Health Personnel AttitudeNCT04799951
A Survey to Assess Knowledge, Attitudes & Practices in Surgeons With Regards to Breast Conservation Surgery & Mastectomy
An observational study of Health Personnel Attitude and Health Knowledge, Attitudes, Practice, run by Tata Memorial Centre at 1 site in India.
Trial 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 BCS(breast conservative surgeries) in suitable patients with early breast cancer, a significant percentage of women in India… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Personnel Attitude, Health Knowledge, Attitudes, Practice
- What is being tested?
- a survey questionnaire to find knowledge, attitude and practices in treatment of breast cancer.
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- 2 Apr 2019to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All Surgeon having experience in and working in Breast oncological surgeries
Who cannot join
- Not Any
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- a survey questionnaire to find knowledge, attitude and practices in treatment of breast cancer.
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a survey questionnaire to find knowledge, attitude and practices in treatment of breast cancer.Other
an electronic webbased survey to assess knowledge, attitudes and practices amongst surgeons with regards to breast conservation surgery and mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Breast Surgeon | surgeons having experience in and regularly conducting breast conservation surgery and mastectomy surgeries Receives: Other: a survey questionnaire to find knowledge, attitude and practices in treatment of breast cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge, attitudes and practices of surgeon with regards to breast conservation surgery and mastectomy
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start2 Apr 2019
- Primary completion30 Sep 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Health Personnel AttitudeStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nita Sukumar Nair, Tata Memorial Centre
- Investigators
- Nita Nair, MCH, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799951
- Sponsor's protocol ID
- 3212
- Status last verified
- Mar 2021
- First submitted
- 26 May 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As per IEC mandate all data and responses will be kept anonymous hence will not be shared with anyone.
Publications
Bellavance EC, Kesmodel SB. Decision-Making in the Surgical Treatment of Breast Cancer: Factors Influencing Women's Choices for Mastectomy and Breast Conserving Surgery. Front Oncol. 2016 Mar 29;6:74. doi: 10.3389/fonc.2016.00074. eCollection 2016.
PubMed 27066455NIH consensus conference. Treatment of early-stage breast cancer. JAMA. 1991 Jan 16;265(3):391-5. No abstract available.
PubMed 1984541Gomez SL, Lichtensztajn D, Kurian AW, Telli ML, Chang ET, Keegan TH, Glaser SL, Clarke CA. Increasing mastectomy rates for early-stage breast cancer? Population-based trends from California. J Clin Oncol. 2010 Apr 1;28(10):e155-7; author reply e158. doi: 10.1200/JCO.2009.26.1032. Epub 2010 Feb 16. No abstract available.
PubMed 20159812Lautner M, Lin H, Shen Y, Parker C, Kuerer H, Shaitelman S, Babiera G, Bedrosian I. Disparities in the Use of Breast-Conserving Therapy Among Patients With Early-Stage Breast Cancer. JAMA Surg. 2015 Aug;150(8):778-86. doi: 10.1001/jamasurg.2015.1102.
PubMed 26083835Freedman RA, Virgo KS, Labadie J, He Y, Partridge AH, Keating NL. Receipt of locoregional therapy among young women with breast cancer. Breast Cancer Res Treat. 2012 Oct;135(3):893-906. doi: 10.1007/s10549-012-2156-8. Epub 2012 Sep 5.
PubMed 22949130Cao JQ, Olson RA, Tyldesley SK. Comparison of recurrence and survival rates after breast-conserving therapy and mastectomy in young women with breast cancer. Curr Oncol. 2013 Dec;20(6):e593-601. doi: 10.3747/co.20.1543.
PubMed 24311961Ye JC, Yan W, Christos PJ, Nori D, Ravi A. Equivalent Survival With Mastectomy or Breast-conserving Surgery Plus Radiation in Young Women Aged < 40 Years With Early-Stage Breast Cancer: A National Registry-based Stage-by-Stage Comparison. Clin Breast Cancer. 2015 Oct;15(5):390-7. doi: 10.1016/j.clbc.2015.03.012. Epub 2015 Apr 2.
