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

• ClinicalTrials.gov Identifier: NCT03253666
• Recruitment Status: Completed
• First Posted: August 18, 2017
• Last Update Posted: July 15, 2020
• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: National Institutes of Health (NIH); Brown University
• Information provided by (Responsible Party): Ashar Dhana, Harvard School of Public Health (HSPH)

Tracking Information

• First Submitted Date: August 11, 2017
• First Posted Date: August 18, 2017
• Last Update Posted Date: July 15, 2020
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2017)

Multiple skin diseases [ Time Frame: Skin disease/cancer [ NHS: Time Frame: 1984 - 2010 ] [ HPFS: Time Frame: 1986 - 2010 ]. Person time contribution from date of return of questionnaire to date of first report of skin disease/death/end of follow-up (whichever came first) ]

Includes skin cancer, psoriasis, and other inflammatory and autoimmune skin diseases.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Nurses' Health Study and Health Professionals Follow-Up Study (Dermatological Component)
• Official Title: Nurses' Health Study and Health Professionals Follow-Up Study (Dermatological Component)
• Brief Summary: 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

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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 30 Years
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: See "Detailed Description"

Condition

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

Intervention

Other: Nutrient Intake

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

Study Groups/Cohorts

• Nurses' Health Study
  See "Detailed Description"
  Intervention: Other: Nutrient Intake
• Health Professionals Follow-Up Study
  See "Detailed Description"
  Intervention: Other: Nutrient Intake

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 15, 2017): 173229
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2018
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03253666
• Other Study ID Numbers: CA186107
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Ashar Dhana, Harvard School of Public Health (HSPH)
• Original Responsible Party: Same as current
• Current Study Sponsor: Harvard School of Public Health (HSPH)
• Original Study Sponsor: Same as current

Collaborators

• National Institutes of Health (NIH)
• Brown University

• Investigators: Not Provided
• PRS Account: Harvard School of Public Health (HSPH)
• Verification Date: July 2020