Effect of a nurse-led pre-chemotherapy education programme on quality of life and psychological distress of patients with breast cancer; a pilot based randomized controlled trial

INTRODUCTION

Breast cancer, succeeding lung cancer, occupying second rank among the most common malignancies around the globe. The age standardized rate (ASR) of the breast cancer is highest in the Australia and New Zealand (94.2 cases per 100,000 population) and lowest ASR is seen in the South-Central Asia 26 cases per 100,000).¹ The lifetime risk of developing breast cancer is three times higher in developed countries than low-income countries. In India, the breast cancer accounts for 14% of cancers in women. The highest numbers of breast cancer are recorded in state of Kerala, Mizoram, Haryana, Delhi and Karnataka.²

Quality of life is a comprehensive term used to assess life in multiple spheres of life, including physical functioning, psychosocial status, and role functioning. Over the past 30 years, nurse scientists have viewed and kept quality of life as an important indicator for evaluating health care outcomes, because state of well-being matter for quality of life, not quantity of life lived in years.³

Most of the breast cancer patients receive chemotherapy as treatment protocol. Patients receiving chemotherapy experience multiple symptoms that can be very distressing to them. This is why cancer patients’ symptoms are taken as ‘symptom burden’.⁴ Patients get afraid because of some unauthentic information or advice from lay persons. It causes more stress and anxiety about treatment. Furthermore, educated people explore knowledge on internet, as they are not well aware about authentic official sites of cancer and jeopardised themselves.

Lack of awareness about disease and its treatment especially chemotherapy create worry and fear of altered physiological functions and disturbed body image. Moreover, it is difficult for the health care professionals in OPD to pay enough consideration to the patients’ concerns and queries because of high patient burden. Currently, the Indian medical system is lacking standard practice of nurse-led pre-chemotherapy education programme. Its’ existence is functioning at infancy level. Pre-chemotherapy education actually prepare breast cancer patients for the long journey where they have to fight with many side effects and learn early identification and tackle them at home with altered dietary practices.⁵

The current study is an attempt to address the issues regarding preparedness of patients with breast cancer before chemotherapy by educating them to self-manage at home and reducing psychological distress. Further, the findings of this study can also support the need to develop structured nurse led cancer clinics in all settings to enhance quality of life among patients with breast cancer.

Hypothesize that nurse-led pre-chemotherapy education programme can improve quality of life and reduce psychological distress among breast cancer patients receiving chemotherapy at 0.05 level of significance.

METHODS

The study was conducted in the Medical oncology wards and Day care centre of all India institute of medical sciences, Rishikesh, Uttarakhand from August 2019 to December 2019. It is a tertiary care autonomous institute with a capacity of 1060 beds provides comprehensive, high-quality care to patients with advanced technologies.

Trial design

The study was a prospective, randomized controlled, parallel group design and single centric study conducted with 1:1 per allocation regimen. The study was registered with clinical trial registry of India, with registration number: REF/2019/05/025755.

Ethical considerations

The study was approved by institutional ethical committee. Written informed consent was obtained from all the participants. The confidentiality of information was ensured to the participants.

Participants

Eligibility criteria for participants: Female patients, newly diagnosed with breast cancer and receiving chemotherapy for the first time, having normal hematopoietic, hepatic, renal, cardiac and lung functions at the time of patient enrolment, with 0-2 performance status (ECOG), patients who can read and understand Hindi or English and between 18 years and 70 years of age. The participants with clinically diagnosed mental illness, and had already received chemotherapy or receiving concurrent chemo-radiotherapy were excluded from the trial.

Instruments

European organization of research treatment of cancer quality of life questionnaire (EORTC QLQ-C30): The primary outcome of the study was quality of life among patients with breast cancer receiving chemotherapy. European organization of research treatment of cancer quality of life questionnaire and with breast cancer supplementary module version 3.0 (EORTC QLQ-C30) was used to assess the quality of life of the participants.

