Eating, Activity, and Stress Education (EASE)
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ClinicalTrials.gov Identifier: NCT01434004 |
Recruitment Status
:
Completed
First Posted
: September 14, 2011
Last Update Posted
: April 9, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Behavioral: Lifestyle counseling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | A Diet, Physical Activity, and Meditation Intervention in Men With Rising Prostate-specific Antigen |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | July 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Lifestyle counseling
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
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. |
No Intervention: Control group
Usual care (watchful waiting).
|
- Change in prostate-specific antigen from baseline [ Time Frame: baseline, 3 months, 6 months ]PSA is measured at baseline, 3 months and 6 months. Change in PSA is the primary outcome measure.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)

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): NCT01434004
United States, South Carolina | |
Palmetto Baptist Medical Center | |
Columbia, South Carolina, United States, 29201 | |
Palmetto Richland Memorial Hospital | |
Columbia, South Carolina, United States, 29203 |
Principal Investigator: | James R Hebert, Sc.D. | University of South Carolina |
Responsible Party: | University of South Carolina |
ClinicalTrials.gov Identifier: | NCT01434004 History of Changes |
Other Study ID Numbers: |
DAMD17-03-1-0139 |
First Posted: | September 14, 2011 Key Record Dates |
Last Update Posted: | April 9, 2015 |
Last Verified: | April 2015 |
Keywords provided by University of South Carolina:
prostate cancer |
Additional relevant MeSH terms:
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |