Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Behavioral: CLIPP
- Registration Number
- NCT04000464
- Lead Sponsor
- University of Arizona
- Brief Summary
This study is an investigator initiated clinical study. A prospective, single arm unblinded, open label study will be carried out to determine the feasibility of recruitment, retention and adherence of 30 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.
- Detailed Description
Introduction
* Androgen deprivation therapy (ADT) has been demonstrated to improve disease free and over-all survival in men with prostate cancer (PCa).
* ADT for PCa is associated with adverse cardio-metabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. This reduces quality of life (QoL) and potentially affects mortality.
* There is paucity of data regarding comprehensive lifestyle interventions in men on ADT for Pca. Existing studies used non-standardized interventions or lack data on metabolic risk factors.
* CLIPP is designed to address these gaps by using an intervention modelled after the Diabetes Prevention Program (DPP), a standardized multi-component intervention with demonstrated effectiveness in reducing diabetes risk factors that has been successfully adapted for multiple disease types including breast cancer.
Intervention:
* 24 Weeks
* Health Coaching Weekly
* Serum \& Urine Baseline, Week 12 and Week 24
* Anthropometric Measures
* Questionnaires
* Dual-energy X-ray absorptiometry (DXA) at Baseline and Week 24
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 31
- Diagnosed with prostate cancer Stage I, II or IV
- On androgen deprivation therapy with last 5 years
- Willing to participate in a lifestyle modification program
- Willing to modify diet and eating practices
- Willing to participate in blood collection, urine collection and measurements
- Minimum of 30 days since participating in another study/trial
- English speaking
- 40 years of age or older
- Currently participating in another study or trial
- Currently in hospice
- Inability to walk two city blocks
- Inability to comprehend informed consent or procedural requirements
- Digestive Diseases (IBD, Diverticulitis, etc) that might prevent him from increasing fruit and vegetable intake
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm CLIPP 24 Week Lifestyle Modification intervention
- Primary Outcome Measures
Name Time Method Reach Recruiting Target 6 Months Recruit 30 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.
Retention of Participants 6 months 80% retention rate, or 24 out of 30 participants
Adherence to Intervention 6 months 75% attendance rate throughout 24 intervention visits
- Secondary Outcome Measures
Name Time Method Hemoglobin A1c 6 Months Unit of Measure %
Lipid Panel 6 Months Unit of Measure Mg/dL
Specific Quality of Life Questionnaire 6 Months Expanded Prostate Cancer Index Composite Short Form (EPIC-26) - Scale of Measurement 0 to 4. 0=No Problem 1=Very Small problem 2=Small Problem 3=Moderate problem 4=Big Problem
Global Quality of Life Questionnaire 6 Months PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5. 1=Poor 2=Fair 3=Good 4=Very Good 5= Excellent
Fasting Glucose 6 Months Unit of Measure Mg/dL
Trial Locations
- Locations (1)
University of Arizona School of Medicine Collaboratory
🇺🇸Tucson, Arizona, United States