Assessment of Quality of Life of Breast Cancer Survivors Post 5 Years from Surgery: Study from a Community Hospital in India

doi:10.21203/rs.3.rs-4194565/v1

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Assessment of Quality of Life of Breast Cancer Survivors Post 5 Years from Surgery: Study from a Community Hospital in India

https://doi.org/10.21203/rs.3.rs-4194565/v1

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Background: Breast cancer is the most common cancer afflicting women with an estimated 2.1 million new cases diagnosed globally every year. Breast cancer and its treatment significantly impair the patient’s physical mental health and thereby affect their overall quality of life (QOL). Our aim was to identify differences in long-term QOL between breast conservative surgery (BCS) and modified radical mastectomy (MRM) for early breast cancer among sociodemographic and clinical subgroups of patients.

Methods: This prospective observational cohort study was conducted at Bhabha Atomic Research Centre (BARC) hospital under Universal Health Coverage scheme. We recruited patients who were surgically treated for breast cancer between 2010 to 2015 and were continuing further treatment or follow-up. Their QOL scores were measured using the 37-item Functional Assessment of Cancer Therapy- Breast, Version 4 (FACT-B) questionnaire andwere analysed using Mann-Whitney U test. P value <0.05 was considered statistically significant.

Results: Among the 86 patients (46 with BCS and 41 with MRM) included in the study, the mean age was 59 ± 11.5 years with a mean follow-up period of 6.9 years. Functional well-being was significantly better for the BCS group (P<0.01). However, the QOL scores corresponding to physical, social, and emotional well-being as well as body image and attractiveness scores for BCS and MRM at the end of the follow-up period were comparable (p>0.05).

Conclusion: Functional well-being was the only component of QOL that was noted to be higher for BCS for our study population. Future work on understanding the behavioural and cognitive components of body image in this patient population is warranted.

Breast cancer

Quality of life

Modified Radical Mastectomy (MRM)

Breast Conservation Surgery (BCS)

Breast cancer is the most common cancer in women with an estimated 2.1 million new cases being added globally each year and represents a quarter of all cancer diagnoses affecting women.[1] India has documented high breast cancer burden with a prevalence of 25.8 and mortality of 12.7, per 100,000 women respectively.[2] Early detection and improved treatment facilities for breast cancer have increased patient survival, resulting in a greater emphasis on survival ship issues and ‘Quality of Life' (QOL) outcomes, globally as well as in India.[3, 4] Surgery remains the mainstay treatment in patients with breast cancer and two surgical options exist - modified radical mastectomy (MRM) and breast conservation surgery (BCS). MRM and BCS with postoperative radiotherapy have shown equivalent survival in many long-term follow-up studies.[5, 6] Since BCS has equivalent survival and is a less extensive and disfiguring procedure, it is often preferred over MRM, especially in high-income countries (HICs). Many long-term studies have documented better QOL in BCS patients from these HICs.[7, 8] Bhat et al have also documented better QOL in BCS group at the end of five years at a tertiary centre in India.[9] Yet many patients in India and other low-and-middle-income countries (LMICs) lack access to radiotherapy (RT) making BCS a less common option.

However, healthcare centres providing universal health coverage offer a unique setting, where BCS and RT can be offered at no extra cost or accessibility barriers. QOL outcomes then may override the affordability and feasibility concerns and become important factors driving the clinical decision-making process for patients with early breast cancer. The QOL issues among breast cancer survivors, within a setting of universal care, is likely to gain more importance in the Indian context as India moves towards universal health care with the Ayushman Bharat (Prime Minister’s) health scheme.[10]

Much of the existing literature on impact of surgery on QOL is set in HICs and the Indian perspective in particular, is limited.[11, 12] Moreover, most have recorded QOL at 5 years after surgery or even shorter duration, maximum studies recording QOL at 1 year post surgery. Patients defaulting follow-ups and incomplete records during follow-ups are main challenges in conducting long-term studies in India.[13, 14] Therefore, we undertook this study to compare the long-term changes in QOL outcomes for BCS and MRM at a community hospital in patients receiving breast cancer treatment under universal health coverage scheme. This enabled a follow up of patients at no added cost in a robust healthcare system.

