Clinical trial NCT00340015: A Prospective Study of Diet and Cancer in Members of the American Association of Retired Persons
Official title: NCI-AARP Diet and Health Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Cancer
Keywords: Cancer
Mortality
Lifestyle Factors
Nutrition
Prospective Cohort
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 566401
Sex: ALL
Minimum age (years): 50
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of the AARP (formally the American Association of Retired Persons), aged 50-71 years, and who resided in one of six states (California, Florida, Pennsylvania, New Jersey, North Carolina, and Louisiana) or in two metropolitan areas (Atlanta, Georgia and Detroit, Michigan) in 1995-1996.

Brief summary: This is a prospective cohort study of diet and cancer in relation to several major cancers, especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-6 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument.

In terms of field activities, the study has been relatively quiescent over the past year. At the end of the five-year period of observation, we will mail to cohort members a brief follow-up questionnaire primarily targeted to endpoint assessment. (Because of cancer registry lag-time, we do not expect to mail this questionnaire until early 2002.) Follow-up will be largely passive, through established state registries. The initial questionnaire mailing will be to AARP members in those states selected on the basis of having registries with adequate coverage and quality. We will use active follow-up, with record retrieval, for the small percentage of cohort members who have moved out of the cancer registry areas. The buccal cell collection pilot study has been completed; over 50% of those pilot study partricipants who had completed the baseline and risk factor questionnaires returned buccal cell speciments. Preliminary data from a pilot study of the end point ascertainment procedure indicate that cohort incidence rates for major cancers, determined from registry data, are consistent with SEER rates.

Detailed description: This is a prospective cohort study to investigate relations among diet, lifestyle and cancer. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-96 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument. In 2004-2006 we mailed a follow-up questionnaire to all living participants to assess non-cancer endpoints and lifestyle factors.

Eligibility criteria: * INCLUSION CRITERIA:

Patients participating will be selected from the American Association of Retired Persons age 50-69 living in one of the following state and metropolitan areas: California (minus Los Angeles county), Florida, Pennsylvania, New Jersey, Louisiana, North Carolina, Detroit, and Atlanta.

Primary outcomes:
measure: Incident Cancer
timeFrame: 12/31/2030
measure: All cause and disease specific mortality
timeFrame: 12/31/2030
measure: Chronic diseases
timeFrame: 12/31/2030
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI), 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Rashmi Sinha, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Keadle SK, Moore SC, Sampson JN, Xiao Q, Albanes D, Matthews CE. Causes of Death Associated With Prolonged TV Viewing: NIH-AARP Diet and Health Study. Am J Prev Med. 2015 Dec;49(6):811-21. doi: 10.1016/j.amepre.2015.05.023. Epub 2015 Jul 26.
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citation: Jiao L, Stolzenberg-Solomon R, Zimmerman TP, Duan Z, Chen L, Kahle L, Risch A, Subar AF, Cross AJ, Hollenbeck A, Vlassara H, Striker G, Sinha R. Dietary consumption of advanced glycation end products and pancreatic cancer in the prospective NIH-AARP Diet and Health Study. Am J Clin Nutr. 2015 Jan;101(1):126-34. doi: 10.3945/ajcn.114.098061. Epub 2014 Nov 19.
citation: Tasevska N, Park Y, Jiao L, Hollenbeck A, Subar AF, Potischman N. Sugars and risk of mortality in the NIH-AARP Diet and Health Study. Am J Clin Nutr. 2014 May;99(5):1077-88. doi: 10.3945/ajcn.113.069369. Epub 2014 Feb 19.
citation: Li WQ, Park Y, Wu JW, Goldstein AM, Taylor PR, Hollenbeck AR, Freedman ND, Abnet CC. Index-based dietary patterns and risk of head and neck cancer in a large prospective study. Am J Clin Nutr. 2014 Mar;99(3):559-66. doi: 10.3945/ajcn.113.073163. Epub 2014 Jan 8.
citation: Daniel CR, Park Y, Chow WH, Graubard BI, Hollenbeck AR, Sinha R. Intake of fiber and fiber-rich plant foods is associated with a lower risk of renal cell carcinoma in a large US cohort. Am J Clin Nutr. 2013 May;97(5):1036-43. doi: 10.3945/ajcn.112.045351. Epub 2013 Mar 20.
citation: Sinha R, Cross AJ, Daniel CR, Graubard BI, Wu JW, Hollenbeck AR, Gunter MJ, Park Y, Freedman ND. Caffeinated and decaffeinated coffee and tea intakes and risk of colorectal cancer in a large prospective study. Am J Clin Nutr. 2012 Aug;96(2):374-81. doi: 10.3945/ajcn.111.031328. Epub 2012 Jun 13.
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citation: Daniel CR, Cross AJ, Graubard BI, Park Y, Ward MH, Rothman N, Hollenbeck AR, Chow WH, Sinha R. Large prospective investigation of meat intake, related mutagens, and risk of renal cell carcinoma. Am J Clin Nutr. 2012 Jan;95(1):155-62. doi: 10.3945/ajcn.111.019364. Epub 2011 Dec 14.