Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-04271 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 260159 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
PRIMARY OBJECTIVES:
I. To assess patient interest and emotional responses toward EERA and return of results.
II. To assess provider attitudes toward EERA integration into clinical workflows.
OUTLINE: This is an observational study. Participants are assigned to 1 of 3 aims.
AIM I: Average and high risk breast cancer participants and early onset breast cancer patients complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' and patients' medical records are reviewed.
AIM II: COH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes.
AIM III: Average and high risk breast cancer participants complete a baseline survey over 15-25 minutes and wear Fresh Air Clip wristbands for 1 week. Participants then complete a follow up survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' medical records are reviewed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Aim I | Average and high risk breast cancer participants and early onset breast cancer patients complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' and patients' medical records are reviewed. |
| |
| Observational Aim II | COH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes. |
| |
| Observational Aim III | Average and high risk breast cancer participants complete a baseline survey over 15-25 minutes and wear Fresh Air Clip wristbands for 1 week. Participants then complete a follow up survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' medical records are reviewed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to one year |
| 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. | Up to one year |
| 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. |
Not provided
Not provided
Inclusion Criteria:
AIM 1 INCLUSION CRITERIA:
ONE of the following:
Age: ≥ 18 years
Speak English or Spanish
Sex: female
Willingness to:
AIM 2 INCLUSION CRITERIA
Practice at COH (i.e., genetic counselors, geneticists, oncologists, nurse practitioners)
Willingness to:
AIM 3 INCLUSION CRITERIA:
Provide written consent
ONE of the following:
Age: ≥ 18 years
Speak English or Spanish
Sex: female
Willingness to:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stacy W Gray | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to one year |
| Provider survey responses on perceived utility | Descriptive analysis will be used to examine all quantitative variables. | Up to one year |
| Provider survey responses on feasibility | Descriptive analysis will be used to examine all quantitative variables. | Up to one year |
| Provider survey responses on preferences for EERA disclosures into workflows | Descriptive analysis will be used to examine all quantitative variables. | Up to one year |
| Proportion of participants who wear the work wristband for a total of 1 week | Feasibility will be defined as the proportion of participants who wear the work wristband for a total of 1 week. The feasibility rate will be summarized descriptively using point estimates and 95% confidence intervals. | Up to one year |
| Chemical exposure measured by Fresh Air Clip wristband | Acceptability will be measured in the follow-up survey using the question: "Overall, how acceptable did you find wearing the 'Fresh Air clip' wristband to measure chemical exposures in your daily life?" Participants who respond "No opinion," "Acceptable," or "Completely acceptable" will be categorized as finding the wristband acceptable. The acceptability rate will be summarized descriptively using point estimates and 95% confidence intervals. | Up to one year |
| D017437 |
| Skin and Connective Tissue Diseases |