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Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer

Primary Purpose

Malnutrition, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nutritional support
quality-of-life assessment
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Malnutrition focused on measuring malnutrition, stage I prostate cancer, stage II B prostate cancer, stage II A prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosed with early stage prostate or breast (closed to accrual as of 8/1/03) cancer within the past 9 months Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Breast cancer (closed to accrual as of 8/1/03) patients must be female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No other malignancy within the past 5 years except nonmelanoma skin cancer Able to speak and write in English Performs insufficient exercise Maintains a high-fat, low-vegetable, low-fruit diet PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
February 21, 2017
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00044980
Brief Title
Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer
Official Title
Fresh Start: Promoting Health in Prostate Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: An individualized, computer-designed health program may promote changes in diet and physical activity and may improve quality of life in patients who have early-stage prostate cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of an individualized, computer-designed diet and exercise-based counseling program with that of a standard counseling program in promoting health in patients who have early-stage prostate cancer.
Detailed Description
OBJECTIVES: Compare the effectiveness of a computer-tailored, correspondence course vs standardized materials in promoting changes in diet and physical activity (PA) behaviors in patients with early stage prostate or breast (closed to accrual as of 8/1/03) cancer who currently do not practice goal behavior in at least 2 of the following 3 areas: performance of moderate PA for at least 150 minutes per week; consumption of at least 5 servings of vegetables or fruit daily; or consumption of a diet with less than 30% fat (with less than 10% of kilocalories from either saturates or polyunsaturates). Compare the health and quality of life of patients treated with these interventions. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients participate in a computer-tailored, correspondence course comprising personalized diet and exercise intervention and other health information over a 10-month period. Arm II: Patients receive usual care comprising standardized print materials related to diet, exercise, cancer, and other pertinent health issues over a 10-month period. In both arms, diet and exercise behavior, quality of life, co-morbidity status, depression, social support, worry, self efficacy, and coping style are assessed during phone interviews conducted at baseline, after completion of 10 months of study intervention, and then at 1 year. Intervention usefulness is assessed after completion of 10 months of study intervention. Patients in both arms who live within a 1-hour drive from Duke University Medical Center may undergo blood draw to test for substances related to fruit and vegetable intake and measurement of height and weight. Patients may also be asked to wear a pedometer for a 1-week period. PROJECTED ACCRUAL: A total of 530 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Prostate Cancer
Keywords
malnutrition, stage I prostate cancer, stage II B prostate cancer, stage II A prostate cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
nutritional support
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosed with early stage prostate or breast (closed to accrual as of 8/1/03) cancer within the past 9 months Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Breast cancer (closed to accrual as of 8/1/03) patients must be female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No other malignancy within the past 5 years except nonmelanoma skin cancer Able to speak and write in English Performs insufficient exercise Maintains a high-fat, low-vegetable, low-fruit diet PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Demark-Wahnefried, PhD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12618570
Citation
Demark-Wahnefried W, Clipp EC, McBride C, Lobach DF, Lipkus I, Peterson B, Clutter Snyder D, Sloane R, Arbanas J, Kraus WE. Design of FRESH START: a randomized trial of exercise and diet among cancer survivors. Med Sci Sports Exerc. 2003 Mar;35(3):415-24. doi: 10.1249/01.MSS.0000053704.28156.0F.
Results Reference
background
PubMed Identifier
16292046
Citation
Macri JM, Downs SM, Demark-Wahnefried W, Snyder DC, Lobach DF. A simple, flexible and scalable approach for generating tailored questionnaires and health education messages. Comput Inform Nurs. 2005 Nov-Dec;23(6):316-21. doi: 10.1097/00024665-200511000-00007.
Results Reference
background
PubMed Identifier
22117660
Citation
Christy SM, Mosher CE, Sloane R, Snyder DC, Lobach DF, Demark-Wahnefried W. Long-term dietary outcomes of the FRESH START intervention for breast and prostate cancer survivors. J Am Diet Assoc. 2011 Dec;111(12):1844-51. doi: 10.1016/j.jada.2011.09.013.
Results Reference
result
PubMed Identifier
21598023
Citation
Ottenbacher AJ, Day RS, Taylor WC, Sharma SV, Sloane R, Snyder DC, Kraus WE, Demark-Wahnefried W. Exercise among breast and prostate cancer survivors--what are their barriers? J Cancer Surviv. 2011 Dec;5(4):413-9. doi: 10.1007/s11764-011-0184-8. Epub 2011 May 20.
