BACKGROUND AND INTRODUCTION
Breast conservation therapy has been highlighted as to be efficient as mastectomy in the curing of tumors of about 2 centime1ters or smaller 1 . On the other hand, proof of its efficiency, in patients diagnosed with tumors more than 2 centimeter over the long term is limited 2 . From May 1980 through to May 1986, a randomized and multicenter trial to compare breast conservation therapy was conducted with mechanized radical mastectomy for patients diagnosed with tumors measuring up to 5 centimeters 3 . In analysis, this study will assess whether the treatments will result in different general survival, time to loco-regional or distant metastasis recurrence. Therefore, the purpose of this synopsis will be to compare the quality of life as well as the general satisfaction with therapy of women with early stage of breast cancer cured undergoing breast conservation therapy or mastectomy in oncology Centers in Dakshina Kannada, Karnataka.
The importance of this preliminary synopsis is to establish the end results of quality of life among patients undergoing mastectomy and breast conservation treatment within patients with early breast cancer 4 . The study is relevant in highlighting the possible effects of autologous reconstruction among patients and the patient’s preference as the driving force behind receiving mastectomy 5 . Thus, the study results will be applicable in the analysis of patient’s perception regarding cosmetic outcomes as one of the integrated designs of breast cancer trails in Dakshina Kannada, Karnataka 6 .
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Research Questions
Is breast conservation an alternative or equivalent to mastectomy?
What are the contributing factors for the up surged usage of mastectomy?
What are the driving forces behind patient’s receiving mastectomy or breast conservation?
What are the patient’s perception regarding cosmetic outcome?
Research Objective
To determine whether breast conservation is medicinally alternative to mastectomy
To establish the contributing factors towards patient preference to mastectomy
To find out the driving forces behind patient’s receiving mastectomy or breast conservation
To evaluate the patient’s perception regarding cosmetic outcome.
Literature Review
Random attempts have showed that breast conservation is a substitute replacement to mastectomy for majority of patients diagnosed with early-stage breast cancer 7 . Nonetheless, a significant patients’ minority are receiving mastectomy 8 . The decision is mostly driven by the preference of the patient whereas in others it is driven by breast conservation’s contraindications 9 . Some research show that in Dakshina Kannada, Karnataka, amounts of both unilateral as well as bilateral mastectomy are on the rise. The reason for high-level usage of mastectomy is indefinite; however it seems to be as a result of the patient’s decision 10 . Moreover, some patients have proposed that enhanced cosmetic result with contemporary mechanisms of reconstruction of breast might give rise to this tendency 11 . The long lasting life quality coupled with cosmetic results after varied approaches can therefore be a significant regard for patients while choosing a local treatment alternative for cancer of the breast therapy 12 .
The perception of the patient on cosmetic results is a vital endpoint 13 . Cosmetic result measures that are self-supported are presently highly integrated into design of breast cancer clinical attempts 14 . Even though there is an increasing growth in the recent years to date, on the interest in patient-reported results, this research lacks data regarding on the satisfaction on patient-reports with cosmetics results of breast cancer therapy after an early post-operative duration. This is specifically among the survivors of breast cancer who got their in different contexts and with different treatment approaches.
Thus, in a section of survivors of breast cancer established via two registries based on metropolitan population, quality of life and long term satisfaction of patient-reports were described with cosmetic results after therapeutic breast cancer 15 . Particularly, a comparison was made on outcomes among patients undergoing mastectomy only and patients receiving therapy on breast conservation 16 . A further consideration was made in the subset obtaining reconstruction, whether; reconstruction timing, type or characteristics of the patient were related with satisfaction of cosmetic 17 . Due to the possible consequences for clinical practice 18 , there was a specific interest in assessing the assumption that the effect of reconstruction timing and type on patient results may vary among patients who receive radiotherapy after mastectomy, as compared to patients who do not.
Research Hypothesis
Breast conservation is an alternative or substitute replacement to mastectomy for majority of patients diagnosed with early-stage breast cancer.
The contributing factors for the up surged usage of mastectomy are the patient’s decision and enhanced cosmetic result with contemporary mechanisms of reconstruction of breast.
The driving forces behind patient’s receiving mastectomy or breast conservation are preference of the patient and breast conservation’s contraindications.
The patient’s perception regarding cosmetic outcome are presently and highly integrated into design of breast cancer clinical trials.
MATERIAL AND METHODS
Study Design
The study design will be based on survey method where data will be collected from the members of the sampled population for the purposes of estimating the population parameters. Breast cancer patients will be interviewed before undergoing mastectomy and afterwards through the use of European Organization for Research and Treatment of Cancer Core Questionnaire (and QLQ-Br23). 19 Socio economic dimensions such as occupation, educational level, body mass index and family income will be considered as investigating aspects 20 . These factors will be measured against breast cancer- and health related factors.
