BREAST-Q REACT Tool for Breast Surgery

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

69 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The researchers are doing this study to find out whether it is practical (feasible) to conduct a larger study looking at the effects of the BREAST-Q Real-time Engagement and Communication Tool (REACT) on people's quality of life, interactions with their doctors, and medical interventions after undergoing routine breast conserving surgery or mastectomy. The BREAST-Q REACT tool shows scores from standard questionnaires completed before and after breast surgery about overall physical wellbeing, arm pain or tightness, the ability to move the arms and perform everyday tasks, and any symptoms related to the arms, and provides feedback including recommendations and detailed information that help explain these scores and guide topics for people and their doctor to discuss.

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.

Is the BREAST-Q REACT Tool safe for use in humans?

The available research does not provide specific safety data for the BREAST-Q REACT Tool, as it primarily focuses on its use as a patient-reported outcome measure in breast surgery. ^{1 2 3 4 5}

Is the BREAST-Q REACT Tool safe for use in humans?

The available research does not provide specific safety data for the BREAST-Q REACT Tool, as it primarily focuses on its use as a patient-reported outcome measure in breast surgery. ^{1 2 3 4 5}

How is the BREAST-Q REACT Tool treatment different from other treatments 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 traditional treatments, it emphasizes real-time engagement and communication to improve satisfaction and quality of life for patients undergoing breast surgery. ^{1 2 3 5 6}

How is the BREAST-Q REACT Tool treatment different from other treatments 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 traditional treatments that may not prioritize real-time patient feedback. This tool helps measure patient satisfaction and quality of life, providing valuable insights for personalized treatment decisions. ^{1 2 3 5 6}

What data supports the effectiveness of the BREAST-Q REACT Tool treatment for breast surgery?

The BREAST-Q tool is widely recognized as a gold standard for measuring patient-reported outcomes in breast surgery, helping to ensure care is patient-centered and evidence-based. It has been effectively used to assess patient experiences and outcomes in breast reconstruction and other related procedures, indicating its utility in improving patient engagement and satisfaction. ^{1 4 5 7 8}

What data supports the effectiveness of the BREAST-Q REACT Tool treatment for breast surgery?

The BREAST-Q is widely recognized as a gold-standard tool for collecting patient-reported outcomes in breast surgery, which helps improve patient-centered care by capturing patients' experiences and satisfaction. This tool has been effectively used in various studies to assess outcomes in breast reconstruction and surgery, indicating its utility in enhancing communication and engagement with patients. ^{1 4 5 7 8}

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

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]

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]

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]

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 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 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 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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

A Scoping Review of the Application of BREAST-Q in Surgical Research. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Test-Retest Reliability of the BREAST-Q IS in the Australian Breast Device Registry. [2021]

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

Patient-reported outcome measurements in post-mastectomy implant-based breast reconstruction and radiotherapy: Analysis of BREAST-Q data. [2023]

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

Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Moving towards patient-reported outcomes in routine clinical practice: implementation lessons from the BREAST-Q. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Validation of the electronic version of the BREAST-Q in the army of women study. [2019]

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

The BREAST-Q: further validation in independent clinical samples. [2022]

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

Use of the BREAST-Q™ Survey in the Prospective Evaluation of Reduction Mammaplasty Outcomes. [2022]