It is a standardized tool for evaluating the quality of life (physical, psychological and social functions) of patients participating in clinical trials. It consists of 30 questions regarding activities of the past week. It is divided into three domains: global health (n=2), functional scales (n=15), and symptom scales (n=13). A high score for a functional scales and global health status represents a high or healthy level of functioning whereas high score for a symptom scales represents a high level of symptomatology or problems.⁶ The content validity of the tool was established by a panel of ten experts from the field of medical oncology, surgical oncology, gynaecology, oncology nursing and medicine. The permission was obtained to use the standardised tool in Hindi and English language. The reliability of the tool was calculated due to different research setting, with Cronbach’s alpha coefficient and tool was found reliable with r=0.91

Hospital anxiety and depression scale (HADS): This tool was used to assess the psychological distress amongst the participants. The HADS is a self-reported, 14 items measure with two sub scales (anxiety HADS-A and depression HADS-D), which may be scored by the scale or as a total score representing overall distress. Total scores can range between 0 and 21 for either anxiety or depression. The level of anxiety and depression was classified as normal (0-7), borderline abnormal (8-10) and abnormal (11-21).⁷ The reliability of the tool was calculated due to different research setting with Cronbach’s alpha coefficient and tool was found reliable with r=0.8. The tool was translated in Hindi and then re-translated in English language by language experts.

Sample size

The sample size was calculated by taking the reference of parameters of previous study by using G*power software.⁸ With 90% power (5% significance) to identify differences of at least 12% in quality of life using the European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-C30), the sample size resulted 72 participants and after adding 10% drop out rate, it comes with 80 participants. (40 in each group). However, 30 participants have been selected to conduct pilot study to estimate a parameter.⁹ Purposive sampling technique was used to draw sample from the target population.

Random allocation

The random allocation sequence was produced online by sealedenvelope.com. Allocation to each group was conducted in a block randomization manner with a block size of four. The allocation concealment mechanism was developed with predetermined sequences written on paper slips and kept in a sealed opaque envelope. Each envelope had a unique code written and arranged sequentially as per the randomized list. An assigned person, who was not involved in the study, managed the random allocation sequence and it was kept concealed from the researcher. The participants were enrolled after meeting eligibility criteria and written informed consent. Baseline information on primary and secondary outcomes of eligible participants was obtained before allocation. The researcher opened the sealed envelope, and at the same time, participants received their information on allocation to the ChemoED group and control group.

Blinding

It was an open trial study. Patients and researcher allocated to an experimental and control group were aware of the allocated arm.

Intervention

The extensive review of literature on PubMed, Mendeley, Google scholar and Embase, and expert’s opinion, focused group interview with patients led the development of intervention. An educational booklet to be given to the participants was prepared. It consisted of 9 chapters including introduction to breast cancer, breast self-examination, post-mastectomy exercises and prevention of lymphedema, chemotherapy, pre-chemotherapy preparation, management of various side-effects at home, thoughts and feelings, information for relatives and friends, day to day living. Validation of the booklet was done by giving it to experts in oncology, gynaecology, dietician, nursing and psychiatry. Necessary modifications were done by incorporating their valuable suggestions after discussion with the guide.

Data collection procedure

Baseline information related to demographic profile, clinical, and obstetric profile was obtained from both groups. Pre-interventional quality of life and psychosocial distress was measured with EORTC QLQ C-30 and HADS for both experimental and control groups.

Following this, the nurse Led pre-chemotherapy education (ChemoED) Programme was administered to the participants included in experimental group. It consisted of two steps: a) Twenty minutes of pre-chemotherapy education programme was implemented to the patients enrolled in the experimental group. It was conducted in a separate room before the administration of first cycle of chemotherapy to the patients. The educational booklet was provided to the patients after clarifying their doubts. b) Telephonically follow up was done with each participant, after one week of the chemotherapy cycle to motivate them to get adhere to the information given in booklet. Participants in the control group were given standard nursing care including nursing assessment and basic care while providing chemotherapy and routine information related to side-effects and follow-up treatment. At 4^th cycle of chemotherapy, quality of life and psychological distress was assessed for the participants of both the groups.

Statistical analysis

Data was coded and analysed by SPSS version 23.0 through descriptive statistics (frequency, percentage, Mean, SD) and inferential statistics (independent t test, paired t test and Chi square).

RESULTS

Table 1 illustrates characteristics of the patients in terms of socio-demographic and clinical variables: Mean age of patients in experimental group was 46.2±9.2 and in control group was 45.8±10.4. Both the groups were comparable in terms of homogeneity except working status and staging of cancer at p<0.05.

Table 2 depicts the mean difference in global health status among experimental and control group at baseline and chemotherapy cycle four. The mean scores (at baseline) in both groups were comparable (p=0.45). After the intervention (at cycle four), there was statistically significant difference in the global health status in both groups with mean difference 23.4 at p=0.00.

^Ψ T-test of two independent samples; ^#Chi-square/Fisher’s exact test; ^ζMann-Whitney U test; bold numbers represent statistical significance at 5% level

^**significant p<0.05 Higher score depicts good quality of life (global health status)

The functional scores (Table 3) represent that in experimental group at chemotherapy cycle four, the mean difference has increased from baseline values reflecting higher quality of life but results were not statistically significant except Role functioning (p=0.03). However, in control group, a significant reduction in functional scores was observed at chemotherapy cycle four from baseline values, indicating poor quality of life in control group. Mean scores has significantly reduced from baseline in domains of physical functioning (p=0.03), cognitive functioning (p=0.04) and social functioning (p=0.03).

The symptoms scores (Table 4) depict that after intervention, mean symptom scores at chemotherapy cycle four, has increased from baseline scores, but this difference in mean score is statistically non-significant except Fatigue (p=0.03). In contrast, control group has exhibited a highly significant change in terms of increased mean scores at chemotherapy cycle four as compared to baseline values. Thus, indicating poor quality of life in terms of increased fatigue (p=0.01), nausea and vomiting (p=0.00), constipation (p=0.00), diarrhoea (p=0.00) and financial difficulties (p=0.00).

^*Significant, Higher functioning scores depicts good quality of life

^*Significant p<0.05 higher symptom scores depict high level of symptomatology

^*Significant p<0.05

Table 5 showed the effect of intervention on quality of life in experimental and control group. At chemotherapy cycle four, mean differences in both the groups indicating significant improvement in quality of life among experimental group as compared to control group in terms of global health status GHS (p=0.00), physical functioning (p=0.00), role functioning (p=0.00) and cognitive functioning (p=0.00). The symptom score was significantly reduced in experimental group as compared to control group. The minus sign in mean differences indicates reduction of symptoms in experimental group. There was statistically significant reduction in following symptoms: nausea and vomiting (p=0.05), pain (p=0.05), sleep disturbances (0.01), appetite loss (0.03), constipation (0.01), diarrhoea (0.03) and financial difficulties (p=0.03).

Table 6 represents changes in mean HADS score from baseline to chemotherapy cycle four in experimental group. The mean HADS scores (anxiety and depression) at chemotherapy cycle four (10.3±7.5) has reduced from baseline scores (15.1±8.6) after intervention. However, this reduction in scores was statistically non-significant (p=0.11).

^*Significant p<0.05

On the contrary, in control group, (Table 7) mean HADS scores has increased from baseline scores (13.8±11) and at chemotherapy cycle four (15±7.5) with mean difference (-1.2). However, this difference was statistically non-significant (p=0.72).

