Breast CancerHOWNCT02334085
The Health of Women Study
An observational study of Breast Cancer, run by Dr. Susan Love Research Foundation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 55,008 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to 18 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Men
- Women
- 18 years and older
Who cannot join
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Susan Love Research Foundation
Santa Monica, California, 90403
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HOW study participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of the cohort study, up to 20 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startAug 2009
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Susan Love Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Love, MD, Principal investigator, Dr. Susan Love Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334085
- Sponsor's protocol ID
- 20091527
- Acronym
- HOW
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2014
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Health of Women (HOW) Study
- ClinicalTrials.gov ID
- NCT02334085
- Acronym / sponsor ID
- HOW / 20091527
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55,008 participants (actual)
- Lead sponsor
- Dr. Susan Love Research FoundationUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOW study participants | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Men
- Women
- 18 years and older
Key exclusion criteria (1 listed)
- Under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Love, MD principal investigator
Dr. Susan Love Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Dr. Susan Love Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast cancer diagnosis question (time frame: Participants will be followed for the duration of the cohort study, up to 20 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.