Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care
ConditionBreast Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCity of Hope Medical Center
About this trial
This study evaluates patient and provider attitudes about environmental exposure risk assessments into clinical care for female patients at average or high risk for breast cancer and/or diagnosed with early onset breast cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no Pathogenic/Likely Pathogenic [P/LP] in breast cancer related genes) OR high risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model or gene mutation carrier, P/LP carrier in breast cancer related genes including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53) OR early onset breast cancer (defined by a breast cancer diagnosis in a patient younger than 50 years of age)
Age: ≥ 18 years
Speak English or Spanish
Sex: female
Disqualifiers
None
Trial population
Female patients aged 18 years or older who either are considered average risk for developing breast cancer or high-risk for developing breast cancer or have early-onset breast cancer as well as providers at City of Hope.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
423 Participants
are divided into 3 treatment groupsGroup A: Observational Aim I1 intervention
Group B: Observational Aim II1 intervention
Group C: Observational Aim III1 intervention
Trial outcomes
Primary outcomes
1
Patient survey responses on perceived utility
Will compare emotional responses, environmental health literacy, compensatory health behaviors, and cancer fatalism across the three participant groups (average risk, high risk, and early onset) using analysis of covariance (ANCOVA). Emotional response scores will be constructed by summing items within the positive and negative subscales separately, while the environmental health literacy, compensatory health behaviors and cancer fatalism will be calculated as summed total scores. ANCOVA will be used to estimate adjusted mean differences across groups and to evaluate whether post intervention responses differ after accounting for demographic factors. Interview sessions will be audio-recorded and transcribed verbatim.
Time frame
Up to one year2
Patient survey responses on willingness to engage
Will compare emotional responses, environmental health literacy, compensatory health behaviors, and cancer fatalism across the three participant groups (average risk, high risk, and early onset) using ANCOVA. Emotional response scores will be constructed by summing items within the positive and negative subscales separately, while the environmental health literacy, compensatory health behaviors and cancer fatalism will be calculated as summed total scores. ANCOVA will be used to estimate adjusted mean differences across groups and to evaluate whether post intervention responses differ after accounting for demographic factors. Interview sessions will be audio-recorded and transcribed verbatim.
Time frame
Up to one year3
Patient survey responses on preferences for receiving EERA results
Will compare emotional responses, environmental health literacy, compensatory health behaviors, and cancer fatalism across the three participant groups (average risk, high risk, and early onset) using ANCOVA. Emotional response scores will be constructed by summing items within the positive and negative subscales separately, while the environmental health literacy, compensatory health behaviors and cancer fatalism will be calculated as summed total scores. ANCOVA will be used to estimate adjusted mean differences across groups and to evaluate whether post intervention responses differ after accounting for demographic factors. Interview sessions will be audio-recorded and transcribed verbatim.
Time frame
Up to one year4
Provider survey responses on perceived utility
Descriptive analysis will be used to examine all quantitative variables.
Time frame
Up to one yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov