Eating, Activity, and Stress Education

NCT01434004 | Completed

• 1 other identifier: DAMD17-03-1-0139
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether a vegetable-based diet, physical activity program, and stress reduction training will reduce or maintain PSA levels, an indicator of prostate cancer progression, in men who have had their prostate gland removed following a prostate cancer diagnosis.

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

• Change in prostate-specific antigen from baseline

  PSA is measured at baseline, 3 months and 6 months. Change in PSA is the primary outcome measure.

  baseline, 3 months, 6 months

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Diet component: focus on increasing intake of whole grains, soybeans, soybean products, other beans, and vegetables. Physical Activity: encourage completion of morning exercise sessions. Mindfulness Stress Reduction: training in mindfulness meditation, including dealing with intensive physical symptoms and difficult emotional situations.

Behavioral: Lifestyle counseling

Control group

NO INTERVENTION

Usual care (watchful waiting).

Interventions

Lifestyle counseling BEHAVIORAL

Diet component: focus on increasing intake of whole grains, soybeans, soybean products, other beans, and vegetables. Physical Activity: encourage completion of morning exercise sessions. Mindfulness Stress Reduction: training in mindfulness meditation, including dealing with intensive physical symptoms and difficult emotional situations.

Lifestyle counseling

Eligibility Criteria

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

You may qualify if:

• have a histologically confirmed diagnosis of adenocarcinoma of the prostate
• have been treated by radical prostatectomy or radiation therapy
• have had no malignancy in the past 5 years (except the primary prostate cancer for which initial treatment was sought and non malignant melanoma of the skin)
• not be taking thyroid medication, antibiotics, diuretics or steroids
• be able to read at a sixth grade level
• speak English as their first language
• be of sound mind, memory, and understanding as evaluated by recruitment staff
• have experienced a rise in serum PSA concentration after achieving a post surgery nadir, after achieving a post radiation nadir, or having had both a radical prostatectomy and subsequent radiotherapy

You may not qualify if:

• has received high dose radiotherapy or brachytherapy in place of surgery as a primary treatment
• has received post-operative hormone therapy for prostate cancer
• received treatment of prostate cancer with an LH-RH analog
• has a diagnosis of cardiovascular, pulmonary, or metabolic disease or major symptoms of these diseases, including pain or discomfort in the chest, neck, jaw, arms or other areas that may be due to ischemia; shortness of breath or unusual fatigue at rest or with mild exertion; dizziness; dyspnea while sleeping; ankle edema or intermittent claudication; palpitations, tachycardia, or a known heart murmur
• has experienced a weight loss in excess of five pounds in the previous 3 months
• regularly consumes more than two alcoholic drinks per day
• plans on taking hormone supplements such as melatonin, or fish oil or other; supplements rich in omega-3 fatty acids
• has been diagnosed with Crohn's disease or has active ulcerative colitis
• has been diagnosed with Post Traumatic Stress Disorder (PTSD)

Sponsors & Collaborators

• University of South Carolina: lead
• United States Department of Defense: collaborator

Study Sites (2)

Palmetto Baptist Medical Center

Columbia, South Carolina, 29201, United States

Location

Palmetto Richland Memorial Hospital

Columbia, South Carolina, 29203, 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

• James R Hebert, Sc.D.

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 14, 2011
• Study Start: January 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (2)