Clinical trial NCT06011499: Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE
Official title: Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Oregon Health and Science University
name: University of Alabama at Birmingham
First posted: 2023-08-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in overweight/obesity
timeFrame: At baseline, 3 months, 6 months and 12 months
measure: Change in sarcopenia
timeFrame: At baseline and 6 months
measure: Change in slowness
timeFrame: At baseline, 3 months and 6 months
measure: Change in weakness
timeFrame: At baseline, 3 months, and 6 months
measure: Change in inactivity
timeFrame: At baseline, 3 months, 6 months, and 12 months
measure: Change in frailty
timeFrame: At baseline, 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Change in health behaviors
timeFrame: At baseline, 3 months, 6 months, and 12 months
measure: Change in physical functioning
timeFrame: At baseline, 3 months, 6 months, 12 months
measure: Change in quality of life
timeFrame: At baseline, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kerri Winters-Stone
role: PRINCIPAL_INVESTIGATOR
References: