A Survey to Assess Knowledge, Attitudes & Practices in Surgeons With Regards to Breast Conservation Surgery & Mastectomy

March 15, 2021 updated by: Nita Sukumar Nair, Tata Memorial Centre

A Survey to Assess Knowledge, Attitudes and Practices Amongst Surgeons With Regards to Breast Conservation Surgery and Mastectomy

With increasing evidence the management of breast cancer surgery has seen a paradigm shift towards breast conservation, heralding an era of oncoplastic breast surgery. Despite data supporting BCS(breast conservative surgeries) in suitable patients with early breast cancer, a significant percentage of women in India who would be candidates for BCS still decide to undergo mastectomy. The factors that influence these treatment decisions are complex and involve issues regarding access to health care, concerns for cancer recurrence, and the impact of surgery on body image and sexuality.

Surgeon plays an important role in patient selection for breast conservation based on clinico-pathological characters, explaining to patient regarding mandatory locoregional radiotherapy and regular follow up, helping patient make an informed decision by providing safety and outcome profile as compared to mastectomy. Surgeon's recommendations are considered as important as patient's perception of body image issues, while making the decision. Surgeon's recommendations are usually based on their knowledge and belief regarding patient's disease characteristics and their perceptions regarding patient's socioeconomic capabilities and perceived compliance to prescribed treatment plan.

Hence we are conducting this web based e-survey in surgeons from Private hospitals (breast specific practice) Medical colleges and Regional Cancer Centers (RCC) with an aim to evaluate the to understand knowledge, attitude and practices of primary surgeons regarding breast conservation surgery Vs mastectomy in treatment of breast cancer.

We plan to administer the questionnaire to approximately 100 surgeons, equally distributed within aforementioned sectors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With increasing evidence the management of breast cancer surgery has seen a paradigm shift towards breast conservation, heralding an era of oncoplastic breast surgery. Despite data supporting BCS in suitable patients with early breast cancer, a significant percentage of women in India who would be candidates for BCS still decide to undergo mastectomy. The factors that influence these treatment decisions are complex and involve issues regarding access to health care, concerns for cancer recurrence, and the impact of surgery on body image and sexuality.

Interestingly, Barron Lerner observed the convergence of the women's liberation movement and the rise of Breast Conservation Surgery as the standard of surgical care in the treatment of early stage disease, implying that the felt need of breast conservation was important in stimulating research into breast conservation. One celebrated example of such demand was, writer Rosamond Babette who refused radical mastectomy when diagnosed with breast cancer in 1971 and sought Bernard Fisher's expertise, who, in that era was offering partial mastectomy for early breast cancer. There is now Level I evidence favoring breast conservation surgery for early breast cancer. Decision of breast conservation surgery or mastectomy for early breast cancer, is based on the clinico-pathological factors, individual factors and physician factors. Each has its influence on the decision; making the decision process complex one.

Age of patient at presentation is important factor and it appears logical that younger patients would prefer breast conservation over mastectomy. Two reviews of the National Cancer Database have demonstrated that on the background of increased numbers of breast conservation younger patients are being treated with mastectomy at higher rates than their older counterparts after adjusting for patient, facility, and tumor characteristics. The subset of women aged ≤ 35 years were twice as likely to undergo mastectomy compared to women aged 61-64 years. These studies also reported similar trends with socioeconomic status, geography, and cancer stage. It is unclear why younger women may be opting for more extensive surgery. This may be due to a concern for locoregional recurrence in younger patients, although more aggressive surgery does not appear to affect breast cancer-specific survival.

Availability of radiation facilities and patients' compliance has been studied in detail with reference to breast conservation. It has been seen that breast conservation rates are higher in tertiary care centers with easy accessibility to radiation facilities and within those patients who stay close by to radiation facilities.

country of training, gender, or number of procedures. These studies suggested female gender, higher case number, training, and individual surgeon practice were associated with increased BCT rates.

