Patient-Reported Outcomes After Breast Biopsy

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the physical and emotional experiences of individuals after a breast biopsy for conditions like atypical ductal hyperplasia (ADH) or ductal carcinoma in situ (DCIS), which involve unusual cell growths in the breast. The researchers aim to gather personal insights through a survey about the experience and its impact on daily life. The trial seeks participants diagnosed with these specific breast conditions between 2012 and 2017 who received treatment at certain medical centers. Participants should be able to complete a survey in English or Spanish. As an unphased trial, this study offers a unique opportunity for participants to share their experiences and contribute to a better understanding of the emotional and physical impacts of breast biopsies.

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.

What prior data suggests that this survey is safe for participants?

This study examines patient experiences following a breast biopsy by using a survey to collect information. Research has shown that surveys where patients report their own experiences safely gather data. These surveys have often been used in breast cancer studies to better understand treatment effects. Filling out a survey involves no physical risks. Instead, it helps researchers learn about the emotional and physical impacts from the patient's perspective. This method is easy for participants, as it only involves sharing personal experiences, usually online, over the phone, or through mail. Therefore, this approach presents no safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient-reported Outcomes Survey because it offers a fresh perspective on how patients experience breast biopsies, which are typically evaluated through clinical outcomes alone. Traditional approaches focus on physical results and medical data, but this survey prioritizes the patient’s voice and their personal insights, which can lead to more patient-centered care. By collecting and analyzing this feedback, the survey aims to improve the overall experience and potentially guide future improvements in breast biopsy procedures.

What evidence suggests that this survey is effective for evaluating patient-reported outcomes after a breast biopsy?

Research shows that surveys about patients' feelings after breast cancer treatments provide valuable insights. In this trial, participants will complete a Patient-reported Outcomes Survey, capturing both physical and emotional experiences. Studies have found that these patient-reported outcomes enhance understanding of treatment effects on breast cancer patients. They focus on the patient's perspective, making them patient-centered. Although research continues, these surveys increasingly improve care and outcomes for breast cancer patients. ^{1 3 5 6 7}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9613969/

The predictive value of patient-reported outcomes on ... Patient-reported outcomes (PROs) have been widely used to measure breast cancer (BC) treatment outcomes. However, evidence is still limited ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9058781/

Liquid biopsies and patient-reported outcome measures for ... Including patient-reported outcome measures (PROMs) allows for a vast number of possibilities to compare PROM data with biological information, ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.530

Association between patient-reported outcomes and ... Association between patient-reported outcomes and therapeutic outcomes in patients with breast cancer: A pooled individual-participant data ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0960977624001486

Breast-cancer specific comprehensive archive of Patient ... This study developed a breast cancer specific comprehensive archive of PROMs. This tool promotes a patient-centered approach in clinical research and practice.

5. academic.oup.com academic.oup.com/eurpub/article/35/5/835/8186226

patient-reported outcomes for patients diagnosed with breast ... Improvements in breast cancer survival rate have been achieved through a variety of multimodal therapeutic approaches, which play a key role in ...

6. jacr.org jacr.org/article/S1546-1440(25)00251-0/fulltext

Outcomes of Implementation of a Same-Day Breast Biopsy ... Conclusion. Implementation of a SDB program is effective in reducing overall diagnostic delays after a breast biopsy recommendation for patients ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10793790/

Effect of mode of delivery of patient reported outcomes in ... Patient reported outcomes (PROs) have an integral role on how to improve patients' overall experience. The optimal PROs delivery in patients ...