Study design

This prospective observational study was conducted in 2020 and patients operated between 2010 and 2015 were included. Patients with metastatic disease were excluded.

Context and setting

We conducted this study in the Department of Surgery, Bhabha Atomic Research Centre (BARC) hospital, a multi-specialty government funded community hospital which provides universal health coverage. Under this scheme, treatment is provided equitably and free of cost and the choice of treatment is unaffected by the economic status of patients, thereby making this centre a preferable setting for the study. The details of this community hospital, universal health coverage system and the patient cohort are described in detail in our previous manuscript that describes the trends in QOL scores over first five years after surgery.[15] This manuscript analyses QOL scores beyond the five year period after surgery, during a long-term follow-up.

All patients receiving care under this health plan were encouraged to choose between the two surgical alternatives for treatment (BCS and MRM), after being informed that BCS requires postoperative radiation. Depending on the surgical modality each patient underwent, a standardised protocol for treatment based on guidelines. This uniform treatment protocol, the hospital’s robust electronic medical records system and a breast cancer registry enabled the retrieval of accurate data on demography, clinical notes, investigations, management protocols and details of every follow-up visit.

Data collection

Data was collected using a validated questionnaire during the routine follow-up visits in the out-patient department, after obtaining written, valid informed consent from the study participants. Those who were unable to read and write in English, were interviewed by the trainee doctor in vernacular languages. The data collected contained demographic characteristics including age, sex, education level, menstrual status, family history and marital status at the time of diagnosis as well as their tumour characteristics and the QOL scores.

Study tool

The QOL was measured using the Functional Assessment of Cancer Therapy- Breast, Version 4 (FACT-B) questionnaire, which is validated for Indian women. It is a 37-item scale that assesses a patient's emotional status, functional capability, social well-being, and physical well-being. Additionally, the FACT-B trial outcome index (FACT-B TOI), FACT-B Total Score (FACT-B TS), Breast Cancer Subscale (BSS), and FACT-G (global) score were noted. The Functional Assessment for Chronic Illnesses Therapy (FACIT) measuring system was employed to assess the FACT-B questionnaire responses. (Supplementary Table 1)

Statistical methods

The data was analysed using SPSS version 20.0 (SPSS Inc, Chicago, IL, USA) statistical software. The categorical variables were described as frequency and percentages and chi square test or Fisher’s exact test was used for association analysis. The continuous variables were represented as mean (with standard deviation) and changes in QOL were tested using Mann-Whitney U test. P value of < 0.05 was considered as statistically significant.

140 patients were operated on at BARC hospital between 2010–2015, of which 35 (21 metastatic disease + 14 deaths) were excluded. Of the 105 remaining, 21 were lost to follow-up, 4 had other associated cancers, 2 had poor general condition and 1 refused participation, who were excluded. Thus, 86 patients were included in the final cohort for this questionnaire-based study, of which 45 were operated for BCS and 41 underwent MRM.

Table 1 describes the characteristics of the participants and their association with type of surgery (BCS and MRM). The mean age of patients was 59 ± 11.5 years and the follow-up period ranged between 5 to 10 years with a mean of 6.9 years. Over half (52.9%) of post-menopausal women showed preference for MRM, whereas 70.7% of women with higher education and 58.3% of those who had partners demonstrated preference for BCS. BCS was also the preferred choice of surgery for 85.7% of those with a family history of breast cancer. 70% had Stage 2 disease, however it was not associated with the preference of surgery.

