Patient-Reported Outcomes After Breast Biopsy

Recruiting at 5 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Invasive breast cancer, Other cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

912 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial looks at how women feel after a breast biopsy, focusing on those with certain breast conditions. The goal is to help women and doctors make better care decisions based on these experiences.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is a breast biopsy generally safe for humans?

A study compared complication rates of core needle breast biopsy in patients with and without anticoagulation therapy (blood-thinning medication), suggesting that the procedure is generally safe, even for those on such medication. ^{1 2 3 4 5}

How does this treatment differ from other breast biopsy treatments?

This treatment focuses on patient-reported outcomes after breast biopsy, emphasizing patient perceptions and satisfaction with the timing and type of biopsy procedure, which is unique compared to other treatments that may not prioritize patient feedback in the same way. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Survey for improving patient-reported outcomes after breast biopsy?

The research suggests that reducing wait times for breast biopsy results can improve patient satisfaction and reduce anxiety, which are important aspects of patient-reported outcomes. Implementing faster diagnostic pathways has been shown to enhance the overall patient experience. ^{1 2 6 8 9}

Who Is on the Research Team?

Ann H. Partridge, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults who've had a breast biopsy showing atypical lesions and have been treated at certain study sites. They must be able to read English or Spanish, provide consent, and have at least one year of follow-up data post-diagnosis. Those with other cancers within the last five years or invasive breast cancer ever are excluded.

Inclusion Criteria

I was treated for early breast changes at a specified hospital.

Able to read either English or Spanish and able to provide written (via paper), or on-line informed consent

I was 18 or older when my condition was first diagnosed.

Exclusion Criteria

I have been diagnosed with invasive or microinvasive breast cancer before.

I have not been diagnosed with any cancer other than non-melanoma skin cancer in the last 5 years.

Patients identified by treating physician as being unsuitable for contact

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Survey Administration

Participants complete the Patient-reported Outcomes Survey online, over the phone, or via mail

1-2 weeks

Follow-up

Participants are monitored for patient-reported outcomes, including severity of chronic pain, over an extended period

45.8 months

What Are the Treatments Tested in This Trial?

Interventions

• Survey

Trial Overview The PORTAL study is not testing a drug but rather collecting information through surveys on how patients feel physically and emotionally after treatment for specific non-invasive breast conditions like ADH, ALH, LCIS, or DCIS.

How Is the Trial Designed?

Group I: Patient-reported Outcomes Survey Experimental Treatment 1 Intervention

The survey will administered online, over the phone, or via mail.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Now or Later? - Patient satisfaction and anxiety among women undergoing breast biopsies performed the same day as recommended versus a later day. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Patient perceptions of breast biopsy procedures for screen-detected lesions. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Percutaneous breast biopsy: effect on short-term quality of life. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Compliance with recommended follow-up after fine-needle aspiration biopsy of nonpalpable breast lesions: a retrospective study. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Improving Wait Times and Patient Experience Through Implementation of a Provincial Expedited Diagnostic Pathway for BI-RADS 5 Breast Lesions. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Patient Perceptions of Breast Cancer Risk in Imaging-Detected Low-Risk Scenarios and Thresholds for Desired Intervention: A Multi-Institution Survey. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Communicating biopsy results from breast screening assessment: current practice in English breast screening centres and staff perspectives of telephoning results. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Core needle breast biopsy in patients undergoing anticoagulation therapy: preliminary results. [2008]

9. England pubmed.ncbi.nlm.nih.gov

National survey of B1 and B2 reporting of breast needle core biopsies. [2016]