Clinical trial · Interventional
Genetic Counseling or Usual Care in Helping Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I, Stage II, or Stage IIIA Breast Cancer Make Treatment Decisions
Genetic Counseling for Newly Diagnosed Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Genetics education and counseling may help patients make treatment decisions. It is not yet known how genetic counseling or usual care influence patient treatment decisions for breast cancer. PURPOSE: This randomized clinical trial is studying how well genetic counseling works compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ, stage I, stage II, or stage IIIA breast cancer make treatment decisions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Behavioral | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rapid genetic counseling
- description
- Following randomization, participants will be informed about whether they are assigned to Usual Care (UC) or Rapid Genetic Counseling (RGC). Participants in the UC arm can schedule a genetic counseling appointment at any time during the study if they wish. Participants in the RGC agree to obtain genetic counseling as soon as possible, before they make a definitive surgery decision. RGC can be accomplished by telephone or in-person. The RGC intervention is delivered by highly experienced genetic counselors at each site. This counseling is identical to our standard genetic counseling procedure for newly diagnosed patients. Immediate DNA collection via blood or buccal cell collection is available following counseling. Phone counseling participants will be been mailed a kit for DNA collection or have the option of having the sample collected at at LCCC.
- interventionNames
- Behavioral: counseling intervention
- Other: educational intervention
- Procedure: psychosocial assessment and care
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Usual Care (UC) for newly diagnosed breast cancer patients does not typically include a pre-surgical genetic referral. These patients may obtain genetic counseling at their own discretion.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Newly diagnosed breast cancer, meeting 1 of the following criteria:
* Stage 0 disease (ductal carcinoma in situ only)
* Stage I-IIIA disease
* Must meet 1 of the following criteria:
* Diagnosis before 50 years of age
* Diagnosis after 50 years of age AND has 1 of the following:
* First or second degree relative diagnosed with breast cancer before 50 years of age
* First or second degree relative diagnosed with ovarian cancer at any age
* First or second degree relative diagnosed with male breast cancer at any age
* Must not have initiated definitive treatment for breast cancer
* No bilateral, metastatic, or inflammatory breast cancer
* No prior BRCA1/2 counseling or testing
* No prior diagnosis of metastatic cancer of any type
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Sex
* Female
Menopausal status
* Not specified
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
PRIOR CONCURRENT THERAPY:
Surgery
* No prior bilateral mastectomy for breast cancer
Other
* No concurrent treatment for cancerReferences
Publications (1)
- DERIVEDSchwartz MD, Peshkin BN, Isaacs C, Willey S, Valdimarsdottir HB, Nusbaum R, Hooker G, O'Neill S, Jandorf L, Kelly SP, Heinzmann J, Zidell A, Khoury K. Randomized trial of proactive rapid genetic counseling versus usual care for newly diagnosed breast cancer patients. Breast Cancer Res Treat. 2018 Aug;170(3):517-524. doi: 10.1007/s10549-018-4773-3. Epub 2018 Apr 2. PMID 29611029