NCT00901966

Brief Summary

This K07 Career Development Award application is designed to expand Dr. Dennis career development from cancer etiology to cancer prevention and control. The career development plan rests on mentoring directed by experts in cancer prevention research and protected time to foster my professional development as an independent cancer control researcher. A unique population, the Agricultural Health Study (AHS) cohort, will be used to examine sun exposure, sun protection behavior, and factors affecting these behaviors regarding the risk of melanoma in private pesticide applicators (farmers) and their spouses. The research plan proposed to examine skin melanoma within this prospective cohort of private applicators (mostly farmers) and their spouses in Iowa and North Carolina (the AHS) in association with environmental factors. Specific aim 1 examined the risk of melanoma in the AHS cohort using various existing measures of sun exposure adjusted for skin sensitivity and sun protection. Subsequently (for aim 2) qualitative research methods were used to design appropriate measures of sun exposure, sun protection behavior, and factors affecting these behaviors in private applicators and their spouses within the AHS based on the cohort analyses. Now Aim 3 will be completed by conducting a nested case-control study of melanoma within the AHS cohort to examine in more detail sun exposure histories and protective behavior. The questionnaire was designed based on findings from the cohort analyses (aim 1) and qualitative methods (aim 2). The risk of melanoma will be examined regarding: a) the complex relationship of cumulative (sun exposure during each decade of life) and intermittent sun exposure (sunburns and sunny vacations), b) factors affecting behavior including attitudes about sun exposure and prevention, and c) the use of tanning salons and sunless tanning creams, particularly in spouses (expected to be rare overall). The final aim is to use the results from the cohort and nested case-control studies to design a behavioral intervention, along with short computer automated telephone interview (CATI) that can be used in the whole AHS cohort or other farming populations. Funding for such studies will be sought through the R01) mechanism as an independent cancer control researcher. The behavioral intervention will be based on those factors that are the strongest risk factors for melanoma, highly prevalent, and easily modifiable. The behavioral intervention will be designed based on knowledge and skill gained from the Career Development Plan goals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
447

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Typical duration 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

May 12, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2013

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

May 13, 2009

Last Update Submit

October 27, 2020

Conditions

Keywords

MelanomaSun Exposure HistoryAgricultural Health StudySun Exposure

Outcome Measures

Primary Outcomes (1)

  • Prevalence of melanoma

    Diagnosis of melanoma after enrollment into Agricultural Health Study

    After enrollment

Study Arms (1)

Agricultural workers and spouses

Melanoma risk factors among Ag workers and spouses who use pesticides.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Members of the the AHS cohort -- registered private pesticide applicators (mostly farmers) and their spouses -- in Iowa.@@@@@@

You may qualify if:

  • Registered Agricultural Health Study (AHS) participants in Iowa

You may not qualify if:

  • prior cancer diagnosis other than melanoma
  • surrogates will not be used if a case has died before they are interviewed
  • participants under 18 will not be included.

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

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Laura Beane-Freeman

    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

May 13, 2009

First Posted

May 14, 2009

Study Start

May 12, 2009

Primary Completion

October 31, 2010

Study Completion

February 13, 2013

Last Updated

October 28, 2020

Record last verified: 2020-10

Locations