Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799951
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2020-05-26
Brief Title:
A Survey to Assess Knowledge Attitudes Practices in Surgeons With Regards to Breast Conservation Surgery Mastectomy
Sponsor:
Tata Memorial Centre
Organization:
Tata Memorial Centre
Study Overview
Official Title:
A Survey to Assess Knowledge Attitudes and Practices Amongst Surgeons With Regards to Breast Conservation Surgery and Mastectomy
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 BCSbreast 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 Surgeons recommendations are considered as important as patients perception of body image issues while making the decision Surgeons recommendations are usually based on their knowledge and belief regarding patients disease characteristics and their perceptions regarding patients 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
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 Surgeons recommendations are considered as important as patients perception of body image issues while making the decision Surgeons recommendations are usually based on their knowledge and belief regarding patients disease characteristics and their perceptions regarding patients 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
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 womens 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 Fishers 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 126 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 Surgeons recommendations are considered as important as patients perception of body image issues while making the decision Surgeons recommendations are usually based on their knowledge and belief regarding patients disease characteristics and their perceptions regarding patients socioeconomic capabilities and perceived compliance to prescribed treatment plan We intend to study surgeons and patients 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 consultationRandomized 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 003 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 patients 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 degreecountry 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 126 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 Surgeons recommendations are considered as important as patients perception of body image issues while making the decision Surgeons recommendations are usually based on their knowledge and belief regarding patients disease characteristics and their perceptions regarding patients socioeconomic capabilities and perceived compliance to prescribed treatment plan
We intend to study surgeons perspective regarding the decision making by administering a questionnaire to themAim of this study is to understand knowledge attitude and practices of primary surgeons regarding breast conservation surgery vs mastectomy in treatment of breast cancer
Interestingly Barron Lerner observed the convergence of the womens 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 Fishers 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 126 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 Surgeons recommendations are considered as important as patients perception of body image issues while making the decision Surgeons recommendations are usually based on their knowledge and belief regarding patients disease characteristics and their perceptions regarding patients socioeconomic capabilities and perceived compliance to prescribed treatment plan We intend to study surgeons and patients 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 consultationRandomized 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 003 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 patients 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 degreecountry 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 126 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 Surgeons recommendations are considered as important as patients perception of body image issues while making the decision Surgeons recommendations are usually based on their knowledge and belief regarding patients disease characteristics and their perceptions regarding patients socioeconomic capabilities and perceived compliance to prescribed treatment plan
We intend to study surgeons perspective regarding the decision making by administering a questionnaire to themAim 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None