Low Quality of life (QoL) in Indian breast cancer patients: a critical analysis of UP

doi:10.21203/rs.3.rs-80999/v2

Background

Breast cancer is the most frequent cancer among women worldwide, and India is no exception to this devastating disease. Cancer can cause a variety of symptoms, some of which are complex and others which are not. Quality of Life is a word that encompasses physical, psychological, spiritual, and social components of quality of life.

Objective

The objective of this study is to evaluate quality of life in breast cancer patients who are getting treatment with various modalities at various stages of the disease.

Methods

A total of 150 breast cancer patients were included in this cross-sectional investigation. Ferrel's Quality of Life Instrument-Breast Cancer Patient Version was used to assess patients' quality of life, and the instrument has already been validated by Ferrel BR et al (2012). General well-being, psychological well-being, distress, fearfulness, social concerns, and spiritual well-being are all included in these questions.

Results

There was a link discovered between the type of cancer, the quantity of discomfort, and exhaustion (tiredness). However, no demographic factors (age, married status, or income) were shown to be significantly associated to QoL. Education and treatment type were found to be linked to QoL.

Conclusion

In breast cancer patients, influencing quality of life (QoL) is a major concern. Apart from the effect of treatment, there are additional elements such as socioeconomic position, psychological well-being, fear of recurrence, and so on, which all play a role in a patient's well-being and can be improved if counselled at many levels such as family, hospital, and society.

Breast cancer

chemotherapy

Quality of life

psychological well-being

counseling

Cancer is the second biggest cause of death worldwide, with breast, cervix, ovary, mouth and esophagus, colorectal, and other cancers being the most common in Indian women. Worldwide breast cancer is the commonest cancer (World Health Organization, 2012). Breast cancer, a malignant tumor that starts in the cells of the breast. Both in men and women it occurs. This is an uncommon cancer in men, but it is the second most prevalent cancer in women in India, accounting for roughly 7% of the global burden of breast cancer. Breast cancer accounts for one-fifth of all cancers in women in India, making the issue extremely concerning. In India, 1,62,468 new cases of breast cancer were recorded in 2018, with 87,090 fatalities. Given the continuous importance of the breast cancer problem in terms of rate, morbidity, and mortality, more research is needed to assess and prevent this illness.

Lifestyle changes, older age at consummation, delayed pregnancy, sedentary physical activity and hormonal disorders are contributory factors for promotion of breast cancer in India, other factors like socio-economic status, education level be considered, especially in countries like India where a large percentage of women are from rural backgrounds with limited literacy and healthcare access [1]. There are a variety of treatment options available, with chemotherapy being the most popular, with surgical, radiotherapeutic, and hormonal interventions playing an adjuvant role. Despite the fact that the likelihood of survival among breast cancer patients has increased in recent years as a result of significant breakthroughs in therapy and mammography screening [2], survivors face a variety of medical, physical, and psychosocial challenges [3].

Following a diagnosis, long-term treatment reveals good and negative consequences on recovery and quality of life, as different treatments have varying outcomes. QoL refers to a general sense of well-being, enjoyment, and contentment in life. Overall satisfaction [4], health-related quality of life (HRQoL) appears to cover characteristics of overall QoL that have been shown to affect both physical and mental health. As argued by [5] under the contextual model of HRQoL, diverse variables like care-giving and medical care settings need to be taken into consideration [6] in order to shed more light on the topic.

The current study was planned to evaluate the QOL of women with breast cancer who were under treatment and follow-up at the King George's Medical University, Lucknow, UP, India, because the QoL is an important yet unaddressed aspect of breast cancer that is often overlooked when formulating management strategies.

Data collection

This cross-sectional study was conducted at King George’s Medical University, Lucknow, UP, India between April 2018 and June, 2018. Data was collected using a two-part questionnaire. The first part collected information related to demography, disease and treatment details. The second was a validated scale for assessing breast cancer patients' quality of life.

Sample size

The study population consisted of 150 breast cancer patients from King George's Medical University's Departments of Endocrine Surgery and Radiotherapy in Lucknow. The sample size was assessed using a non-probability exploratory study at 60% prevalence, 95% confidence and taking an error allowance of 10%, resulting in a calculated sample size of 92. After adding for contingency and rounding off, the sample size was kept at 100.

Sampling technique

This is a descriptive study done at King George’s Medical University, UP, Lucknow. Lucknow is the capital of Uttar Pradesh, the largest state in India in terms of population. Because the Institute is a tertiary care center that treats all types of cancer patients, non-probability purposive and convenience sampling was used.

