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Completed

NCT Number: NCT00340015

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

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.

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Key information

Age range

50 year–71 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. Incident Cancer

    Time frame: 12/31/2030

    All cancers

  2. All cause and disease specific mortality

    Time frame: 12/31/2030

    All cause and disease specific mortality

  3. Chronic diseases

    Time frame: 12/31/2030

    Chronic diseases

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

NCI-AARP Diet and Health Study

Important dates

Study start
1995
Primary completion
2015
Study completion
2015
First posted
Jun 21, 2006
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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