Results Reference
result
Citation
Demark-Wahnefried W, Clipp E, Lipkus I, et al.: Results of FRESH START: a randomized controlled trial to improve diet and exercise behaviors in breast and prostate cancer survivors. [Abstract] J Clin Oncol 24 (Suppl 18): A-8503, 468s, 2006.
Results Reference
result
PubMed Identifier
17602076
Citation
Demark-Wahnefried W, Clipp EC, Lipkus IM, Lobach D, Snyder DC, Sloane R, Peterson B, Macri JM, Rock CL, McBride CM, Kraus WE. Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors. J Clin Oncol. 2007 Jul 1;25(19):2709-18. doi: 10.1200/JCO.2007.10.7094.
Results Reference
result
PubMed Identifier
15389420
Citation
Snyder DC, Sloane R, Lobach D, Lipkus I, Clipp E, Kraus WE, Demark-Wahnefried W; Fresh Start study. Agreement between a brief mailed screener and an in-depth telephone survey: observations from the Fresh Start study. J Am Diet Assoc. 2004 Oct;104(10):1593-6. doi: 10.1016/j.jada.2004.07.024.
Results Reference
result
PubMed Identifier
18987083
Citation
Mosher CE, Lipkus IM, Sloane R, Kraus WE, Snyder DC, Peterson B, Jones LW, Demark-Wahnefried W. Cancer survivors' health worries and associations with lifestyle practices. J Health Psychol. 2008 Nov;13(8):1105-12. doi: 10.1177/1359105308095964.
Results Reference
result
PubMed Identifier
18300337
Citation
Mosher CE, Fuemmeler BF, Sloane R, Kraus WE, Lobach DF, Snyder DC, Demark-Wahnefried W. Change in self-efficacy partially mediates the effects of the FRESH START intervention on cancer survivors' dietary outcomes. Psychooncology. 2008 Oct;17(10):1014-23. doi: 10.1002/pon.1327.
Results Reference
result
PubMed Identifier
18483353
Citation
Snyder DC, Sloane R, Lobach D, Lipkus IM, Peterson B, Kraus W, Demark-Wahnefried W. Differences in baseline characteristics and outcomes at 1- and 2-year follow-up of cancer survivors accrued via self-referral versus cancer registry in the FRESH START Diet and exercise trial. Cancer Epidemiol Biomarkers Prev. 2008 May;17(5):1288-94. doi: 10.1158/1055-9965.EPI-07-0705.
Results Reference
result
PubMed Identifier
19461530
Citation
Sloane R, Snyder DC, Demark-Wahnefried W, Lobach D, Kraus WE. Comparing the 7-day physical activity recall with a triaxial accelerometer for measuring time in exercise. Med Sci Sports Exerc. 2009 Jun;41(6):1334-40. doi: 10.1249/MSS.0b013e3181984fa8.
Results Reference
result
PubMed Identifier
19637244
Citation
Mosher CE, Sloane R, Morey MC, Snyder DC, Cohen HJ, Miller PE, Demark-Wahnefried W. Associations between lifestyle factors and quality of life among older long-term breast, prostate, and colorectal cancer survivors. Cancer. 2009 Sep 1;115(17):4001-9. doi: 10.1002/cncr.24436.
Results Reference
result
PubMed Identifier
22879576
Citation
Ottenbacher A, Sloane R, Snyder DC, Kraus W, Sprod L, Demark-Wahnefried W. Cancer-specific concerns and physical activity among recently diagnosed breast and prostate cancer survivors. Integr Cancer Ther. 2013 May;12(3):206-12. doi: 10.1177/1534735412449734. Epub 2012 Aug 9.
Results Reference
result
PubMed Identifier
22544562
Citation
Mosher CE, Lipkus I, Sloane R, Snyder DC, Lobach DF, Demark-Wahnefried W. Long-term outcomes of the FRESH START trial: exploring the role of self-efficacy in cancer survivors' maintenance of dietary practices and physical activity. Psychooncology. 2013 Apr;22(4):876-85. doi: 10.1002/pon.3089. Epub 2012 Apr 30.
Results Reference
result
PubMed Identifier
22249915
Citation
Ottenbacher AJ, Day RS, Taylor WC, Sharma SV, Sloane R, Snyder DC, Lipkus IM, Jones LW, Demark-Wahnefried W. Long-term physical activity outcomes of home-based lifestyle interventions among breast and prostate cancer survivors. Support Care Cancer. 2012 Oct;20(10):2483-9. doi: 10.1007/s00520-011-1370-y. Epub 2012 Jan 17.
Results Reference
result
PubMed Identifier
21061408
Citation
Wilkinson AV, Barrera SL, McBride CM, Snyder DC, Sloane R, Meneses KM, Pekmezi D, Kraus WE, Demark-Wahnefried W. Extant health behaviors and uptake of standardized vs tailored health messages among cancer survivors enrolled in the FRESH START trial: a comparison of fighting-spirits vs fatalists. Psychooncology. 2012 Jan;21(1):108-13. doi: 10.1002/pon.1870. Epub 2010 Nov 8.
Results Reference
result
PubMed Identifier
19081749
Citation
Demark-Wahnefried W. Print-to-Practice: Designing Tailored Print Materials to Improve Cancer Survivors' Dietary and Exercise Practices in the FRESH START Trial. Nutr Today. 2007 May;42(3):131-138. doi: 10.1097/01.NT.0000277790.03666.95. No abstract available.
Results Reference
result
PubMed Identifier
17182834
Citation
Stull VB, Snyder DC, Demark-Wahnefried W. Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. J Nutr. 2007 Jan;137(1 Suppl):243S-248S. doi: 10.1093/jn/137.1.243S.
Results Reference
result
PubMed Identifier
25155573
Citation
Adams RN, Mosher CE, Blair CK, Snyder DC, Sloane R, Demark-Wahnefried W. Cancer survivors' uptake and adherence in diet and exercise intervention trials: an integrative data analysis. Cancer. 2015 Jan 1;121(1):77-83. doi: 10.1002/cncr.28978. Epub 2014 Aug 25.
Results Reference
result
PubMed Identifier
26512712
Citation
Morey MC, Blair CK, Sloane R, Cohen HJ, Snyder DC, Demark-Wahnefried W. Group trajectory analysis helps to identify older cancer survivors who benefit from distance-based lifestyle interventions. Cancer. 2015 Dec 15;121(24):4433-40. doi: 10.1002/cncr.29684. Epub 2015 Oct 29.
Results Reference
result

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Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer

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