Table 1

Characteristics of cohort and FACT B score comparison between BCS and MRM patients
Demographics and oncology variables		BCT	MRM	Grand Total	P value
	Count	45	41	86
	Age (Mean + SD)	54.2 + 9.6	65.1 + 10.9	59.4 + 11.5	0.000
Menopausal Status, N (%)
	Pre-menopausal	12 (75)	4 (25)	16	0.044
	Post-menopausal	33 (47.1)	37 (52.9)	70
Married Status, N (%)
	Married	42 (58.3)	30 (41.7)	72	0.011
	Widowed	3 (21.4)	11 (78.6)	14
Educational Status, N (%)
	Illiterate	3 (42.9)	4 (57.1)	7	0.004
	Primary/Secondary level	13 (34.2)	25 (65.8)	38
	Educated (Graduation above)	29 (70.7)	12 (29.3)	41
Family History of Breast Cancer, N (%)
	No	33 (45.8)	39 (54.2)	72	0.006
	Yes	12 (85.7)	2 (14.3)	14
Tumour Size*, N (%)
	T1	11 (64.7)	6 (35.3)	17	0.530
	T2	27 (51.9)	25 (48.1)	52
	T3	3 (30)	7 (70)	10
	T4	3 (60)	2 (40)	5
Stage*, N (%)
	1	11 (73.3)	4 (26.7)	15	0.360
	2	28 (47.5)	31 (52.5)	59
	3	5 (55.6)	4 (44.4)	9
	4	0	1	1
Chemotherapy, N (%)
	No	15 (40.5)	22 (59.5)	37	0.057
	Yes	30 (61.2)	19 (38.8)	49
Radiotherapy^#, N (%)
	No	4 (12.5)	28 (87.5)	32	0.000
	Yes	40 (80)	10 (20)	50
Hormonal Therapy^#, N (%)
	No	11 (42.3)	15 (57.7)	26	0.211
	Yes	32 (57.1)	24 (42.9)	56
Survival Status, N (%)		BCT	MRM	NA	Total
Died Survived		5 (35.7)	5 (35.7)	4 (28.6)	14
Died Survived		56 (44.4)	66 (52.4)	4 (3.2)	126
Note: for two patients records were missing, # for four patients’ data were missing. Stage: Records of 2 patients were missing, RT & HT: Records of 4 patients each were missing)*

The QOL scores for both groups in physical well-being (PWB), social well-being (SWB), emotional well-being (EWB) and breast specific domains as well as total scores were comparable at the end of the follow-up period (p > 0.05). However, based on the FACT-B score, the functional well-being (FWB) scores were better for BCS as compared to MRM (Table 2).

Table 2

Comparison of QOL Scores between BCS and MRM groups.
Domain	BCT	MRM	P value
Physical Well Being (PWB)	26.9 (1.5)	26.9 (2.1)	0.755
Social Well Being (SWB)	27.2 (3.1)	26.1 (4.4)	0.202
Emotional Well Being (EWB)	22.2 (2.4)	22.4 (2.2)	0.638
Functional Well Being (FWB)	26.9 (1.6)	24.9 (3.9)	0.002
Breast Cancer Subscale (BSS)	32.8 (1.9)	31.8 (3.8)	0.12
FACT-B Trial Outcome Index (PWB + FWB + BCS score)	86.6 (3.9)	83.4 (8.2)	0.021
FACT-G Total Score (PWB + SWB + EWB + FWB score)	102.9 (6.2)	100.3 (8.9)	0.105
FACT-B Total score (PWB + SWB + EWB + FWB + BCS score)	135.8 (7.0)	132.1 (11.4)	0.072

Note: All scores presented as Mean (Standard Deviation)

Our study revealed that QOL scores in all domains were similar in BCS and MRM groups after long-term follow-up, except in the functional wellbeing (FWB) domain, which was higher for women undergoing BCS. We also documented that women who were younger, had a history of breast cancer in the family, had formal education, were married and were pre-menopausal preferred BCS over MRM.

