NCT00340015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
566,401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 1995

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2015

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

19.4 years

First QC Date

June 19, 2006

Last Update Submit

January 4, 2022

Conditions

Keywords

CancerMortalityLifestyle FactorsNutritionProspective CohortNatural History

Outcome Measures

Primary Outcomes (3)

  • Incident Cancer

    All cancers

    12/31/2030

  • All cause and disease specific mortality

    All cause and disease specific mortality

    12/31/2030

  • Chronic diseases

    Chronic diseases

    12/31/2030

Study Arms (1)

AARP

Members of the AARP, aged 50-71 years, and who resided in one of six states

Eligibility Criteria

Age50 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (17)

  • Zhuang P, Wu F, Mao L, Zhu F, Zhang Y, Chen X, Jiao J, Zhang Y. Egg and cholesterol consumption and mortality from cardiovascular and different causes in the United States: A population-based cohort study. PLoS Med. 2021 Feb 9;18(2):e1003508. doi: 10.1371/journal.pmed.1003508. eCollection 2021 Feb.

  • Willis EA, Huang WY, Saint-Maurice PF, Leitzmann MF, Salerno EA, Matthews CE, Berndt SI. Increased frequency of intentional weight loss associated with reduced mortality: a prospective cohort analysis. BMC Med. 2020 Sep 17;18(1):248. doi: 10.1186/s12916-020-01716-5.

  • Zhuang P, Zhang Y, He W, Chen X, Chen J, He L, Mao L, Wu F, Jiao J. Dietary Fats in Relation to Total and Cause-Specific Mortality in a Prospective Cohort of 521 120 Individuals With 16 Years of Follow-Up. Circ Res. 2019 Mar;124(5):757-768. doi: 10.1161/CIRCRESAHA.118.314038.

  • Hashemian M, Murphy G, Etemadi A, Dawsey SM, Liao LM, Abnet CC. Nut and peanut butter consumption and the risk of esophageal and gastric cancer subtypes. Am J Clin Nutr. 2017 Sep;106(3):858-864. doi: 10.3945/ajcn.117.159467. Epub 2017 Aug 2.

  • Keadle SK, Arem H, Moore SC, Sampson JN, Matthews CE. Impact of changes in television viewing time and physical activity on longevity: a prospective cohort study. Int J Behav Nutr Phys Act. 2015 Dec 18;12:156. doi: 10.1186/s12966-015-0315-0.

  • Xu M, Huang T, Lee AW, Qi L, Cho S. Ready-to-Eat Cereal Consumption with Total and Cause-Specific Mortality: Prospective Analysis of 367,442 Individuals. J Am Coll Nutr. 2016;35(3):217-23. doi: 10.1080/07315724.2014.971193. Epub 2015 Nov 23.

  • 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.

  • Kabat GC, Matthews CE, Kamensky V, Hollenbeck AR, Rohan TE. Adherence to cancer prevention guidelines and cancer incidence, cancer mortality, and total mortality: a prospective cohort study. Am J Clin Nutr. 2015 Mar;101(3):558-69. doi: 10.3945/ajcn.114.094854. Epub 2015 Jan 7.

  • Matthews CE, Moore SC, Sampson J, Blair A, Xiao Q, Keadle SK, Hollenbeck A, Park Y. Mortality Benefits for Replacing Sitting Time with Different Physical Activities. Med Sci Sports Exerc. 2015 Sep;47(9):1833-40. doi: 10.1249/MSS.0000000000000621.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Daniel CR, Sinha R, Park Y, Graubard BI, Hollenbeck AR, Morton LM, Cross AJ. Meat intake is not associated with risk of non-Hodgkin lymphoma in a large prospective cohort of U.S. men and women. J Nutr. 2012 Jun;142(6):1074-80. doi: 10.3945/jn.112.158113. Epub 2012 Apr 25.

  • Matthews CE, George SM, Moore SC, Bowles HR, Blair A, Park Y, Troiano RP, Hollenbeck A, Schatzkin A. Amount of time spent in sedentary behaviors and cause-specific mortality in US adults. Am J Clin Nutr. 2012 Feb;95(2):437-45. doi: 10.3945/ajcn.111.019620. Epub 2012 Jan 4.

  • 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.

MeSH Terms

Conditions

DeathNeoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rashmi Sinha, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

October 24, 1995

Primary Completion

February 25, 2015

Study Completion

February 25, 2015

Last Updated

January 5, 2022

Record last verified: 2022-01

Locations