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MalnutritionNCT00044980

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

A study testing nutritional support and quality-of-life assessment in people with Malnutrition and Prostate Cancer, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Malnutrition, Prostate Cancer
What is being tested?
nutritional support and quality-of-life assessment
Type of treatment
Surgery or procedure
How many people
Not given
Where
1 siteUnited States
Study dates
Jul 2002to Dec 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Fresh Start: Promoting Health in Prostate Cancer Survivors

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.

Read the 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.

Being tested
nutritional support, quality-of-life assessment
Keywords
malnutrition, stage I prostate cancer, stage II B prostate cancer, stage II A prostate cancer
Medical subject headings
Malnutrition, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nutritional supportProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 2002
  3. Primary completionSep 2005
  4. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00044980
Sponsor's protocol ID
Pro00008521
Other IDs
DUMC-1306-04-7R3ER, DUMC-1306-01-7R2ER, NCI-H02-0090, CDR0000069500
Status last verified
Nov 2012
First submitted
6 Sep 2002
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12618570

  • 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.

    PubMed 16292046

  • 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.

    PubMed 22117660

  • 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.

    PubMed 21598023

  • 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.

  • 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.

    PubMed 17602076

  • 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.

    PubMed 15389420

  • 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.

    PubMed 18987083

  • 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.

    PubMed 18300337

  • 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.

    PubMed 18483353

  • 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.

    PubMed 19461530

  • 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.

    PubMed 19637244

  • 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.

    PubMed 22879576

  • 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.

    PubMed 22544562

  • 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.

    PubMed 22249915

Questions about this trial

What is this clinical trial studying?

A study testing nutritional support and quality-of-life assessment in people with Malnutrition and Prostate Cancer, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00044980, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.

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Clinical Trial NCT00044980 | AzTrials