BREAST-Q REACT Tool for Breast Surgery

Not currently recruiting at 5 trial locations

Overseen By Audree Tadros, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Male, Under 18, Recurrent cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool called BREAST-Q REACT to determine if it can enhance how patients feel and communicate with their doctors after breast surgery. It focuses on quality of life, physical well-being, and how patients manage symptoms and daily activities post-surgery. Participants will either use the new tool for feedback or continue discussing answers to standard questionnaires with their surgeon. Women planning to undergo breast-conserving surgery or mastectomy with reconstruction, who speak English and have internet access, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve post-surgery communication and quality of life for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the BREAST-Q REACT Tool is safe for use in breast surgery patients?

Research shows that the BREAST-Q REACT Tool gathers feedback from patients about their feelings after breast surgery. As it is neither a drug nor a surgical procedure, it does not involve typical safety concerns like side effects. Instead, it enhances communication between patients and doctors regarding recovery and quality of life.

Because the BREAST-Q REACT Tool is non-invasive, no reports indicate it causes harm. It aims to improve conversations rather than provide treatment. Therefore, if considering participation in a trial using this tool, expect a focus on enhancing discussions about well-being after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BREAST-Q REACT Tool because it could transform the feedback process for breast surgery patients. Unlike standard care, which involves discussing feedback with surgeons, this tool offers an additional, structured way to gather and analyze patient-reported outcomes using specific questionnaires before and after surgery. This approach aims to enhance communication between patients and healthcare providers by providing more detailed insights into patient experiences and satisfaction. By offering this extra layer of feedback, the BREAST-Q REACT Tool could lead to improvements in patient care and outcomes.

What evidence suggests that the BREAST-Q REACT Tool is effective for improving quality of life after breast surgery?

Research has shown that the BREAST-Q REACT tool was developed to enhance understanding of BREAST-Q scores and improve patient-focused care. The BREAST-Q survey assesses the impact of breast surgery on aspects such as physical health, pain, and arm movement. In this trial, participants in the intervention group will receive feedback using the BREAST-Q REACT tool from questionnaires completed before and after routine surgery, alongside the usual discussion with their surgeon. Early findings suggest that the tool facilitates understanding of these scores and supports better communication between patients and doctors. The aim is to improve quality of life by addressing specific concerns after surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Jonas Nelson, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals undergoing routine breast conserving surgery or mastectomy. It aims to include those who are willing to use the BREAST-Q REACT tool, which involves completing questionnaires about their physical wellbeing and arm function before and after surgery.

Inclusion Criteria

Able to speak and understand English

I am female.

I am scheduled for breast surgery followed by reconstruction using implants or my own tissue.

Exclusion Criteria

I cannot communicate in English.

My breast cancer has come back.

I am male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 3 months

Treatment

Participants receive feedback using the BREAST-Q REACT tool and discuss it with their surgeon before and after routine breast surgery

up to 3 months

Follow-up

Participants are monitored for quality of life, interactions with doctors, and medical interventions after surgery

up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• BREAST-Q REACT Tool

Trial Overview The study is testing the BREAST-Q REACT tool's effectiveness in improving patients' quality of life, doctor-patient communication, and medical care post-surgery. Participants will provide feedback on physical well-being and arm mobility through standard questionnaires.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

Participants in the intervention group will receive feedback using the BREAST-Q REACT tool from questionnaires completed before and after routine surgery, in addition to the usual way by discussing it with their surgeon.

Group II: Control group Active Control 1 Intervention

Participants in the control group will receive the usual feedback from questionnaires completed before and after routine surgery by discussing it with their surgeon

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

This study established the first normative values for the BREAST-Q breast cancer modules using data from 1201 women, providing a reference point for evaluating patient outcomes after breast cancer surgery and reconstruction.

The findings revealed that women with higher body mass index, larger cup sizes, younger age, and lower income reported lower satisfaction and well-being scores, highlighting the need for tailored support in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. Mundy, LR., Homa, K., Klassen, AF., et al.[2022]

The electronic version of the BREAST-Q, a patient-reported outcome measure for women undergoing breast cancer surgery, demonstrated high reliability and validity based on data from 6748 participants, making it a trustworthy tool for assessing patient satisfaction and quality of life.

With an 82% response rate and low missing data, the BREAST-Q can be effectively used in clinical settings, allowing patients and surgeons to choose between electronic or traditional paper formats for administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the electronic version of the BREAST-Q in the army of women study. Fuzesi, S., Cano, SJ., Klassen, AF., et al.[2019]

The BREAST-Q Implant Surveillance module (BREAST-Q IS) demonstrated good to excellent test-retest reliability among 207 breast implant recipients, indicating it is a reliable tool for assessing patient-reported outcomes in this population.

With a high response rate of 82% for breast augmentation and 94% for breast reconstruction, the study supports the use of BREAST-Q IS in registry settings, although further validation is needed to confirm its overall effectiveness as a patient-reported outcome measure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-Retest Reliability of the BREAST-Q IS in the Australian Breast Device Registry. Merenda, M., Vishwanath, S., Ng, S., et al.[2021]

The implementation of a quality improvement initiative significantly increased the completion rate of the BREAST-Q patient-reported outcome measure from 42.8% to 87.6% between 2011-2019, demonstrating improved patient engagement in breast reconstruction assessments.

The initiative utilized digital tools and assigned 'BREAST-Q Champions' to enhance workflow and accountability, suggesting that similar strategies could be effective in other healthcare settings to integrate patient-reported outcomes into routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving towards patient-reported outcomes in routine clinical practice: implementation lessons from the BREAST-Q. Nelson, JA., Chu, JJ., Dabic, S., et al.[2023]

The BREAST-Q tool has been increasingly utilized in breast surgery research, with 270 studies identified since 2015, highlighting its importance in measuring patient-reported outcomes and satisfaction.

Despite its growing use, there are still significant gaps in understanding the patient experience, indicating a need for more comprehensive data collection to enhance patient-centered care in breast surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of the Application of BREAST-Q in Surgical Research. Arora, N., Patel, R., Sohi, G., et al.[2023]

In a study of 88 patients undergoing implant-based breast reconstruction, significant improvements were reported in satisfaction with breast appearance and psychosocial well-being after surgery, as measured by the BREAST-Q survey.

Overall patient satisfaction with care was high, although physical well-being related to the chest did not show the same level of improvement, indicating areas for potential focus in post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measurements in post-mastectomy implant-based breast reconstruction and radiotherapy: Analysis of BREAST-Q data. Sala, L., Bonomi, S., Ciniselli, CM., et al.[2023]

A study involving 107 women who underwent breast reduction surgery showed significant improvements in quality of life and patient satisfaction at both 1 and 6 months post-surgery, as measured by the BREAST-Q™ survey.

Patients reported enhanced psychosocial, sexual, and physical well-being, with high satisfaction rates regarding their surgical outcomes, indicating that reduction mammaplasty is effective in improving overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the BREAST-Q™ Survey in the Prospective Evaluation of Reduction Mammaplasty Outcomes. Cabral, IV., da Silva Garcia, E., Sobrinho, RN., et al.[2022]

The BREAST-Q is a validated patient-reported outcome tool for assessing the impact of cosmetic and reconstructive breast surgery, based on a study involving 817 women with a 66% response rate.

Rasch analysis and traditional psychometric methods confirmed the tool's construct and clinical validity, showing it effectively captures a wide range of patient experiences and has high reliability, making it suitable for clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BREAST-Q: further validation in independent clinical samples. Cano, SJ., Klassen, AF., Scott, AM., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11798000/

BREAST-Q REACT: Qualitative Assessment of the Design ... The BREAST-Q Real-time Engagement and Communication Tool (REACT) was developed to aid with BREAST-Q score interpretation and guide patient-centered care.

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-07004

Real-time Engagement and Communication Tool (BREAST ... The BREAST-Q is a patient-reported outcome questionnaire that provides information about the impact and effectiveness of breast surgery. BREAST-Q REACT, an ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06550401

A Study of the BREAST-Q REACT Tool for People Having ... The BREAST-Q REACT tool shows scores from standard questionnaires completed before and after breast surgery about overall physical wellbeing, arm pain or ...

4. link.springer.com link.springer.com/article/10.1245/s10434-024-15185-0

BREAST-Q REACT: Qualitative Assessment of the Design, ... The BREAST-Q real-time engagement and communication tool (REACT) was developed to aid with BREAST-Q score interpretation and guide patient-centered care.

5. qportfolio.org qportfolio.org/breast-q/

BREAST-Q | Q-Portfolio - MEASURING WHAT MATTERS ... The BREAST-Q has separate modules for breast cancer, augmentation, and reduction/mastopexy. Each module is composed of multiple independently functioning ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35415816/

BREAST-Q REACT: Clinical Reference Values for ... - PubMed The aim of this study was to define reference values for the BREAST-Q at discrete timepoints following surgery, generating a tool for real-time score ...

7. withpower.com withpower.com/trial/phase-breast-conserving-surgery-7-2024-1a468

BREAST-Q REACT Tool for Breast Surgery The BREAST-Q REACT Tool is unique because it focuses on collecting patient-reported outcomes (PROs) to enhance patient-centered care in breast surgery. Unlike ...