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NCT Number: NCT06011499

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

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.

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Kerri Winters-Stone

CONTACT

[email protected]

503-494-0813

Kerri Winters-Stone

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-Based Exercise Intervention

Other

Participate in online supervised, group resistance training sessions (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)

Education Intervention

Other

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

Primary outcomes

  1. Change in overweight/obesity

    Time frame: At baseline, 3 months, 6 months and 12 months

    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.

  2. Change in sarcopenia

    Time frame: At baseline and 6 months

    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).

  3. Change in slowness

    Time frame: At baseline, 3 months and 6 months

    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.

  4. Change in weakness

    Time frame: At baseline, 3 months, and 6 months

    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."

  5. Change in inactivity

    Time frame: At baseline, 3 months, 6 months, and 12 months

    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.

  6. Change in fatigue

    Time frame: At baseline, 3 months, 6 months, and 12 months

    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.

Secondary outcomes

  1. Change in health behaviors

    Time frame: At baseline, 3 months, 6 months, and 12 months

    Dietary intake measured using a 2-day diet recalls of 1-weekday and 1 weekend day will be collected by a registered dietitian via telephone and entered into the National Cancer Institute-developed Automated Self-Administered 24-hour. Physical activity measured using CHAMPS as described above. We will also assess free-living physical activity over 7-days using Fitbits.

  2. Change in physical functioning

    Time frame: At baseline, 3 months, 6 months, 12 months

    Measured by Timed Up and Go using a widely used clinical measure of functional mobility that evaluates the time it takes to rise from a chair, walk 3m, turn around, and return and sit in the chair. SF-36 Physical Function measured using a 10-item physical function subscale of the SF-36.

  3. Change in quality of life

    Time frame: At baseline, 3 months, 6 months, and 12 months

    Measured by European Quality of Life-5D with 1 question in 5 separate domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Scores will also be used to calculate Quality of Life Adjusted Years for cost-effectiveness analysis. Healthcare utilization measured using a brief questionnaire that assesses physician and emergency room visits, hospitalizations, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn Guidarelli, MPH

CONTACT

[email protected]

503-346-0307

Sharon McCoy, MS

CONTACT

[email protected]

503-494-1676

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • Oregon Health and Science University
  • University of Alabama at Birmingham

Registry information

Official study title

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

Acronym: iLIVE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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