Setting
The study will be carried out in oncology centers in Dakshina Kannada, Karnataka
Duration of Study
After physicians’ notification, the study duration will be expected to take an average of 36 weeks after diagnosis on 3133 patients, an average of 36 weeks after diagnosis. Thus, the average period from breast cancer identification to investigation return will be 288 days. The respondents will be contacted after an estimated four years to finish a follow-up investigation. Thus, the average period to survey response after diagnosis will be 1524 days.
Sample Size
The total patient population that will be under investigation is expected to be approximately 3133. Out of the patients population that will be expected to responded to the investigations, as well as who will undergo no relapse, is anticipated to be about 963 patients undergoing breast conservation surgery, and 263 patients undergoing mastectomy with no reconstruction whereas 222 patients undergoing mastectomy with reconstruction. Satisfaction due to cosmetic will be determined between patients obtaining mastectomy coupled with reconstruction and patients obtaining breast conservation therapy. In patients that will be attended to with mastectomy with reconstruction, the linkage between radiation receipt and reconstruction type will be established with regards to satisfaction and scores recorded 21 . However, the study will adjust scale satisfaction mark of about 5.0 for patients so as to obtain autologous restoration in absence of radiation, 4.5 for patients obtaining both autologous reconstruction as well as radiation treatment, 4.0 for patients obtaining implant reconstruction in absence of radiation therapy and lastly, 2.8 for patients obtaining both implant radiation and reconstruction treatment 22 .
Sampling Technique
The sampling technique will be based on probability sampling particularly purposive random sampling. Here, each participant drawn from the target population will have an equal chance of inclusion in the sample.
Sample Selection
The study will be based on a longitudinal and multicenter women cohort diagnosed with cancer of the breast in Dakshina Kannada, Karnataka. The source of data will be established on the reports of the Institute of National Cancer Surveillance, Epidemiology and End Results (SEER). These will be the registries of the population based program within the regions who will qualify for sample selection.
Data Collection Procedure
After endorsement by IRB, qualified patients will be determined through rapid case determination. After physicians’ notification, the research will be based on 3133 patients, an average of 36 weeks after diagnosis. Thus, the average period from breast cancer identification to investigation return will be 288 days, and standard deviation will be 1000. The respondents will be contacted after an estimated four years to finish a follow-up investigation. Thus, the average period to survey response after diagnosis will be 1524 days and standard deviation will be 143. There will as well be the application of Dillman method, which will include reminding non responders and so as to attain 73 percent and 68 percent proportions of response. All research resources will be documented in English. Baseline as well as follow-up surveys for responses will be merged to one dataset, and which clinical information from SEER will be included. Questionnaires will be generated after a consideration of pre-existing literature, formerly established measures which will assist in examining applicable constructs as well as theoretical approaches. The research will apply standard models of content authentication, such as methodical review by design specialists and intellectual pre-testing with patients 23 .
Data Analysis
Data analysis will be conducted through the use of mean scores, percentages, simple variance analysis and standard deviation to compare the socio-economic problems and quality of life between breast conserving treatment and mastectomy among early breast cancer patients attending oncology centers in Dakshina Kannada, Karnataka.
SUMMARY AND CONLUSION
The outcomes of the existing research offer an inspiring proof that quality of life as well as satisfaction and contentment with cosmetic results within survivors of breast cancer is high generally. The outcomes propose that breast reconstruction provide patients experiencing mastectomy to achieve satisfaction that is long lasting the same as that of patients experiencing conservation of breast. The outcomes on the hazardous effect of radiation about satisfaction after reconstruction of breast might have consequences for the choice of patient. The possible effect of autologous restoration in controlling the impact qualifies supplementary evidence in autonomous and multicenter datasets. The decision of the patient regarding whether to have reconstruction and the particular type as well as reconstruction time, should be conceptually conversant with rigorous, multicenter results information such as the data offered in this research.
References
Agarwal, S., Kidwell, K. M., Farberg, A., Kozlow, J. H., Chung, K. C., & Momoh, A. O. (2015). Immediate reconstruction of the radiated breast: recent trends contrary to traditional standards. Annals of surgical oncology , 22 (8), 2551-2559.
Baumann, D. P. (2013). Effects of Radiation Therapy for Breast Cancer Based on Type of Free Flap Reconstruction. Breast Diseases: a YB Quarterly , 24 (2), 194-196.
