and prior to randomization. Adverse events will be reviewed on a quarterly basis by the research team in a blinded fashion
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: March 12, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months following final publication
• Access Criteria: Access will be provided to investigators who provide a methodologically sound proposal and complete a data sharing agreement that includes commitments to: (1) using the data only for research purposes and not to identify any individual participant, (2) securing the data using appropriate computer technology, and (3) destroying or returning the data after analyses are completed. Proposals should be directed to wintersk@ohsu.edu. To gain access to data, data requestors will need to sign a data sharing agreement.

Locations

US (2)