EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression
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|ClinicalTrials.gov Identifier: NCT04266431|
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasm||Behavioral: EMPOWER||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eligible consented men will be stratified for randomization according to prostate specific antigen doubling time (PSADT; <6 months or 6-12 months) calculated using 3 values (≥1 week apart; ≤ 3 months from randomization; Memorial Sloan Kettering Cancer Center prediction tool: http://nomograms.mskcc.org/Prostate/PsaDoublingTime.aspx), and body mass index (BMI) at baseline (25 kg/m2 ≤BMI <30 kg/m2 or BMI≥ 30 kg/m2). Following stratification, men will be randomized 1:1 using a computer-generated, password protected randomization enrollment system by the biostatistician. Men will be informed of the random assignment after consenting to the study and completing the baseline questionnaires and blood collection. Study visits will take place at 6 months, 12 months, and 24 months after baseline.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The randomization scheme will be generated by the senior biostatistician, and access will be restricted for the duration of the trial. The participants and interventionists will not be blinded to study arm. The study staff involved in data collection, staff involved in laboratory measurements, and the biostatistician conducting the data analysis will be blinded to the random assignment.|
|Official Title:||EMPOWER Men to Reduce Weight and Inhibit Prostate Cancer Progression|
|Actual Study Start Date :||February 20, 2020|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2024|
EMPOWER is a multichannel, behavioral lifestyle intervention delivered remotely. The goals of EMPOWER are to induce a loss of 5% or more of initial weight within 6 months and to maintain these improvements at 12 and 24 months, by meeting dietary and physical activity goals. Coach-participant contacts will occur by phone and email, without in-person visits. Coaching contacts will be weekly for the first 12 weeks and then monthly thereafter. Men will have access to a web-based system that (1) provides support for behavioral methods of weight management and (2) allows coaches to review participant self-monitoring data and monitor participant progress towards goals. Men will record diet, exercise, and weight on the web or on a smart phone application.
Behavioral weight loss intervention
No Intervention: Standard of Care
Men randomized to the standard of care group will continue to receive treatment from the mens' medical oncologist. These men will also be provided with a one page informative brochure on lifestyle recommendations adapted from the American Cancer Society Prostate Cancer Survivorship Care Guidelines, at the time of randomization. At the end of the trial, men in this arm will be offered a one-time counseling session with an intervention coach on healthy lifestyle.
- Proportion of men who develop prostate specific antigen (PSA) progression or radiographic progression [ Time Frame: 12 months ]Proportion of men who develop prostate specific antigen (PSA) progression or radiographic progression (e.g. soft tissue or bone lesions). In accordance with the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression will be defined as an increase that is ≥25% and ≥2 ng/mL above the nadir that is confirmed by a second value in ≥3 weeks, soft tissue lesions will be defined using RECIST 1.1 criteria, and bone lesions will be defined as ≥2 new lesions, with a confirmatory scan ≥6 weeks later.
- Proportion of men who experience clinical progression [ Time Frame: Up to 24 months ]Proportion of men who experience clinical progression defined as development of (1) pain that, in the medical oncologist's opinion, is secondary to prostate cancer, or (2) a pathologic fracture or other skeletal event.
- PSA doubling time [ Time Frame: Up to 24 months ]PSA doubling time calculated using 3 values (≥1 week apart; Memorial Sloan Kettering Cancer Center prediction tool)
- Change in PSA [ Time Frame: 6 months, 12 months, and 24 months ]Change in PSA level (ng/mL).
- Change in weight [ Time Frame: 6 months, 12 months, and 24 months ]Weight measured by scale in kilograms (kg).
- Change in waist circumference [ Time Frame: 6 months, 12 months, and 24 months ]Waist circumference [in centimeters (cm)] using an anthropometric measuring tape at a horizontal plane that is one cm above the navel.
- Change in diet [ Time Frame: 6 months, 12 months, and 24 months ]Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
- Change in physical activity [ Time Frame: 6 months, 12 months, and 24 months ]Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266431
|Contact: Corinne Joshu, PhD||(443) firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Colburn Yu 443-287-6419 EMPOWERtrial@jhmi.edu|
|Principal Investigator:||Corinne Joshu, PhD||Johns Hopkins Bloomberg School of Public Health|