|Year : 2013 | Volume
| Issue : 1 | Page : 11-16
Patient-reported quality of life outcomes in Indian breast cancer patients: Importance, review of the researches, determinants and future directions
Prasanna R Deshpande1, Mohd Kazim Sheriff1, Abdul Nazir1, Sudeepthi Bommareddy1, Anil Tumkur2, Anantha N Naik2
1 Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
2 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
|Date of Web Publication||10-Apr-2013|
Prasanna R Deshpande
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal
Source of Support: None, Conflict of Interest: None
Breast cancer is a leading problem in developing world and India can be considered as one of the major contributors for incidence of breast cancer. In this article authors have reviewed quality of life studies on Indian breast cancer population. There are many factors which may hear common but cannot be neglected in case of Indian population. Policies and future directions to be implemented for breast cancer are also discussed.
Keywords: Breast cancer, India, patient reported outcomes, quality of life
|How to cite this article:|
Deshpande PR, Sheriff MK, Nazir A, Bommareddy S, Tumkur A, Naik AN. Patient-reported quality of life outcomes in Indian breast cancer patients: Importance, review of the researches, determinants and future directions. J Can Res Ther 2013;9:11-6
|How to cite this URL:|
Deshpande PR, Sheriff MK, Nazir A, Bommareddy S, Tumkur A, Naik AN. Patient-reported quality of life outcomes in Indian breast cancer patients: Importance, review of the researches, determinants and future directions. J Can Res Ther [serial online] 2013 [cited 2020 Aug 10];9:11-6. Available from: http://www.cancerjournal.net/text.asp?2013/9/1/11/110341
| > Introduction|| |
In recent decades, measurement of quality of life (QOL) in breast cancer patients has been focus of clinical practice and research and it is also gaining the importance in the assessment of treatment consequences. , Globally, breast cancer comprises 23% of all female cancers that are newly diagnosed, in over 1.1 million women each year.  Also it causes over 0.411 million deaths, which accounts for over 1.6% of female deaths from all causes per annum worldwide. 
Fifteen years ago, cervical cancer had the highest incidence in female cancers in urban areas of India but now it has been overtaken by breast cancer  and proportion of incidence is increasing day-by-day. Therefore, this disease may be considered to be a serious problem in future.
| > Importance of Patient-Reported QOL Outcomes in General and in Indian Population|| |
It is important to study QOL aspects in breast cancer patients because of chronic nature of the disease, regular follow-up by the patient, different types of treatments given (radiation, surgery and chemotherapy), influence on sexual life, motherhood and self-identity of women and suffering through the adverse effects of chemotherapy like alopecia, nausea, vomiting, weakness, etc. Clinical presentations of the disease such as presence of lump in breast, bone pain, jaundice, difficulty in breathing, and changes in mental status may also play an important role in QOL of breast cancer patients. Moreover, a woman plays vital role in the family as a wife, sister, mother, and daughter. As per Montazeri study, when a woman develops breast cancer, all family members might develop some sort of illness. 
As per United States Food and Drug Administration (USFDA) guidance, a patient reported outcome (PRO) is any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else. Some data can be obtained only from patients,for example, frequency and severity of symptom/s; psychological effects; perception or feeling toward disease, illness or treatment; impact of the disease on daily activities, etc.  As mentioned above there are many factors in breast cancer which affect QOL of the patient and only the patient can give the best information about what he/she is feeling? Therefore, it is important to determine the patient perspective about the disease, treatment and overall QOL aspects.