Inclusion and exclusion criteria

All newly diagnosed breast cancer patients over the age of 60 getting treatment at the Outdoor and Indoor Departments of Endocrine Surgery and Radiotherapy were invited to participate in the study, and those who agreed were enrolled. The Institutional Ethics Committee also gave its approval for the study to be conducted.

QoL instrument

The quality of life of patients was measured using a validated QoL questionnaire by Ferrel‘s Quality of Life Instrument-Breast Cancer patient version. The quality-of-life instrument (BREAST CANCER PATIENT VERSION) has forty-six items on ordinal scale (0–10), with higher score indicating a better QoL. This questionnaire covers QoL domains like general well-being, psychological well-being, distress, fearfulness, social concerns and spiritual well-being. Because different domains had varying numbers of items, absolute scores of a domain were converted into weighted scores by dividing them by the number of items, resulting in a maximum potential score of 10 for each domain and the overall weighted sum of 7 dimensions was 70.

Reliability and validity of data

The reliability of the scale was assessed using the Cronbach alpha value computation for the data set obtained in this study which was found to be 0.642, thus showing a moderate reliability of the scale.

Statistical Analysis

SPSS 25.0 was used to analyse the data. Frequencies and percentages, as well as mean and standard deviation, have been used to represent the data. Chi-square test, independent samples ‘t’-test and ANOVA were used to compare the data.

Demographic characteristics of patients

In this study 10.7% respondents were above 60 years of age and 54.7% were between 41and 60. 37.4% were aged less than 40 years. Regarding marital status, married women were 96.7% and 2.7% were unmarried. Among all these women 47.3% were illiterate and 14% were merely educated up to primary level. As far as occupation is concerned, 95.3% were housewives and 3.3% were employed as government servants. 74% of women belong to the low-income category while 25.3% belong to the middle income group. (Table-1)

Clinical and treatment associated characteristics of patients

Staging of all breast cancer patients were I,II,III and IV. 3 patients were of stage I, 26 of stage II, 17 were of stage III while 95 were of stage IV i.e. maximum. Regarding treatment type 90.7% received neo-adjuvant chemotherapy (NACT) while 6% patients received adjuvant chemotherapy (Table-2).

QOL subscale domain scores in relation to demographic and clinical characteristics of the patients

Patients < 40 years of age had the highest scores and patients between 41–60 years had the lowest scores).Urban population had higher scores as compared to rural population. Obese (≥ 30 Kg/m2) had higher scores followed by normal weight (18.4–24.9 Kg/m2). Post-graduates had higher scores followed by higher secondary. Marital status also influences QoL and widows were found to score high. This is seen through Table 3A, Table 3B, Table 3C and Table 3D.

Unemployed had highest scores followed by home maker and for socio-economic status, upper had higher scores followed by middle. Patients with stage-I had highest scores followed by stage-II and surgery has shown highest level of improvement as this treatment type reflects highest scores followed by adjuvant chemotherapy Clinical stage showed significant correlation with social well-being and spiritual well-being.

Correlation between QoL subscale domain scores & demographic and clinical characteristics of the patients

No correlation was found between Total QoL with age, area, weight, marital status, occupation, socio economic status but significant correlation was found between Total QoL with Education. No correlation was found between General QoL with age, area, weight, marital status, occupation. A significant correlation was found between General QoL with Education. No correlation was found between Psychological QoL with all demographic factors. No correlation was found between Distress QoL with age, area, weight, education, marital status and occupation. A significant correlation was found between Distress QoL with socio-economic status. No correlation was found between Fearfulness QoL with all demographic factors. No correlation was found between Self QoL with age, area, weight, marital status, occupation, socio economic status with. A significant correlation was found between Self QoL with Education. No correlation was found between Spiritual QoL with age, area, weight, and occupation. A significant correlation was found between Spiritual QoL with Education, Marital status, and Socio-economic status.

QoL item score analysis

The Table-4 gives the in-depth analysis of various dimensions used in the Ferell instrument.