Table 8 depicts that effect of intervention on HADS score among experimental group and compare it with control group at chemotherapy cycle four. The mean HADS score at baseline in experimental and control group was non-significant (p=0.72). However, after intervention, mean

HADS score were significantly less among experimental group (10.8±15) as compared to control group (15±7.5) with mean difference 4.2 (p=0.05).

DISCUSSION

The newly diagnosed patients with cancer feel stress and worry of being diagnosed and on the top of that, chemotherapy treatment and its various side-effects lead to anxiety among the patients. Moreover, if patients lack adequate knowledge about the disease and treatment and how to self-manage at home, fear of commencing chemotherapy affect quality of life and create psychological distress in the patients. Quality of life is a comprehensive and subjective phenomenon about ways of living of a patient with cancer. The diagnosis of breast cancer itself develops burden among patients and their family members in terms of physical sufferings, psychological distress and economic burden.

Psychological distress is an unpleasant and emotional suffering experienced by person that may interfere with his ability to cope with disease or symptoms effectively.¹⁰ The current study was carried out on newly diagnosed females with breast cancer receiving chemotherapy for the first time in life. The results showed that Nurse-led pre-chemotherapy education programme has not only enhanced the global health status, but also quality of life pertaining to various domains of health. After the intervention, the global health status (p=0.00), physical functioning (p=0.00), role functioning (0.00), and cognitive functioning (0.00) has shown significant improvement in quality of life as compared to control group. Nonetheless, social functioning and emotional functioning has not improved significantly. The educational intervention has heightened their awareness about disease, treatment and also made patients psychologically strong enough to accept themselves as they are and combat with illness.

However, the symptomatology scores have statistically significantly reduced after the intervention at cycle four as compared to control group in terms of nausea and vomiting (p=0.05), pain (p=0.00), sleep disturbances (p=0.01), appetite (0.03), constipation (p=0.01), diarrhoea (p=0.03) and financial difficulties (p=0.03). Loh et al stated that the quality of life, including all domains significantly increased in intervention group after implementing one month self-management programme compared to control group (p<0.001).¹¹ Similar findings have also been reported by Park et al, Sharif et al and Matsuda et al wherein educational intervention has significantly improved quality of life among patients receiving chemotherapy.^12-14 Results of the current study regarding HADS at baseline were well balanced between the two groups (p=0.72). After the intervention, the psychological distress has significantly reduced at cycle four in experimental group compared to control group (p=0.05). The results are supported by the findings of study conducted by Cox et al, Zhu and Aranda et al wherein there was significant reduction in psychological distress with education intervention (p=0.027).^15-17 Despite of technological advancement in treatment and survival, cancer remains a dreaded diagnosis and produced distress along the continuum of cancer. This distress is a combination of multidimensional stressors that strain the patients’ and family coping capabilities.

Pre-chemotherapy education sessions significantly increased the global health status and functioning of patients and similarly there was significant reduction in symptom burden and psychological distress as compared to control group in the present study. With better understanding of diagnosis, goals of treatment, potential side-effects and management strategies, patients have reported reduced anxiety and depression associated with chemotherapy and further have better quality of life and better clinical outcomes. This knowledge can be well enhanced by oncology nurses by providing individual educational sessions either by giving written material for educated people or some animated videos for other ignorant patients.¹⁸

The findings of the current study have depicted the importance of pre-chemotherapy education for the patients with breast cancer undergoing chemotherapy. Thus, the oncology nurses can meet the educational and psychosocial needs of newly diagnosed patients with cancer and are going to be started with chemotherapy.

Limitations

The current study was limited to thirty patients from one hospital only. So, selection bias could not be completely omitted. The weakness of study is that we have to rely on patient’s responses on adherence to guidelines provided in educational booklet. However, telephonically follow up was done to remind them to read booklet and follow the content of booklet.

