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

    • California
      • Santa Monica, California, United States, 90403
        • Dr. Susan Love Research Foundation

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
HOW study participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast cancer diagnosis question
Time Frame: Participants will be followed for the duration of the cohort study, up to 20 years.
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.
Participants will be followed for the duration of the cohort study, up to 20 years.

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.
Demographic characteristics will be obtained, questions about menstruation, pregnancy, hormone use, and lifestyle behaviors are asked in the "My Health Overview" questionnaire.
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.
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.
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.
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.
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.
The "Health, Weight, and Exercise" questionnaire asks about sleeping patterns, weight status, a variety of exercise questions, daily activities, and prescription use.
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.
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.
The "Environmental Exposures" questionnaire asks about cosmetic product usage, personal hygiene product usage, and second hand smoke exposure.
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.
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.
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.
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.

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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