- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02334085
The Health of Women Study (HOW)
December 12, 2019 updated by: Dr. Susan Love Research Foundation
The Health of Women (HOW) Study
The HOW Study is a first-of-its-kind international online study for women and men with and without a history of breast cancer.
The investigators will collect information about your health, your job, your diet, and your family history, among other topics that can help us get a better understanding of breast cancer and its potential causes.
Periodically, the investigators will send you questionnaires about anything and everything.
All you have to do is fill them out online.
It's that simple.
This is a partnership and the investigators need you for the long haul.
The more questionnaires you fill out, the more information the investigators will have that can help us have a better understanding of why women get breast cancer.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
55008
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Monica, California, United States, 90403
- Dr. Susan Love Research Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Women and men aged 18 and older, with or without breast cancer, and of all nationalities and ethnicities, from the United States and beyond, are encouraged to participate in the study.
Description
Inclusion Criteria:
- Men
- Women
- 18 years and older
Exclusion Criteria:
- Under the age of 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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HOW study participants
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Breast cancer diagnosis question
Time Frame: Participants will be followed for the duration of the cohort study, up to 20 years.
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In the "My Health Overview" questionnaire, the participant will be asked "have you been diagnosed with breast cancer?"
Responses available are yes, no, I don't know / I can't remember, and I'd rather not say.
This question will be asked in the initial questionnaire and every five years following that.
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Participants will be followed for the duration of the cohort study, up to 20 years.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questions about general health status
Time Frame: General health status questions are available at baseline, just after enrolling in the HOW study. Participants will be followed for the duration of the cohort study, up to 20 years.
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Demographic characteristics will be obtained, questions about menstruation, pregnancy, hormone use, and lifestyle behaviors are asked in the "My Health Overview" questionnaire.
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General health status questions are available at baseline, just after enrolling in the HOW study. Participants will be followed for the duration of the cohort study, up to 20 years.
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Questions about personal and family health history
Time Frame: Health history questions are available after the completion of the general health status questions. Participants will be followed for the duration of the cohort study, up to 20 years.
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The "My Personal and Family Health History" questionnaire asks about chronic conditions such as cancer, diabetes, hepatitis, and asthma, for the individual as well as their family members.
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Health history questions are available after the completion of the general health status questions. Participants will be followed for the duration of the cohort study, up to 20 years.
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Questions about health, weight, and exercise
Time Frame: Health, weight, and exercise questions are available after the completion of the health history questions. Participants will be followed for the duration of the cohort study, up to 20 years.
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The "Health, Weight, and Exercise" questionnaire asks about sleeping patterns, weight status, a variety of exercise questions, daily activities, and prescription use.
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Health, weight, and exercise questions are available after the completion of the health history questions. Participants will be followed for the duration of the cohort study, up to 20 years.
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Questions about environmental exposures
Time Frame: Environmental exposure questions are available after the completion of the health, weight, and exercise questions. Participants will be followed for the duration of the cohort study, up to 20 years.
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The "Environmental Exposures" questionnaire asks about cosmetic product usage, personal hygiene product usage, and second hand smoke exposure.
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Environmental exposure questions are available after the completion of the health, weight, and exercise questions. Participants will be followed for the duration of the cohort study, up to 20 years.
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Questions about health symptoms (quality of life)
Time Frame: Health symptom questions are available at baseline, just after enrolling in the HOW study. Participants will be followed for the duration of the cohort study, up to 20 years.
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The "Quality of Life" questionnaire asks about a variety of health symptoms including problems with digestion, concentration, sex, and mental health.
If you are a breast cancer survivor, you will be asked if these symptoms are related to your treatment.
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Health symptom questions are available at baseline, just after enrolling in the HOW study. Participants will be followed for the duration of the cohort study, up to 20 years.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan Love, MD, Dr. Susan Love Research Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
July 18, 2019
Study Completion (Actual)
July 18, 2019
Study Registration Dates
First Submitted
December 18, 2014
First Submitted That Met QC Criteria
January 6, 2015
First Posted (Estimate)
January 8, 2015
Study Record Updates
Last Update Posted (Actual)
December 13, 2019
Last Update Submitted That Met QC Criteria
December 12, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 20091527
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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