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Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care

27 augusti 2026 uppdaterad av: City of Hope Medical Center

Precision Prevention: Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

423

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Duarte, California, Förenta staterna, 91010
        • Rekrytering
        • City of Hope Medical Center
        • Huvudutredare:
          • Stacy W. Gray
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

  • AIM 1 INCLUSION CRITERIA:

    • ONE of the following:

      • 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

    • Willingness to:

      • Participate in study activities
      • Permit medical record/ clinical laboratory result review

  • AIM 2 INCLUSION CRITERIA

    • Practice at COH (i.e., genetic counselors, geneticists, oncologists, nurse practitioners)

    • Willingness to:

      • Participate in study activities

  • AIM 3 INCLUSION CRITERIA:

    • Provide written consent

    • ONE of the following:

      • Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no P/LP in breast cancer related genes) OR High risk: empirical risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model and no P/LP in breast cancer related genes) OR High Risk: gene carrier (defined by P/LP carrier in breast cancer related genes, including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53)
    • Age: ≥ 18 years
    • Speak English or Spanish
    • Sex: female

    • Willingness to:

      • Wear the wristband for 1 week
      • Participate in study activities
      • Permit medical record/ clinical laboratory result review

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Övrig: Icke-interventionsstudie
Icke-interventionsstudie
Andra namn:
  • Icke-interventionell observationsstudie
  • Icke -interventionell (observations) studie
Observational Aim II
COH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes.
Övrig: Icke-interventionsstudie
Icke-interventionsstudie
Andra namn:
  • Icke-interventionell observationsstudie
  • Icke -interventionell (observations) studie
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.
Övrig: Icke-interventionsstudie
Icke-interventionsstudie
Andra namn:
  • Icke-interventionell observationsstudie
  • Icke -interventionell (observations) studie

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient survey responses on perceived utility
Tidsram: Up to one year
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
Tidsram: Up to one year
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
Tidsram: Up to one year
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
Provider survey responses on perceived utility
Tidsram: Up to one year
Descriptive analysis will be used to examine all quantitative variables.
Up to one year
Provider survey responses on feasibility
Tidsram: Up to one year
Descriptive analysis will be used to examine all quantitative variables.
Up to one year
Provider survey responses on preferences for EERA disclosures into workflows
Tidsram: Up to one year
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
Tidsram: Up to one year
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
Tidsram: Up to one year
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

City of Hope Medical Center

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Stacy W Gray, City of Hope Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

28 december 2026

Primärt slutförande (Beräknad)

1 januari 2028

Avslutad studie (Beräknad)

1 januari 2028

Studieregistreringsdatum

Först inskickad

26 juni 2026

Först inskickad som uppfyllde QC-kriterierna

6 juli 2026

Första postat (Faktisk)

8 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 260159 (Annan identifierare: City of Hope Medical Center)
  • P30CA033572 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2026-04271 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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