Indian women population differs in ethnic, social, cultural as well as economical aspects as compared with western women so it is necessary to study the factors affecting QOL especially of Indian patients. Although breast cancer is more prevalent in developed world, the mortality rates in developing world are comparatively higher.  On the other side, breast cancer is mainly a pre-menopausal disease in Asia while it is more likely to occur as a post-menopausal disease in western countries.  The studies have been carried out in Indian population to determine QOL aspects of Indian breast cancer patients and our objective was to review the same and to predict the future directions for improving the QOL outcomes.
| > Methodology for Review of Researches|| |
The research articles in English which were associated with the QOL aspects of Indian breast cancer patients were searched as per regular 'google' search irrespective of scientific search engines published in the duration between January 2000 to December 2011. The regular scientific search engines like Medline, Science Direct, EMBASE, the Cochrane library, etc., were not used for search because the number of QOL studies on Indian breast cancer population were expected to be less and we desired to retrieve maximum studies to perform a better review. Studies on breast cancer-QOL aspects on non-indian population were excluded from the study. Although it was not a systematic review, we tried to make it as systematic as possible. After selecting the articles, they were studied and the data obtained from the article were-name of first author, year of publication, instrument used for the study and possible factors affecting the QOL as shown in [Table 1]. ,,,,,,,,,,,,,,,,,,
|Table 1: Studies on quality of life and breast cancer among Indian women[11-29]|
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| > Results of the Review|| |
After reviewing the QOL studies in Indian population the unique and important factors can be predicted, which are generally not found in the western population. [Table 2].
|Table 2: Important factors affecting directly or indirectly on quality of life of Indian breast cancer population|
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After diagnosis of the disease, patient first feels depressed and frightened. India is the highest populated country in the world after China and more than one-fourth of the population is below national poverty line.  Though the estimates are from the year 2004-2005, the same cannot be less than 20% in today's world. Economical status of the patient or his family can be considered to be the vital factor in Indian patients. The occurrence of a disease to a person in the family is like a disaster for the family.
If we look at the other parts, in western countries generally the decision about the health of the woman are taken by the patient herself but in India, spouse, family background and family income play an important role in the healthcare decision making for the patient. Therefore, marital status of the patient may not be ignored as a factor affecting QOL.Moreover, a woman plays a central role in the family but there is some amount of negligence toward a woman's health in Indian families. Some kind of blushing nature and negligence toward self health is also there in Indian women as compared with the western population thus gender of the interviewer also affects while taking the information from female patients. The women may not talk frankly with a man as compared with a woman especially on gynecological issues. Number of unmarried children in the family has been observed to affect QOL of the patients.  Also, a girl child is still considered to be a burden on the parents in many Indian families.
Nearly half of the female adults (age>15years) in India are illiterate  and many women have poor knowledge about the disease, may be, because of low literacy rate. According to the Somadatta et al. study, 56% women were aware about the breast cancer, among them 53% were aware of breast cancer can be detected early; 51% of the women were aware about at least one of the signs/symptoms and only 35% of the women mentioned about the risk factors.  But the study was conducted in Delhi area and the poorer results may be obtained in other parts of India especially rural parts. In such conditions, education of spouse affects healthcare decisions taken for the woman. Because of illiteracy and less knowledge about the disease breast cancer is considered to be a social stigma in the community.
If talking about the sexual issues, women in western world are generally more concerned about the sexual life and cosmetic issues irrespective of age but it is not so observed in India. In the Dubashi et al. study, the women with breast conservation surgery showed poorer QOL as compared with mastectomy group.  No doubt that the breast cancer more/less affects the sexual or personal relationship between couples, it can lead to marital problems. Such marital problems can ultimately lead to poor QOL in the patients.
Employment and occupational status were also found to have some effect on the QOL of the patients. ,,, The employment has positive or negative effect on the QOL. Employment can give financial support to a patient but on the other side because of regular hospital visits and work load it can worsen the QOL. While for an unemployed woman financial difficulties may be there but she can go to regular hospital visits in a more convenient way than the employed woman. The friend circle at the site of employment may play a crucial task in QOL as well.
Almost 69% of the Indian population belongs to rural area  and for the treatment they need to come to cities possibly because of lack of tertiary care hospitals. The distance travelled from home to hospital found to affects the QOL of the patients as they have to come for the regular follow-up. 