Functional wellbeing (FWB) is a measure of an individual's capacity to perform tasks of daily work, socialize and enjoy life. It also measures whether the woman is content with her life and accepted her illness.[16] The better functional scores in the BCS subgroup in our study may be attributed to only a minimal disfigurement and disruption of body form after surgery, leaving women free to focus on function and life rather than physical form, shape and image. This explanation can also be extrapolated to the higher scores of FACT B TOI in BCS patients in our study. This outcome index is a sum of functional, physical and breast subscale scores that additionally includes questions regarding arm pain and oedema, body shape and form, comfort in dressing and feeling of being attractive. This combined outcome index reflects the woman's overall confidence and comfort about herself, resulting in better functional outcomes. Bhat et al. reported better acceptance of disease, body image and coping with cancer in BCS groups, during a follow up period of 2.5 years.[9] Similarly, a recent meta-analysis that included 18 studies assessing QOL scores in patients with BCS, reconstruction and mastectomy documented a better global, and component scores in BCS when compared to MRM.[17] Our group previously reported that all QOL scores, including FWB, showed no statistical difference in BCS and MRM groups at 5 years of follow-up.[15] Thus, longer follow-up, such as in the current study, may help unmask persisting insufficiencies of functional ability, acceptance of the disease and disfigurement among MRM patients.[5] This highlights the need for long-term support and coping strategies for breast cancer patients.

In our cohort, we reported significant differences in patients’ preference of surgical options for breast cancer. Younger, premenopausal, educated and patients with partners preferred less disfigurement and morbidity. This is in agreement with other reports of patients-preference being dependent on factors such as age, educational status, and family history.[18, 19]

Since MRM is the most performed surgery for breast cancer in India, this study highlights the need of long-term support to patients undergoing MRM. It also emphasises on offering BCS, whenever feasible oncologically and socioeconomically, to women in India.

Long-term follow-up of our cohort is a unique strength of this study. Most Indian studies have addressed QOL scores during short-term follow-up less than five years.[9, 13, 20] The setting of the universal health care system, allowing equitable and free of cost healthcare delivery, freeing them to choose between BCS and MRM, is a strength of this study. This mimics an ideal situation without socioeconomic barriers.

While the uniqueness of the setting may limit generalisability of the study in India and can be currently viewed as a limitation, increasing implementation of UHC in India, positions this study in a new light. The FACT-B score is a quantitative method of assessing sensitive issues in breast cancer like sexuality, body image, and interpersonal relationships with family and friends. Although it provides a broad idea about breast specific concerns, it does not comprehensively explore the perceptual and cognitive aspects of body image.

In summary, we documented that, on long-term follow-up, functional wellbeing was better in women whose breasts were conserved. To better understand the underlying causes of these results, additional large sample quantitative and other qualitative studies to analyse the cognitive, behavioural, and affective components of QOL are required. These may offer a more granular understanding of QOL in breast cancer patients.

MRM- Modified Radical Mastectomy

BCS- Breast Conservation Surgery

RT- Radiotherapy

QOL- Quality of Life

PWB- Physical well-being

SWB- Social well-being

FWB- Functional well-being

EWB- Emotional well-being

FACT-B- Functional Assessment of Cancer Therapy- Breast

Ethical considerations- The study was approved by the Institutional Ethics Committee of BARC hospital (IEC number BHMEC/DNB/21/18).

Consent for Publication- All authors have consented for the publication of this report.

Availability of data and materials- The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests- The authors do not declare any financial or non-financial competing interests.

Funding- This is a non-funded study.

Authors’ contribution- The authors Vasundhara Mathur, Niranjana Swaminathan, Priyansh Nathani, and Bhakti Sarang have contributed in the writing of the manuscript. The author Prashant Bhandarkar has contributed in the statistical analysis and writing the results in the manuscript. The authors Anita Gadgil and Nobhojit Roy have contributed in the conceptualisation, writing and review of the manuscript.

Acknowledgements- The authors would like to acknowledge WHO collaborating Centre for Research in Surgical Care Delivery, India. Also, due credit to be given to Breast Cancer Consortium, WHOCC, India for the regular meetings and guidance.

Statement Of Declaration- All authors acknowledge that they are not affiliated to or a part of any group or organization that has a financial or non-financial involvement in the subject or materials addressed in this manuscript.

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No competing interests reported.

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Assessment of Quality of Life of Breast Cancer Survivors Post 5 Years from Surgery: Study from a Community Hospital in India

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