A Prospective Study of Diet and Cancer in Members of the American Association of Retired Persons

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00340015

Collaborator

(none)

566,401

Enrollment

Location

232.1

Actual Duration (Months)

2440.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Death Cancer

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.

Study Design

Study Type:

Observational

Actual Enrollment :

566401 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

NCI-AARP Diet and Health Study

Actual Study Start Date :

Oct 24, 1995

Actual Primary Completion Date :

Feb 25, 2015

Actual Study Completion Date :

Feb 25, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Incident Cancer [12/31/2030]
All cancers
All cause and disease specific mortality [12/31/2030]
All cause and disease specific mortality
Chronic diseases [12/31/2030]
Chronic diseases

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 71 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.