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Study Summary
No. 2008-0552:.......Breast......Lovell A. Jones......Health Disparities Research
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Study Summary Title
Study Summary
Number:
2008-0552
Study Title:WHEL (Women's Healthy Eating and Living) Survivorship Study
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Physician New Patient Referral
Name:Lovell A. JonesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Health Disparities ResearchReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3275
Contact us about clinical trials
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General Information
Disease Group:BreastSupported By:National Cancer Institute
Phase of Study:N/AReturn
Visit:
Participants will not have to come to MD Anderson. Study will be conducted via
mail correspondance and telephone.
Treatment
Agents:
NoneHome Care:This is not a treatment protocol.
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
Not applicable.
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
This is a continuation of GYN96-052, The Women's Healthy Eating and Living (WHEL) Study, which determined in a randomized-controlled trial whether a low-fat high-fiber diet that is high in nutrient- and phytochemical-rich vegetables and fruits is associated with a longer breast cancer event-free interval and increased longevity in women previously treated for early stage breast cancer (Pierce et al. 2007). The dietary intervention produced substantial differences in consumption of vegetables, fruits, fiber, and fat between the intervention group and the comparison group (who were given USDA and NCI dietary guidelines). While there was no overall effect, there was a significant effect in a large subgroup defined by vasomotor symptoms.

Primary Aim
To re-enroll the WHEL breast cancer cohort and to continue to undertake health and vitality assessments of all participants events to allow further investigation of sub-groups (using biological samples) to identify predictors of longevity in this study population.

Secondary Aims

• To test the effect of the published study finding on the diets of the participants in the WHEL Study.

• To conduct secondary analyses on the effect of surgery (e.g., oophorectomy) and lifestyle factors on cancer events that will be collected through 2012. Investigate predictors of late cancer events (i.e. events occurring > 7 years post-diagnosis).

The WHEL Study has collected and will continue to collect through 2012 detailed data, which includes measures of dietary pattern, physical activity, central obesity, body mass index, depression and quality of life, other cancer screening practices, medication use, use of nutrient supplements, use of screening services for other cancers, etc. The WHEL Study team has a good track record of exploring and disseminating important findings. The investigator team will continue to analyze the wealth of data collected on the WHEL Study, publishing the results in high quality journals.
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Study Status Information
Study Activation / Registration Date:09/11/2008
IRB Review and Approval Date:09/11/2008
Study Type:Other
Recruitment Status:Open
Projected Accrual:2445
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Previously enrolled in the WHEL Study (Protocol: GYN96-052).

2) Indicated willingness to participate in a follow-up study on the exit interview for GYN96-052.

Exclusion Criteria:1) Indicated unwillingness to participate in a follow-up study on the exit interview for GYN96-052.

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Links
Registration Number: NCT00003787
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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