Breast Cancer Clinical Trial
— HOWOfficial title:
The Health of Women (HOW) Study
| NCT number | NCT02334085 |
| Other study ID # | 20091527 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2009 |
| Est. completion date | July 18, 2019 |
| Verified date | December 2019 |
| Source | Dr. Susan Love Research Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 55008 |
| Est. completion date | July 18, 2019 |
| Est. primary completion date | July 18, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Men - Women - 18 years and older Exclusion Criteria: - Under the age of 18 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Dr. Susan Love Research Foundation | Santa Monica | California |
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Susan Love Research Foundation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Questions about general health status | 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. | |
| Other | Questions about personal and family health history | 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. | |
| Other | Questions about health, weight, and exercise | 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. | |
| Other | Questions about environmental exposures | 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. | |
| Other | Questions about health symptoms (quality of life) | 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. | |
| Primary | Breast cancer diagnosis question | 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. |
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