CONCLUSION

Newly diagnosed patients with cancer usually suffers with psychological distress, which can trouble their quality of life. Embedding authentic information along with treatment modalities may improve quality of life and psychological distress among patients. Nurse-led pre-chemotherapy education programme can be cost-effective and practical method to improve patients’ preparedness to get chemotherapy. It will also empower the specialised nurses to provide utmost quality patient-centred care.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the Institutional Ethics Committee

REFERENCES

1. 1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424.
2. 2. American Cancer Society. Breast Cancer Facts and Figures 2019-2020. Atlanta: American Cancer Society, Inc. 2019.
3. 3. Dubashi B, Vidhubala E, Cyriac S, Sagar TG. Quality of life among young women with breast cancer: Study from a tertiary cancer institute in South India. Indian J Cancer. 2010;47(2):142-7.
4. 4. Cleeland CS. Symptom Burden: Multiple symptoms and their impact as patient-reported outcomes. JNCI Monographs. 2007;37:16-21.
5. 5. Rani R, Kaur S. Nurse-led clinics in India, an innovative approach in patient management. Int J Adv Res. 2019;7(9):1190-92.
6. 6. Ho PJ, Gernaat SA, Hartman M, Verkooijen HM. Health-related quality of life in Asian patients with breast cancer: A systematic review. BMJ Open. 2018;8(4):e020512.
7. 7. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361-70.
8. 8. Galiano-CN, Cantarero-VI, Fernandez-LC, Ariza-GA, Diaz-RL, Del-Moral-AR et al. Evaluating the Impact of an Internet-Based Exercise Intervention on Quality of Life, in Breast Cancer Survivors, A Randomized Controlled Trial. Wiley Online Library. 2016;122(20):3091-248.
9. 9. Whitehead A, Julious S, Cooper C, Campbell M. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Statistical Methods Med Res. 2016;25(3):1057-73.
10. 10. Yarbro CH, Wujcik D, Gobel BH. Cancer Nursing: Principles and Practice. 8^th ed. Jones and Barlett learning, Cancer related distress. 2015;24:760.
11. 11. Loh SY, Packer T, Chinna K, Quek KF. Effectiveness of a patient self-management programme for breast cancer as a chronic illness: a non-randomised controlled clinical trial. J Cancer Surviv. 2013;7(3):331-42.
12. 12. Park JH, Bae SH, Jung YS, Kim KS. Quality of life and symptom experience in breast cancer survivors after participating in a psychoeducational support program: a pilot study. Cancer Nursing. 2012;35(1):E34-41.
13. 13. Sharif F, Abshorshori N, Tahmasebi S, Hazrati M, Zare N, Masoumi S. The effect of peer-led education on the life quality of mastectomy patients 6 referred to breast cancer-clinics in Shiraz, Iran 2009. Health Qual Life Outcomes. 2010;8(1):74.
14. 14. Matsuda A, Yamaoka K, Tango T, Matsuda T, Nishimoto H. Effectiveness of psychoeducational support on quality of life in early-stage breast cancer patients: a systematic review and meta-analysis of randomized controlled trials. Qual Life Res. 2014;23:21-30.
15. 15. Cox K, Wilson E. Follow-up for people with cancer: Nurse-led services and telephone interventions. J Adv Nursing. 2003;43(1):51-61.
16. 16. Zhu J, Ebert, L, Liu, X, Chan S. A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: Study protocol for a randomized controlled trial. BMC Cancer. 2017;17(1).
17. 17. Aranda S, Jefford M, Yates P, Gough K, Seymour J, Francis P. Impact of a novel nurse-led pre-chemotherapy education intervention (ChemoEd) on patient distress, symptom burden, and treatment-related information and support needs: Results from a randomised, controlled trial. Ann Oncol. 2012;23(1):222-31.
18. 18. Apor E, Connell NT, Faricy-Anderson K, Barth P, Youssef R, Fenton M et al. Prechemotherapy Education: Reducing Patient Anxiety through Nurse-Led Teaching Sessions. Clin J Oncol Nurs. 2018;22(1):76-82.