NCT02334085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55,008

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2019

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

10 years

First QC Date

December 18, 2014

Last Update Submit

December 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Other Outcomes (5)

  • Questions about general health status

    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

    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

    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.

  • +2 more other outcomes

Study Arms (1)

HOW study participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Men
  • Women
  • years and older

You may not qualify if:

  • Under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Susan Love Research Foundation

Santa Monica, California, 90403, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Susan Love, MD

    Dr. Susan Love Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2014

First Posted

January 8, 2015

Study Start

August 1, 2009

Primary Completion

July 18, 2019

Study Completion

July 18, 2019

Last Updated

December 13, 2019

Record last verified: 2019-12

Locations