Family-Based Intervention Study of the Effects of Environmental Exposures on Breast Tissue Composition

Columbia University

Status: Completed

Conditions: Breast Cancer Risk

Treatments: Behavioral: Breast Cancer Risk Reduction Household Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04265547

5U01ES026127-04 (U.S. NIH Grant/Contract)

AAAS2359

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Female

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Mother-daughter pairs will partake in an educational session at the baseline visit, which will cover topics on reading product labels, cleaning habit, and cooking methods for reducing environmental exposures. Educational materials will be adapted from the Environmental Protection Agency (EPA) and other accredited sources. Participants will also be introduced to free resources for consumer product safety information, such as the Detox Me phone application. Participants in the intervention arm will receive a 6-month supply of soap, lotion, deodorant, lip balm, a mop, cleaning cloths, and an air filter to take home with them. Mother-daughter pairs in both study arms will return for a second clinic visit 6 months after the pre-intervention visit for blood and urine sample collection, Optical Spectroscopy (OS) measurement, and questionnaire completion.

Treatment:

Behavioral: Breast Cancer Risk Reduction Household Intervention

Control Arm

No Intervention group

Description:

Mother-daughter pairs will partake in an educational session at the baseline visit, which will cover topics on reading product labels, cleaning habit, and cooking methods for reducing environmental exposures. Educational materials will be adapted from the Environmental Protection Agency (EPA) and other accredited sources. Participants will also be introduced to free resources for consumer product safety information, such as the Detox Me phone application. Mother-daughter pairs in both study arms will return for a second clinic visit 6 months after the pre-intervention visit for blood and urine sample collection, Optical Spectroscopy (OS) measurement, and questionnaire completion. Control arm participants will be offered the chemical-free products, cleaning supplies, and air filter at this time.