Physical well-being subscale-highest mean score was observed for menstrual changes or fertility (Mean = 5.41, SD = 2.35) followed by vaginal dryness/ menopausal symptoms (Mean = 5.37, SD = 2.32), Weight gain (Mean = 5.28, SD = 2.36). Psychological well-being subscale- highest score was observed for fear of metastasis (Mean = 6.03, SD = 2.58) followed by appearance (Mean = 6.01, SD = 1.53), treatment completion distress (Mean = 5.39, SD = 1.99). Social well-being subscale-highest score was observed for employment (Mean = 6.73, SD = 2.55) followed by sexuality (Mean = 5.73, SD = 2.27) and support / others (Mean = 5.66,SD = 1.47). The highest score in all was observed in spiritual well-being subscale-spiritual activities (Mean = 6.19, SD = 2.65) followed by religious activities (Mean = 5.95, SD = 2.54) and spiritual changes (Mean = 5.89, SD = 2.34).

The present study used “Ferrel‘s Quality of Life Instrument-Breast Cancer patient version” for evaluating quality of life. This scale collects information related to general, psychological, distress, fearfulness, effect on activity and spirituality domains.

It was discovered that the overall QoL was only 47.8% which is very low and alarming. The major reasons are that in tertiary care hospitals, the treatment is usually provided for inpatients and referral patients from all parts of UP [7]. Breast cancer and breast cancer treatment affect women's QoL in many areas like physical and psychological domains [8]. Breast cancer is linked to a lower quality of life and a reduction in functional capacity in women [9]. Patients with breast cancer viewed treatment to be beneficial in the long run, but they reported numerous issues such as pain, body image, arm symptoms, and so on, and their overall quality of life and functional scores did not improve even after an 18-month follow-up of their therapies [10]. Patients receiving chemotherapy HRQoL were negatively affected [11]. A study [12] showed that most of the Breast cancer patients had poor QoL although married patients had reasonably better QOL than unmarried. A strong correlation was found among QoL and number of treatment cycles, a need to comprehend the basic variables in the patients QoL [12].

Clinical and socio-demographic characteristics were found to have a strong link with breast cancer patients' quality of life. Psychological and financial assistance may improve QoL [13]. Financial assistance and social support may significantly improve the QoL of breast cancer patients [14]. More research is needed to gain a better knowledge of quality-of-life difficulties in breast cancer patients [15]. Many factors influence the quality of life of breast cancer patients; it is necessary to consider all of the patients' feedback on the various challenges they confront, and further study in the area of breast cancer patient QOL is required [16].

In case of Cancer patients, generally this disease is reported at an advanced stage and hence treatment becomes complicated. Considering the population pressure these centers cannot cater all the referred patients on one hand and those catered are mainly rendered mere treatment with no psychological counseling. Psychological, socio-economical, spiritual, cognitional and social dimensions due to various constraints are not given due importance as the patients are from lower- or middle-income status, financial burden of the disease is very high and hence social and constraint plays a pivotal role.

The study's findings indicate that there is no correlation between all QoL domains with age, area (rural/urban), weight / BMI category, marital status and occupation, however, a significant correlation between QoL domains like General QoL, Self QoL and spiritual QoL and education was found. A significant correlation between QoL domains like General, Distress, Effect on activity and spiritual QoL with socio-economic status was also found. A significant correlation was found between spirituality and marital status.

Patients diagnosed with breast cancer and having treatment and follow-up at various departments, such as the Endocrine Surgery department at King George's Medical University in Lucknow, Uttar Pradesh, India, had their QoL assessed. This study illustrates the strength of the link between clinical and socio-demographic characteristics and breast cancer patients' quality of life. The strength of the association between education and physical well-being, social well-being, and spiritual well-being is demonstrated in this study. The study discovered a strong relationship between marital status and spiritual well-being. There was a strong link discovered between clinical stage and spiritual well-being. There was a positive correlation between tumour stage and social and spiritual well-being. There was also a robust link between therapy type and physical, psychological, and social well-being. This study fills a void in the literature regarding QoL in Indian women with breast cancer.

Conflict of interest: There is no conflict of interest.

Source of Funding: NO

Ethical clearance: YES

Acknowledgement: Apart from author and co-authors, there are many people who appendage this work and provided their feedback and support. Especially I would like to thank my Director, Prof. Rohit Kushwaha for providing his valuable inputs and continuous support. I would like to extend my gratitude to Amity Business School, Amity University Uttar Pradesh for its support.

