NCT04799951

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

May 26, 2020

Last Update Submit

March 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (1)

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.

Interventions

an electronic webbased survey to assess knowledge, attitudes and practices amongst surgeons with regards to breast conservation surgery and mastectomy

Breast Surgeon

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Not Any

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (15)

  • 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: 27066455BACKGROUND
  • NIH consensus conference. Treatment of early-stage breast cancer. JAMA. 1991 Jan 16;265(3):391-5. No abstract available.

    PMID: 1984541BACKGROUND
  • 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: 20159812BACKGROUND
  • 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: 26083835BACKGROUND
  • 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: 22949130BACKGROUND
  • 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: 24311961BACKGROUND
  • 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: 25957740BACKGROUND
  • 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: 19801315BACKGROUND
  • 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: 16470610BACKGROUND
  • 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: 11304779BACKGROUND
  • 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: 12216083BACKGROUND
  • 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: 26133235BACKGROUND
  • 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: 11182389BACKGROUND
  • 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: 1551058BACKGROUND
  • 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.

    PMID: 22293254BACKGROUND

MeSH Terms

Conditions

Behavior

Study Officials

  • Nita Nair, MCH

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Surgeon Breast oncology services)

Study Record Dates

First Submitted

May 26, 2020

First Posted

March 16, 2021

Study Start

April 2, 2019

Primary Completion

September 30, 2019

Study Completion

October 31, 2019

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

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

Locations