Most of the studies in Indian population have used internationally recognized instruments except some of them. ,, Radiation therapy for breast cancer may cause skin pigmentation,  which is common in Asian patients, and it takes a number of years to lighten the pigmentation wholly but EORTC (European Organisation for Research and Treatment of Cancer) instrument for breast cancer does not have any question about post-radiation pigmentation of the skin.  In Indian scenario various practices are observed, which can give psychological well-being to patients in the form of meditation and spirituality. Yoga has been proved to give relief from distress. , According to the Ramanakumar study, a variety of practices related to religiosity are followed in India to overcome coping due to illness like belief in god, belief in karma, increased temple visits, increased temple activities, visiting religious place, pilgrimage, Yoga, and the belief that 'god will save'. 
In many western countries clinical pharmacy services provided by the pharmacists are common practice but they are almost not followed in India. The clinical pharmacy services include drug therapy monitoring, determination of drug interactions in the prescriptions; assessment and reporting of adverse drug reactions and last but very important patient counseling.  Patient counseling can give psychological support to the patient. Therefore, scarcity of the clinical pharmacists may also affect the QOL.
Alopecia is the common adverse effect of many anticancer drugs. Commonly, Indian women prefer to hide the complete baldness induced because of drugs. The cultural, social, and literacy aspects may be the possible reason for the same. As per the Parmar et al. study, patients were most upset on hair loss as compared with other side effects. 
Long-term survivors in breast cancer may have poor QOL because of regular hospital visits, different types of treatment, adverse effects of the treatment, depression, fear of recurrence, and financial constraints. There is need for media attention, further research in QOL, strong participation of non-governmental organizations and care groups to cope the disease for long- term survivors. 
As we know India is a highly populated country in the world; load of the patients on the healthcare system is also proportionally high and because of this physicians generally cannot give sufficient time to all the patients to know all about their problems and in fact the patient generally has a lot of questions in her mind to ask. This factor is also affecting indirectly on the QOL outcomes on the Indian breast cancer patients.
| > Conclusions from the Research Literature|| |
The following characteristics of the breast cancer patients are sufficiently well documented and can be used as a basis for planning of the future directions.
- Depression and knowledge about the disease-The root factor associated with poor QOL of the patients were found to be depression and poor knowledge of the disease.
- Patient education-There is strong need about the patient education and awareness about the disease.
- Financial support-As per studies most of the patients had and have financial constraints.
- Journey from home to hospital-It was also found to be one of the major factors affecting QOL of the patients.
- Lack of clinical pharmacists-There were almost no clinical pharmacy services in India previously but they are expected to grow well in future.
| > Discussion and Future Directions|| |
Research on breast cancer have conclusively predicted that the patients need communication with health care professionals, suitable information about the disease, advice about self help, a chance to express their feelings, etc. 
In Asia, lower mortality and incidence rates for breast cancer are recorded in eastern part as compared with western one.  The probable reasons for the higher morbidity and mortality rates in a country like India are-lack of breast cancer awareness, lack of national screening program, and poor detection methods.  In contrast, East Asian countries like Korea, Singapore, etc., have better medical facilities and management, better disease awareness, improved treatment options, and financial improvement. , In Asia, diagnostic and prognostic procedures for breast cancer are executed by means of older but still reliable technologies such as ultrasound. In fact, more advanced technologies like magnetic resonance imaging (MRI) and 21-gene reverse transcription polymerase chain reaction (RT-PCR) array are not commonly used in Asia. ,
There is a sturdy requirement for a policy to create awareness about breast examinations, that is, self and clinical examination and national screening program. Psychological support and patient education are the most significant factors for a newly diagnosed breast cancer patient and should be encouraged by the healthcare professionals. Newly emerging clinical pharmacists in India can contribute a foremost role in patient education and awareness about the disease. 
Western world take for granted that individuals are autonomous decision makers  but on the contrary in Indian scenario the decisions are generally taken by spouse or head of the family. Therefore, spouse education about the disease is very important to improve the QOL.
