Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT04799951
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2020-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Survey to Assess Knowledge, Attitudes & Practices in Surgeons With Regards to Breast Conservation Surgery & Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'knowledge, attitudes and practices of surgeon with regards to breast conservation surgery and mastectomy', 'timeFrame': '1 year', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Personnel Attitude', 'Health Knowledge, Attitudes, Practice']}, 'referencesModule': {'references': [{'pmid': '27066455', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '1984541', 'type': 'BACKGROUND', 'citation': 'NIH consensus conference. Treatment of early-stage breast cancer. JAMA. 1991 Jan 16;265(3):391-5. No abstract available.'}, {'pmid': '20159812', 'type': 'BACKGROUND', 'citation': 'Gomez 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.'}, {'pmid': '26083835', 'type': 'BACKGROUND', 'citation': 'Lautner 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.'}, {'pmid': '22949130', 'type': 'BACKGROUND', 'citation': 'Freedman 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.'}, {'pmid': '24311961', 'type': 'BACKGROUND', 'citation': 'Cao 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.'}, {'pmid': '25957740', 'type': 'BACKGROUND', 'citation': 'Ye 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.'}, {'pmid': '19801315', 'type': 'BACKGROUND', 'citation': 'Smith 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.'}, {'pmid': '16470610', 'type': 'BACKGROUND', 'citation': 'Chagpar 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.'}, {'pmid': '11304779', 'type': 'BACKGROUND', 'citation': 'Morrow 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.'}, {'pmid': '12216083', 'type': 'BACKGROUND', 'citation': 'Staradub 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.'}, {'pmid': '26133235', 'type': 'BACKGROUND', 'citation': 'Churilla 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.'}, {'pmid': '11182389', 'type': 'BACKGROUND', 'citation': "Nold 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."}, {'pmid': '1551058', 'type': 'BACKGROUND', 'citation': 'Ganz 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.'}, {'pmid': '22293254', 'type': 'BACKGROUND', 'citation': 'Narendra 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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nSurgeon 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.\n\nHence 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.\n\nWe plan to administer the questionnaire to approximately 100 surgeons, equally distributed within aforementioned sectors.", 'detailedDescription': "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.\n\nInterestingly, 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.\n\nAge 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.\n\nAvailability 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.\n\ncountry 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.\n\nTMH 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.\n\nIn 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.\n\nNine 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.\n\nTMH 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.\n\nWe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nWe plan to administer the questionnaire to approximately 100 surgeons.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Surgeon having experience in and working in Breast oncological surgeries\n\nExclusion Criteria:\n\n* Not Any'}, 'identificationModule': {'nctId': 'NCT04799951', 'briefTitle': 'A Survey to Assess Knowledge, Attitudes & Practices in Surgeons With Regards to Breast Conservation Surgery & Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tata Memorial Centre'}, 'officialTitle': 'A Survey to Assess Knowledge, Attitudes and Practices Amongst Surgeons With Regards to Breast Conservation Surgery and Mastectomy', 'orgStudyIdInfo': {'id': '3212'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Surgeon', 'description': 'surgeons having experience in and regularly conducting breast conservation surgery and mastectomy surgeries', 'interventionNames': ['Other: a survey questionnaire to find knowledge, attitude and practices in treatment of breast cancer.']}], 'interventions': [{'name': 'a survey questionnaire to find knowledge, attitude and practices in treatment of breast cancer.', 'type': 'OTHER', 'description': 'an electronic webbased survey to assess knowledge, attitudes and practices amongst surgeons with regards to breast conservation surgery and mastectomy', 'armGroupLabels': ['Breast Surgeon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Tata Memorial Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'overallOfficials': [{'name': 'Nita Nair, MCH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tata Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'As per IEC mandate all data and responses will be kept anonymous hence will not be shared with anyone.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Memorial Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Surgeon Breast oncology services)', 'investigatorFullName': 'Nita Sukumar Nair', 'investigatorAffiliation': 'Tata Memorial Centre'}}}}