PubMed 25957740Smith GL, Xu Y, Shih YC, Giordano SH, Smith BD, Hunt KK, Strom EA, Perkins GH, Hortobagyi GN, Buchholz TA. Breast-conserving surgery in older patients with invasive breast cancer: current patterns of treatment across the United States. J Am Coll Surg. 2009 Oct;209(4):425-433.e2. doi: 10.1016/j.jamcollsurg.2009.06.363. Epub 2009 Aug 20.
PubMed 19801315Chagpar AB, Studts JL, Scoggins CR, Martin RC 2nd, Carlson DJ, Laidley AL, El-Eid SE, McGlothin TQ, Noyes RD, McMasters KM. Factors associated with surgical options for breast carcinoma. Cancer. 2006 Apr 1;106(7):1462-6. doi: 10.1002/cncr.21728.
PubMed 16470610Morrow M, White J, Moughan J, Owen J, Pajack T, Sylvester J, Wilson JF, Winchester D. Factors predicting the use of breast-conserving therapy in stage I and II breast carcinoma. J Clin Oncol. 2001 Apr 15;19(8):2254-62. doi: 10.1200/JCO.2001.19.8.2254.
PubMed 11304779Staradub VL, Hsieh YC, Clauson J, Langerman A, Rademaker AW, Morrow M. Factors that influence surgical choices in women with breast carcinoma. Cancer. 2002 Sep 15;95(6):1185-90. doi: 10.1002/cncr.10824.
PubMed 12216083Churilla TM, Donnelly PE, Leatherman ER, Adonizio CS, Peters CA. Total Mastectomy or Breast Conservation Therapy? How Radiation Oncologist Accessibility Determines Treatment Choice and Quality: A SEER Data-base Analysis. Breast J. 2015 Sep-Oct;21(5):473-80. doi: 10.1111/tbj.12449. Epub 2015 Jul 2.
PubMed 26133235Nold RJ, Beamer RL, Helmer SD, McBoyle MF. Factors influencing a woman's choice to undergo breast-conserving surgery versus modified radical mastectomy. Am J Surg. 2000 Dec;180(6):413-8. doi: 10.1016/s0002-9610(00)00501-8.
PubMed 11182389Ganz PA, Schag AC, Lee JJ, Polinsky ML, Tan SJ. Breast conservation versus mastectomy. Is there a difference in psychological adjustment or quality of life in the year after surgery? Cancer. 1992 Apr 1;69(7):1729-38. doi: 10.1002/1097-0142(19920401)69:73.0.co;2-d.
PubMed 1551058Narendra H, Ray S. Breast conserving surgery for breast cancer: single institutional experience from Southern India. Indian J Cancer. 2011 Oct-Dec;48(4):415-22. doi: 10.4103/0019-509X.92260.
PubMed 22293254
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey to Assess Knowledge, Attitudes and Practices Amongst Surgeons With Regards to Breast Conservation Surgery and Mastectomy
- ClinicalTrials.gov ID
- NCT04799951
- Acronym / sponsor ID
- 3212
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Surgeon | – | Other: a survey questionnaire to find knowledge, attitude and practices in treatment of breast cancer.surgeons having experience in and regularly conducting breast conservation surgery and mastectomy surgeries |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All Surgeon having experience in and working in Breast oncological surgeries
Key exclusion criteria (1 listed)
- Not Any
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Breast Surgeon |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Background: PubMed 27066455Bellavance EC, Kesmodel SB. Decision-Making in the Surgical Treatment of Breast Cancer: Factors Influencing Women's Choices for Mastectomy and Breast Conserving Surgery. Front Oncol. 2016 Mar 29;6:74. doi: 10.3389/fonc.2016.00074. eCollection 2016.
- Background: PubMed 1984541NIH consensus conference. Treatment of early-stage breast cancer. JAMA. 1991 Jan 16;265(3):391-5. No abstract available.
