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

Primary Purpose

Prostate Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Internet-Based Intervention
Internet-Based Intervention
Interview
Survey Administration
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Carcinoma

Eligibility Criteria

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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: Obese but not class III morbidly obese (Body mass index [BMI] > 30 kg/m^2 to BMI < 50) INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the following frailty criteria: weakness, slowness, fatigue, inactivity, and/or unexpected weight loss INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or 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 review of an information sheet Exclusion Criteria: 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

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm I (iLIVE)

Arm II (Usual care)

Arm III (Interview)

Arm Description

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 smart scale while on study.

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.

Key stakeholders complete an interview while on study.

Outcomes

Primary Outcome Measures

Change in obesity
Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Obesity is defined as body mass index > 30kg/m^2 and a 5% loss will be viewed as a successful outcome.
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).
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.
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."
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 21, 2023
Last Updated
August 21, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University, University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT06011499
Brief Title
Internet-Based Lifestyle Intervention (iLIVE) to Eradicate Obese Frailty in Prostate Cancer Survivors
Acronym
iLIVE
Official Title
Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University, University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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 OBJECTIVE: I. To grasp iLIVE's implementation context and outcomes. OUTLINE: Patients are randomized to arm I or II. Key stakeholders are assigned to arm III. 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. ARM III: Key stakeholders complete an interview while on study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Adverse events will be reviewed on a quarterly basis by the research team in a blinded fashion
Allocation
Randomized
Enrollment
255 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (iLIVE)
Arm Type
Experimental
Arm Description
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 smart scale while on study.
Arm Title
Arm II (Usual care)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm III (Interview)
Arm Type
Experimental
Arm Description
Key stakeholders complete an interview while on study.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Participate in online group based resistance training sessions
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive usual care with online access to survivorship and exercise recommendation
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Complete an interview
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in obesity
Description
Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Obesity is defined as body mass index > 30kg/m^2 and a 5% loss will be viewed as a successful outcome.
Time Frame
At baseline, 3 months, 6 months and 12 months
Title
Change in sarcopenia
Description
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).
Time Frame
At baseline, 6 months, and 12 months
Title
Change in slowness
Description
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.
Time Frame
At baseline, 3 months, 6 months, and 12 months
Title
Change in weakness
Description
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."
Time Frame
At baseline, 3 months, 6 months, and 12 months
Title
Change in inactivity
Description
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.
Time Frame
At baseline, 3 months, 6 months, and 12 months
Title
Change in frailty
Description
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.
Time Frame
At baseline, 3 months, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
Change in health behaviors
Description
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.
Time Frame
At baseline, 3 months, 6 months, and 12 months
Title
Change in physical functioning
Description
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.
Time Frame
At baseline, 3 months, 6 months, 12 months
Title
Change in quality of life
Description
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.
Time Frame
At baseline, 3 months, 6 months, and 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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: Obese but not class III morbidly obese (Body mass index [BMI] > 30 kg/m^2 to BMI < 50) INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the following frailty criteria: weakness, slowness, fatigue, inactivity, and/or unexpected weight loss INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or 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 review of an information sheet Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Winters-Stone
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerri Winters-Stone
Phone
503-494-0813
Email
wintersk@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Kerri Winters-Stone

12. IPD Sharing Statement

Learn more about this trial

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

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