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Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients (SCUSF 1102)

28 januari 2021 bijgewerkt door: University of South Florida

A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients

RATIONALE: Multi-faceted provider education and decision support intervention will increase the rate of appropriate referral of breast cancer patients at increased risk for hereditary breast and ovarian cancer (HBOC) to genetic counseling.

PURPOSE: This cluster randomized controlled trial will compare active and passive interventions to increase the rate of appropriate genetic counseling referrals of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in the community oncology setting.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Approximately 5-10% of all breast cancer patients have hereditary breast cancer, the majority due to an inherited mutation in the BRCA1 or BRCA2 genes (BRCA mutation carriers). Breast cancer patients who are BRCA mutation carriers have up to a 65% risk for a new primary breast cancer in the future. Additionally, BRCA mutation carriers have a 10-45% lifetime risk for ovarian cancer.

Effective options to decrease these high future cancer risks are available to breast cancer patients who learn they carry a BRCA mutation - including prophylactic mastectomy and oophorectomy. Prophylactic mastectomy and oophorectomy reduce the risks for future primary breast cancer and ovarian cancer, respectively, by more than 90%. Because of the high risks for future cancer and the opportunity for effective risk reduction among mutation carriers, national guidelines consistently recommend referral of breast cancer patients at increased risk for hereditary breast cancer and ovarian cancer (HBOC) to genetic counseling by a qualified genetics professional. Lack of implementation of this standard of care constitutes an error of omission and jeopardizes patient outcomes.

We propose a cluster randomized controlled trial to compare a "passive intervention" - dissemination of professional guidelines - with an "active intervention" - a multi-faceted provider education and decision support intervention to improve 1) appropriate referral of breast cancer patients at risk for HBOC to genetic counseling in the community cancer center setting and 2) pre-surgical referral among newly diagnosed patients. Ultimately, these results will lead to decreased breast and ovarian cancer incidence and mortality among breast cancer patients and their family members, as well as improved outcomes of and satisfaction with surgical decision-making.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

3780

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Florida
      • Tampa, Florida, Verenigde Staten, 33612
        • SunCoast CCOP Research Base

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Participant Inclusion Criteria:

  • Females 18 years of age or greater
  • Newly diagnosed primary breast cancer prior to initial definitive surgical treatment, including In situ and Invasive cancer, Stages 0 - III. Pathologic confirmation of diagnosis is required.
  • Able to read and write in English or Spanish

Participant Exclusion Criteria:

  • Any previous diagnosis of cancer except for non-melanoma skin cancer
  • Stage IV breast cancer
  • Received HBOC genetic counseling or mutation testing prior to diagnosis. If the patient was previously tested only for a variant of uncertain clinical significance (i.e., not for known familial mutation, Jewish ethnicity panel/Multisite 3 or comprehensive sequencing) and documentation is provided, they remain eligible.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Active Provider Intervention
Participating Sites assigned to the active intervention cluster will receive a multi-faceted provider education and decision support intervention to improve 1) appropriate referral of breast cancer patients at risk for HBOC to genetic counseling in the community cancer center setting and 2) pre-surgical referral among newly diagnosed patients. They will also receive the National Comprehensive Cancer Network (NCCN) guidelines and Commission on Cancer definition of qualified genetics professional.
Ander: Active Provider Intervention
Participating Sites assigned to the active intervention cluster will receive a multi-faceted provider education and decision support intervention to improve appropriate referral of breast cancer patients at risk for HBOC to genetic counseling and pre-surgical referral among newly diagnosed patients.
Andere namen:
  • Active Genetic Counseling Provider Intervention
Geen tussenkomst: Passive Provider Intervention
Participating Sites assigned to the passive intervention cluster will only receive the National Comprehensive Cancer Network (NCCN) guidelines and Commission on Cancer definition of qualified genetics professional.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of appropriate referral of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in Active vs. Passive Intervention Clusters
Tijdsspanne: 1 year post diagnosis
Site providers will be randomized and receive either the active or passive genetic counseling intervention. Post intervention, site providers will maintain a database of all newly diagnosed breast cancer patients that meet the study eligibility criteria. One year post diagnosis, subjects will be mailed an informed consent form including questionnaires from their providers. Returned patient questionnaire data along with information provided directly from site providers will be utilized to determine the rate of appropriate referral for genetic counseling.
1 year post diagnosis

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of appropriate referral of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in Active vs. Passive Intervention Clusters
Tijdsspanne: 12-15 months post diagnosis

Secondary outcomes will be assessed by patient questionnaire and medical record documentation, where appropriate, and include evaluation of:

  • The rate of pre-surgical referral of appropriate patients to genetic counseling
  • The rate of referral of newly diagnosed breast cancer patients who are not appropriate for genetic counseling referral
  • The rate of genetic counseling uptake
  • The rate of bilateral mastectomy, including the rate of bilateral mastectomy among patients receiving different genetic test results

Psychosocial outcomes:

  • Perceived risk for future primary breast cancer and for ovarian cancer will be assessed
  • Knowledge of hereditary breast and ovarian cancer will be measured
  • Cancer-related distress will be assessed using answers from the patient questionnaire
  • Satisfaction with the decision regarding surgical treatment will be assessed
  • Provider knowledge outcomes from the educational session will also be assessed
12-15 months post diagnosis

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of South Florida

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Rebecca Sutphen, MD, University of South Florida

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2014

Primaire voltooiing (Werkelijk)

1 september 2019

Studie voltooiing (Werkelijk)

1 januari 2020

Studieregistratiedata

Eerst ingediend

7 februari 2013

Eerst ingediend dat voldeed aan de QC-criteria

8 februari 2013

Eerst geplaatst (Schatting)

12 februari 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 februari 2021

Laatste update ingediend die voldeed aan QC-criteria

28 januari 2021

Laatst geverifieerd

1 oktober 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SCUSF 1102 (Andere identificatie: National Cancer Institute)
  • 5U10CA081920 (Subsidie/contract van de Amerikaanse NIH)

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