Benjamin, D. et al. (2014). Sample records for patients undergoing mastectomy. Science.gov . retrieved from http://www.science.gov/topicpages/p/patients+undergoing+mastectomy.html.
Cano, S. J., Klassen, A. F., Scott, A. M., & Pusic, A. L. (2013). A closer look at the BREAST-Q©. Clinics in plastic surgery , 40 (2), 287-296.
Cordeiro, P. G. (2012). Discussion: current status of implant-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plastic and reconstructive surgery , 130 (4), 524e-525e.
Fancellu, A. (2016). Considerations arising from requests from patients for a bilateral mastectomy who are eligible for breast‑conserving surgery: Factors weighing for and against performing the operation. Oncology Letters , 12 (1), 764-766.
Ho, A., Cordeiro, P., Disa, J., Mehrara, B., Wright, J., Van Zee, K. J., ... & Powell, S. (2012). Long‐term outcomes in breast cancer patients undergoing immediate 2‐stage expander/implant reconstruction and postmastectomy radiation. Cancer , 118 (9), 2552-2559.
Jagsi, R., Li, Y., Morrow, M., Janz, N., Alderman, A., Graff, J., ... & Hawley, S. (2015). Patient-reported quality of life and satisfaction with cosmetic outcomes after breast conservation and mastectomy with and without reconstruction: results of a survey of breast cancer survivors. Annals of surgery, 261 (6), 1198-1206.
Kronowitz, S. J. (2012). Current status of implant-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plastic and reconstructive surgery , 130 (4), 513e.
Mansour, M. A; Sonbaty, M. E. (2016). Enhancing needle visualization during parasagittal approach in paravertebral block for patients undergoing simple mastectomy using in-plane, multiangle ultrasound needle guidance system. Saudi J Anaesth. 10 (1): 33–37.
Miriam A. G. et al. (2016). The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life Questionnaire Module: First Results from a Three-Country Field Study. Journal of Clinical Oncology, 14 (10), 2756-2768.
Olivotto, I. A., Whelan, T. J., Parpia, S., Kim, D. H., Berrang, T., Truong, P. T., ... & Germain, I. (2013). Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. Journal of Clinical Oncology , 31 (32), 4038-4045.
Portschy, P. R., & Tuttle, T. M. (2013). Rise of mastectomy. Journal of surgical oncology, 107(6), 563-564.
Portschy, P. R., & Tuttle, T. M. (2013). Rise of mastectomy. Journal of surgical oncology , 107 (6), 563-564.
Sabel, M. S., Kraft, C. T., Griffith, K. A., Bensenhaver, J. M., Newman, L. A., Hawley, S. T., & Momoh, A. O. (2016). Differences between Breast Conservation‐Eligible Patients and Unilateral Mastectomy Patients in Choosing Contralateral Prophylactic Mastectomies. The Breast Journal , 22 (6), 607-615.
Zhong, T., Fernandes, K. A., Saskin, R., Sutradhar, R., Platt, J., Beber, B. A., ... & Baxter, N. N. (2014). Barriers to immediate breast reconstruction in the Canadian universal health care system. Journal of Clinical Oncology , JCO-2013.
Appendix 1: Questionnaire
The following questions are intended to assess patient satisfaction regarding breast cancer surgery
|
Questions |
Answers |
||||||
| 1. How would you assess the aesthetic outcomes of your surgery due to breast cancer? | 1 dreadful | 2 | 3 | 4 | 5 | 6 | 7 excellent |
| not at all | slightly | moderately | very much so | ||||
| 2. In your view, did surgery due to breast cancer result in a significant change to your physical appearance? | 1 | 2 | 3 | 4 | |||
| 3. Has your physical appearance triggered you any emotional stress in your relations with your family, close friends or partner? | 1 | 2 | 3 | 4 | |||
| 4. Is your day to day life still compromised as a result of the surgery due to breast cancer? | 1 | 2 | 3 | 4 | |||
| 5. Do you regret having chosen breast cancer surgery (BCT or MRM+IBR)? | 1 | 2 | 3 | 4 | |||
| 6. Do you have fear of a return of breast cancer? | 1 | 2 | 3 | 4 | |||
| 7. In reflection, would you choose a different surgical therapy of breast cancer? | Yes | - | - | No | |||
1 Cano, S. J., Klassen, A. F., Scott, A. M., & Pusic, A. L. (2013). A closer look at the BREAST-Q©. Clinics in plastic surgery , 40 (2), 287-296.
