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The Health of Women Study (HOW)

This study is currently recruiting participants.
Verified January 2015 by Dr. Susan Love Research Foundation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02334085
First Posted: January 8, 2015
Last Update Posted: January 8, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Susan Love Research Foundation
  Purpose
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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Health of Women (HOW) Study

Resource links provided by NLM:


Further study details as provided by Dr. Susan Love Research Foundation:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 100000
Study Start Date: August 2009
Estimated Study Completion Date: August 2031
Estimated Primary Completion Date: August 2029 (Final data collection date for primary outcome measure)
Groups/Cohorts
HOW study participants

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Allison Ottenbacher, PhD 310-828-0060 ext 29 aottenbacher@drsusanloveresearch.org

Locations
United States, California
Dr. Susan Love Research Foundation Recruiting
Santa Monica, California, United States, 90403
Contact: Allison Ottenbacher, PhD    310-828-0060 ext 29    aottenbacher@drsusanloveresearch.org   
Contact: Amaka Obidegwu, MPH    310-828-0060 ext 30    AObidegwu@drsusanloveresearch.org   
Principal Investigator: Susan Love, MD         
Sponsors and Collaborators
Dr. Susan Love Research Foundation
Investigators
Principal Investigator: Susan Love, MD Dr. Susan Love Research Foundation
  More Information

Additional Information:
Responsible Party: Dr. Susan Love Research Foundation
ClinicalTrials.gov Identifier: NCT02334085     History of Changes
Other Study ID Numbers: 20091527
First Submitted: December 18, 2014
First Posted: January 8, 2015
Last Update Posted: January 8, 2015
Last Verified: January 2015