Prostate CarcinomaiLIVENCT06011499
Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE
A study testing Internet-Based Exercise Intervention, Internet-Based Diet Intervention and Education Intervention in people with Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Internet-Based Exercise Intervention, Internet-Based Diet Intervention and Education Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Kerri Winters-Stone, 503-494-0813, wintersk@ohsu.edu
Kerri Winters-Stone
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Internet-Based Exercise Intervention, Internet-Based Diet Intervention, Education Intervention
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based Exercise InterventionOther
Participate in online supervised, group resistance training sessions (iLIVE)
Internet-Based Diet InterventionOther
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 InterventionOther
Receive usual care receiving educational information about diet and exercise for cancer survivors
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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."
Measured: 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.
Measured: At baseline, 3 months, 6 months, and 12 months
Change in fatigue
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.
Measured: At baseline, 3 months, 6 months, and 12 months
Secondary outcomes (3)
Change in health behaviors
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.
Measured: At baseline, 3 months, 6 months, and 12 months
Change in physical functioning
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.
Measured: At baseline, 3 months, 6 months, 12 months
Change in quality of life
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.
Measured: At baseline, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start12 Mar 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Kerri Winters, OHSU Knight Cancer Institute
- Investigators
- Kerri Winters-Stone, PhD, Principal investigator, OHSU Knight Cancer InstituteWendy Demark-Wahnefried, PhD, RD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011499
- Sponsor's protocol ID
- STUDY00025281
- Other IDs
- R01CA275055, NCI-2023-03141, STUDY00025281
- Acronym
- iLIVE
- Status last verified
- May 2026
- First submitted
- 21 Aug 2023
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual quantitative participant data collected during the trial, after deidentification.
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.
PubMed 41882641
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)
- ClinicalTrials.gov ID
- NCT06011499
- Acronym / sponsor ID
- iLIVE / STUDY00025281
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University, University of Alabama at Birmingham
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (iLIVE) | Experimental | Other: Internet-Based Exercise Intervention, Other: Internet-Based Diet InterventionPatients 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. |
| Arm II (usual care) | Active comparator | Other: Education InterventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based Exercise InterventionParticipate in online supervised, group resistance training sessions (iLIVE) | Other | Arm I (iLIVE) |
| Internet-Based Diet InterventionReceive 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 | Arm I (iLIVE) |
| Education InterventionReceive usual care receiving educational information about diet and exercise for cancer survivors | Other | Arm II (usual care) |
Primary outcome
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.
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).
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.
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."
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 41882641Demark-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.
- Individual participant dataSharing planned: Yes. All individual quantitative participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerri Winters-Stone, PhD principal investigator
OHSU Knight Cancer Institute
Wendy Demark-Wahnefried, PhD, RD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Exercise Intervention, Internet-Based Diet Intervention and Education Intervention in people with Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Guidarelli, MPH (503-346-0307, borsch@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overweight/obesity (time frame: At baseline, 3 months, 6 months and 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06011499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.