2 Portschy, P. R., & Tuttle, T. M. (2013). Rise of mastectomy. Journal of surgical oncology , 107 (6), 563-564.
3 Cordeiro, P. G. (2012). Discussion: current status of implant-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plastic and reconstructive surgery , 130 (4), 524e-525e.
4 Sabel, M. S., Kraft, C. T., Griffith, K. A., Bensenhaver, J. M., Newman, L. A., Hawley, S. T., & Momoh, A. O. (2016). Differences between Breast Conservation‐Eligible Patients and Unilateral Mastectomy Patients in Choosing Contralateral Prophylactic Mastectomies. The Breast Journal , 22 (6), 607-615.
5 Zhong, T., Fernandes, K. A., Saskin, R., Sutradhar, R., Platt, J., Beber, B. A., ... & Baxter, N. N. (2014). Barriers to immediate breast reconstruction in the Canadian universal health care system. Journal of Clinical Oncology , JCO-2013.
6 Agarwal, S., Kidwell, K. M., Farberg, A., Kozlow, J. H., Chung, K. C., & Momoh, A. O. (2015). Immediate reconstruction of the radiated breast: recent trends contrary to traditional standards. Annals of surgical oncology , 22 (8), 2551-2559.
7 Portschy, P. R., & Tuttle, T. M. (2013). Rise of mastectomy. Journal of surgical oncology , 107 (6), 563-564.
8 Benjamin, D. et al. (2014). Sample records for patients undergoing mastectomy. Science.gov. retrieved from http://www.science.gov/topicpages/p/patients+undergoing+mastectomy.html.
9 Jagsi, R., Li, Y., Morrow, M., Janz, N., Alderman, A., Graff, J., ... & Hawley, S. (2015). Patient-reported quality of life and satisfaction with cosmetic outcomes after breast conservation and mastectomy with and without reconstruction: results of a survey of breast cancer survivors. Annals of surgery , 261 (6), 1198-1206.
10 Fancellu, A. (2016). Considerations arising from requests from patients for a bilateral mastectomy who are eligible for breast‑conserving surgery: Factors weighing for and against performing the operation. Oncology Letters , 12 (1), 764-766.
11 Olivotto, I. A., Whelan, T. J., Parpia, S., Kim, D. H., Berrang, T., Truong, P. T., ... & Germain, I. (2013). Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. Journal of Clinical Oncology , 31 (32), 4038-4045.
12 Cano, S. J., Klassen, A. F., Scott, A. M., & Pusic, A. L. (2013). A closer look at the BREAST-Q©. Clinics in plastic surgery , 40 (2), 287-296.
13 Kronowitz, S. J. (2012). Current status of implant-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plastic and reconstructive surgery , 130 (4), 513e.
14 Cordeiro, P. G. (2012). Discussion: current status of implant-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plastic and reconstructive surgery , 130 (4), 524e-525e.
15 Kronowitz, S. J. (2012). Current status of autologous tissue-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plastic and reconstructive surgery , 130 (2), 282.
16 Ho, A., Cordeiro, P., Disa, J., Mehrara, B., Wright, J., Van Zee, K. J., ... & Powell, S. (2012). Long‐term outcomes in breast cancer patients undergoing immediate 2‐stage expander/implant reconstruction and postmastectomy radiation. Cancer , 118 (9), 2552-2559.
17 Mansour, M. A; Sonbaty, M. E. (2016). Enhancing needle visualization during parasagittal approach in paravertebral block for patients undergoing simple mastectomy using in-plane, multiangle ultrasound needle guidance system. Saudi J Anaesth. 10( 1): 33–37
18 Baumann, D. P. (2013). Effects of Radiation Therapy for Breast Cancer Based on Type of Free Flap Reconstruction. Breast Diseases: a YB Quarterly , 24 (2), 194-196.
19 Miriam A. G. et al. (2016). The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life Questionnaire Module: First Results from a Three-Country Field Study. Journal of Clinical Oncology, 14( 10), 2756-2768.
20 Fancellu, A. (2016). Considerations arising from requests from patients for a bilateral mastectomy who are eligible for breast‑conserving surgery: Factors weighing for and against performing the operation. Oncology Letters , 12 (1), 764-766.
21 Baumann, D. P. (2013). Effects of Radiation Therapy for Breast Cancer Based on Type of Free Flap Reconstruction. Breast Diseases: a YB Quarterly , 24 (2), 194-196.
22 Benjamin, D. et al. (2014). Sample records for patients undergoing mastectomy. Science.gov . retrieved from http://www.science.gov/topicpages/p/patients+undergoing+mastectomy.html.
23 Kronowitz, S. J. (2012). Current status of implant-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plastic and reconstructive surgery , 130 (4), 513e.
