Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer

NCT04000464 | Completed

• 1 other identifier: 1806697620
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Reach Recruiting Target

  Recruit 30 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.

  6 Months

• Retention of Participants

  80% retention rate, or 24 out of 30 participants

  6 months

• Adherence to Intervention

  75% attendance rate throughout 24 intervention visits

  6 months

Secondary Outcomes (5)

• Fasting Glucose

  6 Months

• Lipid Panel

  6 Months

• Hemoglobin A1c

  6 Months

• Global Quality of Life Questionnaire

  6 Months

• Specific Quality of Life Questionnaire

  6 Months

Other Outcomes (2)

• Inflammatory pathways associated with Prostate Cancer Progression.

  6 Months

• Angiogenic pathways associated with prostate cancer progression

  6 Months

Study Arms (1)

Single Arm

EXPERIMENTAL

24 Week Lifestyle Modification intervention

Behavioral: CLIPP

Interventions

CLIPP BEHAVIORAL

Diabetes Prevention program and Comprehensive Lifestyle Improvement Program consisting of low calorie diet, physical activity, sleep optimization and stress management

Single Arm

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of Arizona School of Medicine Collaboratory

Tucson, Arizona, 85714, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Amit Algotar, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre and Post study model

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: June 27, 2019
• Study Start: October 9, 2018
• Primary Completion: December 19, 2019
• Study Completion: December 30, 2019
• Last Updated: January 14, 2020

Record last verified: 2019-11

Locations

US (1)