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The Health of Women Study (HOW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02334085
Recruitment Status : Completed
First Posted : January 8, 2015
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Susan Love Research Foundation

Brief Summary:
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.

Condition or disease
Breast Cancer

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Study Type : Observational
Actual Enrollment : 55008 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Health of Women (HOW) Study
Study Start Date : August 2009
Actual Primary Completion Date : July 18, 2019
Actual Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
HOW study participants



Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • Men
  • Women
  • 18 years and older

Exclusion Criteria:

  • Under the age of 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334085


Locations
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United States, California
Dr. Susan Love Research Foundation
Santa Monica, California, United States, 90403
Sponsors and Collaborators
Dr. Susan Love Research Foundation
Investigators
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Principal Investigator: Susan Love, MD Dr. Susan Love Research Foundation
Additional Information:
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Responsible Party: Dr. Susan Love Research Foundation
ClinicalTrials.gov Identifier: NCT02334085    
Other Study ID Numbers: 20091527
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019