TMH Mumbai reports that the proportion of cases undergoing BCS has shown a significant upward trend from 12.6% in 1997 to 70% at present. However at institutes across India BCS rates quoted are less than 30%. Surgeon plays an important role in patient selection for breast conservation based on clinicopathological characters, explaining to patient regarding mandatory locoregional radiotherapy and regular follow up, helping patient make an informed decision by providing safety and outcome profile as compared to mastectomy. Surgeon's recommendations are considered as important as patient's perception of body image issues, while making the decision. Surgeon's recommendations are usually based on their knowledge and belief regarding patient's disease characteristics and their perceptions regarding patient's socioeconomic capabilities and perceived compliance to prescribed treatment plan. We intend to study surgeon's and patient's perspective regarding the decision making, by administering a questionnaire to them.

In an attempt to provide all valid information in easily understandable language and in disambiguous manner various decision making aides have been prepared and studies. In one such study, patients and surgeons were interviewed to identify key factors influencing breast cancer surgery decisions. They were then incorporated into a decision board that could be reviewed at the time of surgical consultation.Randomized trial comparing the decision board to usual care demonstrated that patients who had surgical consultations with the decision board had higher knowledge scores regarding treatment options; less decisional conflict and were more satisfied with the decision-making process. In addition, patients in the decision board group were more likely to undergo BCS (94 vs. 76%, P = 0.03). Recent meta-analysis of studies using decision aids in breast cancer patients, demonstrated that women were 25% more likely to choose BCS over mastectomy if a decision aid was utilized.

Nine studies examined how physician related factors influenced patient's choice of mastectomy versus BCT. The variables reported included comparing individual surgeons' numbers of breast conservations, medical oncology consultation, and specific surgeon demographics such as degree,country of training, gender, or number of procedures. These studies suggested female gender, higher case number, training, and individual surgeon practice were associated with increased BCT rates.

TMH Mumbai reports that the proportion of cases undergoing BCS has shown a significant upward trend from 12.6% in 1997 to 70% at present. However at institutes across India BCS rates quoted are less than 30%. Surgeon plays an important role in patient selection for breast conservation based on clinicopathological characters, explaining to patient regarding mandatory locoregional radiotherapy and regular follow up, helping patient make an informed decision by providing safety and outcome profile as compared to mastectomy. Surgeon's recommendations are considered as important as patient's perception of body image issues, while making the decision. Surgeon's recommendations are usually based on their knowledge and belief regarding patient's disease characteristics and their perceptions regarding patient's socioeconomic capabilities and perceived compliance to prescribed treatment plan.

We intend to study surgeon's perspective regarding the decision making, by administering a questionnaire to them.Aim of this study is to understand knowledge, attitude and practices of primary surgeons regarding breast conservation surgery vs mastectomy in treatment of breast cancer.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We plan to administer a questionnaire to surgeons working in Private hospital (brest Specific practice) Medical Colleges and Regional cancer centers sectors to gain the relevant information.

We plan to administer the questionnaire to approximately 100 surgeons.

Description

Inclusion Criteria:

  • All Surgeon having experience in and working in Breast oncological surgeries

Exclusion Criteria:

  • Not Any

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Surgeon
surgeons having experience in and regularly conducting breast conservation surgery and mastectomy surgeries
Other: a survey questionnaire to find knowledge, attitude and practices in treatment of breast cancer.
an electronic webbased survey to assess knowledge, attitudes and practices amongst surgeons with regards to breast conservation surgery and mastectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knowledge, attitudes and practices of surgeon with regards to breast conservation surgery and mastectomy
Time Frame: 1 year
to access the knowledge, attitudes and practices of surgeon to study surgeon's and patient's perspective regarding the decision making, by administering a questionnaire to them.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Centre

Investigators

  • Principal Investigator: Nita Nair, MCH, Tata Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2019

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 3212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As per IEC mandate all data and responses will be kept anonymous hence will not be shared with anyone.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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