Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06011499

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionProstate Carcinoma

Full registry 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: 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

Treatments and study arms

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

Change in overweight/obesityAt 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 sarcopeniaAt 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 slownessAt 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 weaknessAt 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 inactivityAt 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 fatigueAt 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

OHSU Knight Cancer Institute🇺🇸 Portland, Oregon, United States

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Kerri Winters-StoneContact

Email · Call 503-494-0813

Kerri Winters-StonePrincipal Investigator