- Background: PubMed 20159812Gomez SL, Lichtensztajn D, Kurian AW, Telli ML, Chang ET, Keegan TH, Glaser SL, Clarke CA. Increasing mastectomy rates for early-stage breast cancer? Population-based trends from California. J Clin Oncol. 2010 Apr 1;28(10):e155-7; author reply e158. doi: 10.1200/JCO.2009.26.1032. Epub 2010 Feb 16. No abstract available.
- Background: PubMed 26083835Lautner M, Lin H, Shen Y, Parker C, Kuerer H, Shaitelman S, Babiera G, Bedrosian I. Disparities in the Use of Breast-Conserving Therapy Among Patients With Early-Stage Breast Cancer. JAMA Surg. 2015 Aug;150(8):778-86. doi: 10.1001/jamasurg.2015.1102.
- Background: PubMed 22949130Freedman RA, Virgo KS, Labadie J, He Y, Partridge AH, Keating NL. Receipt of locoregional therapy among young women with breast cancer. Breast Cancer Res Treat. 2012 Oct;135(3):893-906. doi: 10.1007/s10549-012-2156-8. Epub 2012 Sep 5.
- Background: PubMed 24311961Cao JQ, Olson RA, Tyldesley SK. Comparison of recurrence and survival rates after breast-conserving therapy and mastectomy in young women with breast cancer. Curr Oncol. 2013 Dec;20(6):e593-601. doi: 10.3747/co.20.1543.
- Background: PubMed 25957740Ye JC, Yan W, Christos PJ, Nori D, Ravi A. Equivalent Survival With Mastectomy or Breast-conserving Surgery Plus Radiation in Young Women Aged < 40 Years With Early-Stage Breast Cancer: A National Registry-based Stage-by-Stage Comparison. Clin Breast Cancer. 2015 Oct;15(5):390-7. doi: 10.1016/j.clbc.2015.03.012. Epub 2015 Apr 2.
- Background: PubMed 19801315Smith GL, Xu Y, Shih YC, Giordano SH, Smith BD, Hunt KK, Strom EA, Perkins GH, Hortobagyi GN, Buchholz TA. Breast-conserving surgery in older patients with invasive breast cancer: current patterns of treatment across the United States. J Am Coll Surg. 2009 Oct;209(4):425-433.e2. doi: 10.1016/j.jamcollsurg.2009.06.363. Epub 2009 Aug 20.
- Background: PubMed 16470610Chagpar AB, Studts JL, Scoggins CR, Martin RC 2nd, Carlson DJ, Laidley AL, El-Eid SE, McGlothin TQ, Noyes RD, McMasters KM. Factors associated with surgical options for breast carcinoma. Cancer. 2006 Apr 1;106(7):1462-6. doi: 10.1002/cncr.21728.
- Background: PubMed 11304779Morrow M, White J, Moughan J, Owen J, Pajack T, Sylvester J, Wilson JF, Winchester D. Factors predicting the use of breast-conserving therapy in stage I and II breast carcinoma. J Clin Oncol. 2001 Apr 15;19(8):2254-62. doi: 10.1200/JCO.2001.19.8.2254.
- Background: PubMed 12216083Staradub VL, Hsieh YC, Clauson J, Langerman A, Rademaker AW, Morrow M. Factors that influence surgical choices in women with breast carcinoma. Cancer. 2002 Sep 15;95(6):1185-90. doi: 10.1002/cncr.10824.
- Background: PubMed 26133235Churilla TM, Donnelly PE, Leatherman ER, Adonizio CS, Peters CA. Total Mastectomy or Breast Conservation Therapy? How Radiation Oncologist Accessibility Determines Treatment Choice and Quality: A SEER Data-base Analysis. Breast J. 2015 Sep-Oct;21(5):473-80. doi: 10.1111/tbj.12449. Epub 2015 Jul 2.
- Individual participant dataSharing planned: No. As per IEC mandate all data and responses will be kept anonymous hence will not be shared with anyone.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nita Nair, MCH principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Personnel Attitude and Health Knowledge, Attitudes, Practice, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge, attitudes and practices of surgeon with regards to breast conservation surgery and mastectomy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04799951, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.