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Table 1: Demographic and General Profile of Patients

SN	Characteristic	No.	Percentage
1.	Age
	<=40 Years	52	34.7
	41-60 Years	82	54.7
	>60 Years	16	10.7
	Mean age±SD (Range) in years	46.55±11.10 (22-75)
2.	Area
	Rural	115	76.7
	Urban	35	25.3
3.	Weight/BMI Category
	Underweight (<18.5 kg/m²)	5	3.3
	Normal weight (18.4-24.9 kg/m²)	90	60.0
	Overweight (25.0-29.9 kg/m²)	47	31.3
	Obese (≥30 kg/m²)	8	5.3
4.	Education
	Illiterate	71	47.3
	Primary	21	14.0
	Upper Primary	13	8.7
	High School	25	16.7
	Higher secondary	3	2.0
	Graduate	14	9.3
	Postgraduate	3	2.0
5.	Marital Status
	Unmarried	4	2.7
	Married	145	96.7
	Widow	1	0.7
6.	Occupation
	Govt. service	5	3.3
	Homemaker	143	95.3
	Unemployed	1	0.7
	Labourer	1	0.7
7.	Socioeconomic status
	Low	111	74.0
	Middle	38	25.3
	Upper	1	0.7

Table 2: Clinical Profile of Patients (TNM Staging)

SN	Characteristic	No.	Percentage
1.	Tumor Stage (n=141)
	1	3	2.1
	2	26	18.4
	3	17	12.1
	4	95	67.4
2.	Nodal involvement	142	94.7
3.	Metastasis (n=145)	26	17.9
4.	Treatment Type
	Adjuvant chemotherapy	9	6.0
	Neoadjuvant chemotherapy	136	90.7
	Surgery	4	2.7
	Targeted therapy	1	0.7

Table 3A : QOL subscale domain scores in relation to demographic characteristics of the patients

		Physical well-being						Psychological well-being
		Mean		SD		p-value		Mean		SD		p-value
Age (years)	<= 40 years		4.45		1.56		.331		5.01		.450		.215
	41-60 years		4.05		1.46				4.87		.719
	>60 years		4.27		1.95				5.12		.490
Geographical area	Urban		4.30		1.55		.181		4.96		.626		.614
	Rural		3.90		1.52				4.90		.602
Weight/ BMI Category	Underweight (< 18.5 Kg/m2)		4.05		1.34		.809		4.69		.684		.438
	Normal weight (18.4-24.9 Kg/m2)		4.23		1.65				4.92		.621
	Over weight (25.0-29.9 Kg/m2)		4.11		1.48				4.96		.624
	Obese (≥30 Kg/m2)		4.68		.933				5.23		.516
Education level	Illiterate		3.95		1.38		.011		4.91		.672		.786
	Primary		4.45		1.55				4.95		.642
	Upper Primary		5.21		1.47				5.13		.540
	High School		3.66		1.72				4.87		.522
	Higher Secondary		5.37		.695				4.81		.363
	Graduation		4.71		1.70				5.04		.575
	Post Graduation		5.50		1.06				5.28		.824
Marital status	Unmarried		5.65		1.89		.085		4.80		.438		.839
	Married		4.16		1.53				4.95		.625
	Widow		6.00						5.18
Occupation	Govt Servant		4.10		.872		.236		5.40		.661		.239
	Homemaker		4.20		1.56				4.93		.615
	Unemployed		7.37						4.95
	Manual Laborer		3.75						4.18
Socio economic status	Low		4.03		1.52		.051		4.88		.654		.133
	Middle		4.73		1.55				5.11		.477
	Upper		4.75						5.18

Table 3B : QOL subscale domain scores in relation to clinical characteristics of the patients

		Physical well-being			Psychological well-being
		Mean	SD	p-value	Mean		SD	p-value
Clinical Stage	IIA	3.45	1.58	.053	4.90		.867	.543
	IIB	5.13	1.93		5.20	.897
	IIIA	4.92	1.70		5.02		.465
	IIIB	3.71	1.15		4.94		.460
	IIIC	3.99	1.56		4.89		.659
	IV	4.62	.		4.00		.
	Unknown	4.50	1.23		5.01		.527
Histo-pathological Grade	I	3.99	1.72	.651	4.84		.661	.732
	II	4.28	1.57		4.96		.636
	III	4.04	1.37		4.97		.507
	Unknown
Tumor stage	1	6.37	1.02	.046	5.68		1.06	.257
	2	4.60	1.70		4.96		.542
	3	3.83	1.13		4.92		.422
	4	4.07	1.51		4.90		.641
	Unknown	4.55	1.79		5.12		.704
Treatment type	Adjuvant Chemotherapy	3.72	1.64	.023	4.66		.428	.004
	Neoadjuvant Chemotherapy	4.21	1.51		4.94		.609
	Surgery	6.03	1.41		5.93		.423
	Targetted therapy	1.50			4.36		.