In treatment phase, identification of the patients who are suffering the most and individualized care should be persuaded. Monitoring of patient's QOL should be a fundamental part of the care. Many standard instruments have been used in Indian population for the determination of QOL of breast cancer patients such as EORTC and FACT-B (Functional Assessment of Cancer Therapy for Breast cancer) instruments but there is need of Indian originated tools for the same as there are many important and unique parameters observed in the Indian population. The tools should have the ideal properties such as- QOL specific; optimum number of items; should have easy and specific measurement, conceptual equivalence, proper evidences for conceptual framework, confidentiality of the patient, reproducibility; should be based on end-point model, conceptual framework.  The research in QOL aspects of breast cancer patients in India is rare and it is needed to develop for better patient care.
As per review, many patients in India have financial constraints, for such patients firm government policy and affordable health-insurance schemes should be considered. Actually, health-insurances can be a tool to overcome the financial constraints and need to be implemented by the government.
Pharmacoeconomics is the upcoming area to work. It is defined as the scientific discipline that evaluates the clinical, economic and humanistic aspects of pharmaceutical products, services, and programs, as well as other health care interventions to provide health care decision makers, providers, and patients with valuable information for optimal outcomes and the allocation of health care resources.  Application of pharmacoeconomics in breast cancer therapy may improve decision making and may help to optimize the use of scarce health care resources allocated to the patients. Spouse and family education about the disease also ought to be supported while treatment.
Many anticancer drugs cause adverse drug reactions (ADRs) and the common one are-alopecia, nausea, vomiting, weakness, dry mouth, headache, weight, nail changes, etc. There is need of drug therapy monitoring for drug-drug interactions in the prescriptions by clinical pharmacists for better patient care. The pharmacists' intervention based on chemotherapy counseling improves knowledge and satisfaction in oncology inpatients and reduces adverse drug reactions following chemotherapy treatment. 
Spiritual support and meditation are observed to be useful for coping due to breast cancer  and are supposed to be practiced. Employment of positive talk should be considered. In addition, constructive and positive talk by women with breast cancer has been described to have the potential to close down difficult conversation.  Yoga program is associated with statistically and clinically significant improvements in aspects of QOL.  Yoga should be a regular practice for the breast cancer patients. Overall, rehabilitation is recommended for the patients with breast cancer after the treatment. Recommendations for culturally appropriate, family centered models can be applied as per the Balneaves et al. study for breast cancer. 
Role of clinical pharmacists and why should it be considered separately?
Previously the role of pharmacists in Indian healthcare system was related to the work none other than dispensing of medications but upcoming PharmD candidates and M. Pharm (Pharmacy Practice) candidates i.e. clinical pharmacists could play a prominent role in future Indian healthcare system. Thousands of clinical pharmacists are expected to be a part of the healthcare system in India in upcoming years. Community pharmacists may do well in awareness programs of breast cancer. They are observed to be effective in recruiting women in public health program.  A step forward, an association named 'Association of Community Pharmacists of India' has been established recently. 
Clinical pharmacists may also play a dominant role in QOL studies in breast cancer patients and may contribute to development of the field. Through counseling they may educate the patients about the disease, drugs, lifestyle modifications, etc., Provision of clinical pharmacy services may minimize the rising load on Indian healthcare system and also of physicians, nurses, and other healthcare professionals.  Clinical pharmacy services like drug therapy monitoring, determination of drug-drug interactions, assessment and reporting of adverse drug reactions, community services  can play a significant role in the improvement of QOL of Indian breast cancer patients. Clinical pharmacists can also be recommended for pharmacoeconomics studies. Conclusively, clinical pharmacists may give the major support to Indian healthcare system in future.
| > Conclusion|| |
Breast cancer is a growing disease in India. We found many influential factors which are affecting patient-reported QOL outcomes of Indian breast cancer patients. There is need to thought of all the patient reported outcomes and problems. Further research in the area of QOL of breast cancer patients is desired. At last, patient is the center for the healthcare system, if he/she is satisfied then only the healthcare system around him/her is up to the mark.
| > Acknowledgement|| |
We would like to thank Association of Practicing Pharmacists and Clinical Pharmacologists of India (APPCPI), Association of Community Pharmacists of India (ACPI), Kautilya's Society for Pharmacoeconomics, and Outcome Research (KSPOR) for their support.
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[Table 1], [Table 2]