Family-Based Intervention Study of the Effects of Environmental Exposures on Breast Tissue Compos… (NCT04265547) | Clinical Trial Compass
CompletedNot Applicable
Family-Based Intervention Study of the Effects of Environmental Exposures on Breast Tissue Composition
United States32 participantsStarted 2020-01-25
Plain-language summary
This research study is being conducted to find out whether changes in household and personal behavior aimed at reducing exposure to environmental chemicals in dust (increased house dust removal efforts/cleaning and hand washing) and consumer products (increased us of personal care and beauty products that are free of chemicals including phthalates, parabens, and phenols) results in lower exposure to environmental chemicals including polycyclic aromatic hydrocarbons (PAHs) and endocrine disrupting chemicals including phthalates, parabens and phenols. These chemicals may have harmful health effects, as they can interfere with normal functions of the body. This study will also assess changes in breast tissue composition to understand the role of environmental exposures in breast cancer risk.
Who can participate
Age range
10 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant of Columbia's Breast Cancer Research and the Environment (BCERP) Study that recruited from the Columbia Children's Center for Environmental Health (CCCEH) Mothers and Newborns cohort.
* Mother did not smoke or use illicit drugs prior to or during pregnancy (referring to pregnancy for participating daughter).
* Mother was 18-35 years at time of daughter's delivery.
* Mother registered in the prenatal clinics by the 20th week of pregnancy.
* Mother free of diabetes, hypertension and reported HIV infection.
* Mother resided in northern Manhattan or the South Bronx neighborhoods of New York City for at least one year prior to pregnancy.
* Mother self-identified as African-American or Dominican.
* Only participants in the CCCEH birth cohort who answered in the affirmative to the question "I would like to be contacted about future studies" on the consent form of the Mothers and Newborns Study will be contacted to participate in this intervention.
Exclusion Criteria:
• None
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of lipid (mg/cm^3) measured using an Optical Spectroscopy machine.
Timeframe: Baseline, 6 months
2
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of water (mg/cm^3) measured using an Optical Spectroscopy machine.
Timeframe: Baseline, 6 months
3
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of collagen (mg/cm^3) measured using an Optical Spectroscopy machine.
Timeframe: Baseline, 6 months
4
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of total hemoglobin (μM) measured using an Optical Spectroscopy machine.
Timeframe: Baseline, 6 months
5
Feasibility of measuring pre/post-intervention change in participants' breast tissue concentration of oxygenated hemoglobin (%) measured using an Optical Spectroscopy machine.
Timeframe: Baseline, 6 months
6
Feasibility of measuring pre/post-intervention change in urinary metabolites of endocrine disrupting chemicals, including polycyclic aromatic hydrocarbons (PAH), phthalates, and parabens (all measured in μg/L units) .