Table 3C : QOL subscale domain scores in relation to demographic characteristics of the patients

		Social well-being			Spiritual well-being
		Mean	SD	p-value	Mean	SD	p-value
Age (years)	<= 40 years	2.93	.897	.054	5.04	1.70	.240
	41-60 years	2.58	.856		5.51	1.48
	>60 years	2.52	.900		5.25	1.64
Geographical area	Urban	2.73	.886	.332	5.23	1.56	.218
Geographical area	Rural	2.57	.888	.332	5.61	1.61	.218
Weight/ BMI Category	Underweight (< 18.5 Kg/m2)	2.48	.696	.121	5.00	1.25	.370
	Normal weight (18.4-24.9 Kg/m2)	2.62	.900		5.50	1.62
	Over weight (25.0-29.9 Kg/m2)	2.73	.845		5.10	1.50
	Obese (≥30 Kg/m2)	3.38	.900		4.80	1.74
Education level	Illiterate	2.59	.865	.003	5.42	1.51	.000
	Primary	2.94	.611		4.42	.960
	Upper Primary	3.28	.998		4.49	2.11
	High School	2.25	.663		6.58	1.11
	Higher Secondary	3.59	1.33		4.09	.436
	Graduation	2.80	1.07		5.16	1.63
	Post Graduation	3.29	.780		4.19	.704
Marital status	Unmarried	3.00	.696	.373	6.96	1.12	.024
	Married	2.68	.890		5.29	1.56
	Widow	3.77			2.57
Occupation	Govt Servant	2.35	.829	.737	5.05	1.40	.443
	Homemaker	2.71	.893		5.31	1.59
	Unemployed	3.11			7.85
	Manual Laborer	2.22			5.28
Socio economic status	Low	2.60	.872	.064	5.57	1.50	.005
	Middle	2.98	.888		4.62	1.62
	Upper	2.22			4.57

Table 3D : QOL subscale domain scores in relation to clinical characteristics of the patients

		Social well-being			Spiritual well-being
		Mean	SD	p-value	Mean	SD	p-value
Clinical Stage	IIA	2.96	1.84	.183	5.28	1.50	.002
	IIB	3.04	1.12		4.90	1.72
	IIIA	2.95	.805		4.24	1.63
	IIIB	2.64	.939		5.30	1.69
	IIIC	2.51	.814		5.81	1.43
	IV	3.00			4.71	.
	Unknown	2.97	.838		4.71	1.36
Histo-pathological grade	I	2.88	1.01	.491	5.11	1.43	.372
	II	2.64	.904		5.43	1.63
	III	2.79	.678		4.96	1.44
Tumor stage	1	4.48	.390	.002	3.23	.951	.002
	2	2.80	.868		4.69	1.73
	3	2.59	.782		5.27	1.69
	4	2.58	.836		5.65	1.45
	Tx	3.17	1.07		4.44	1.23
Treatment type	Adjuvant Chemotherapy	2.22	.890	.002	6.58	.777	.005
	Neoadjuvant Chemotherapy	2.70	.852		5.27	1.57
	Surgery	3.94	.717		3.60	1.18
	Targetted therapy	1.00			1.00

Table 4 : Dimension wise Mean Absolute and Weighted Scores*

SN	Dimension	No. of items	Mean Absolute score±SD	Mean Weighted score±SD
1.	General	7	33.70±12.43	4.81±1.78
2.	Psychological^@	8	38.85±3.66	4.86±0.46
3.	Distress	7	34.35±10.65	4.91±1.52
4.	Fearfulness	5	25.61±6.24	5.12±1.25
5.	Self	4	14.47±4.43	3.62±1.11
6.	Effect on activity	5	24.17±7.82	4.83±1.56
7.	Spirituality	7	37.26±11.09	5.32±1.58
	Total score	7 Dimensions	208.42±28.53	33.48±4.98

No competing interests reported.

Low Quality of life (QoL) in Indian breast cancer patients: a critical analysis of UP

Status:

Version 2

Abstract

Introduction:

Material And Methods:

Data collection

Sample size

Sampling technique

Inclusion and exclusion criteria

QoL instrument

Reliability and validity of data

Statistical Analysis

Result & Discussion:

Demographic characteristics of patients

Clinical and treatment associated characteristics of patients

QOL subscale domain scores in relation to demographic and clinical characteristics of the patients

Correlation between QoL subscale domain scores & demographic and clinical characteristics of the patients

QoL item score analysis

Discussion:

Conclusion:

Declarations:

References:

Tables:

Additional Declarations

Status:

Version 2