Nurses' Health Study and Health Professionals Follow-Up Study (Dermatological Component)

NCT ID: NCT03253666

Last Updated: 2020-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-05-31

Brief Summary

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To determine the relationships of dietary factors with the subsequent risk of dermatological diseases (such as skin cancers and inflammatory or autoimmune dermatoses) in a cohort of female registered nurses and male health professionals.

Detailed Description

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The study population consisted of two ongoing cohorts: the Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS). The NHS began in 1976 when 121,700 female nurses aged 33-55 years and residing in the United States responded to a baseline questionnaire. The HPFS began in 1986 when 51,529 male health professionals aged 40-75 years and residing in the United States completed a similar baseline questionnaire. Study investigators sent follow-up questionnaires biennially to participants to update information on past medical history as well as lifestyle factors.

Follow up was started in 1984 for the NHS and 1986 for the HPFS when diet was measured with an expanded food frequency questionnaire (FFQ). Participants in the NHS responded to an \~130 item semi-quantitative FFQ in 1984, 1986, and then every four years thereafter, while those in the HPFS responded to a similar FFQ in 1986 and then every four years thereafter. The FFQ collected information on average intake of each food item over the past year. It also specified a common serving size for each item. Participants could select from one of nine intake frequency choices, ranging from less than once per month to six or more times per day. Participants also provided information on current use and dose of multivitamins and use of other vitamin supplements.

For both cohorts, investigators repeatedly collected and updated information on several anthropometric and lifestyle factors such as weight, smoking status, alcohol use, coffee intake, and physical activity level. Information was also collected on several major risk factors for skin disease such as family history of melanoma, number of arm moles, natural hair color, sunburn susceptibility as a child or adolescent, number of lifetime blistering sunburns, type of tan after repeated sun exposure as a child or adolescent, and cumulative ultraviolet flux since baseline.

Study subjects reported new diagnoses biennially. After obtaining permission from participants, their medical and pathological records were acquired. Study physicians blinded to questionnaire information reviewed these records to confirm diagnoses

The study was approved by the institutional review boards of both Brigham and Women's Hospital and Harvard T.H Chan School of Public Health.

Conditions

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Skin Cancer Melanoma Non-melanoma Skin Cancer Psoriasis Rosacea Lupus Erythematosus Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nurses' Health Study

See "Detailed Description"

Nutrient Intake

Intervention Type OTHER

Dietary nutrient intake (such as folate) and supplemental nutrient intake (such as folic acid)

Health Professionals Follow-Up Study

See "Detailed Description"

Nutrient Intake

Intervention Type OTHER

Dietary nutrient intake (such as folate) and supplemental nutrient intake (such as folic acid)

Interventions

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Nutrient Intake

Dietary nutrient intake (such as folate) and supplemental nutrient intake (such as folic acid)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

-Participants of these two cohorts

Exclusion Criteria

* Participants with missing data on dietary intake at baseline
* Participants with a prior history of cancer (except non-melanoma skin cancer)
* For skin cancer, non-white participants because of low risk of skin cancer (such as melanoma) and small numbers.
* For melanoma, participants with in-situ melanomas, which comprise tumours restricted to the epidermis of the skin.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Ashar Dhana

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Li WQ, Cho E, Weinstock MA, Mashfiq H, Qureshi AA. Epidemiological Assessments of Skin Outcomes in the Nurses' Health Studies. Am J Public Health. 2016 Sep;106(9):1677-83. doi: 10.2105/AJPH.2016.303315. Epub 2016 Jul 26.

Reference Type RESULT
PMID: 27459457 (View on PubMed)

Related Links

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Other Identifiers

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CA186107

Identifier Type: -

Identifier Source: org_study_id

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