A Prospective Study to Assess the Treatment Satisfaction and Quality of Life in Patients Receiving Chemotherapy for Adult Solid Tumors at A Tertiary Care Center, HBNI, Mumbai

Background: Treatment satisfaction and Quality of life are gaining importance for patients with cancer as the survival is improved with newer treatment modalities. Improved treatment satisfaction leads to better compliance and improved survival.

Methods: The current study is an investigator-initiated prospective study in 300 adult solid tumor patients planned for receiving chemotherapy on a daycare basis to assess the treatment satisfaction and QOL using the FACT-G questionnaire between. Our secondary endpoints included assessment of the QOL in patients receiving chemotherapy for adult solid tumors and comparing the level of treatment satisfaction and QOL of patients and also to correlate between the treatment satisfaction of patients and the socio-demographic variables.

Results: The stage 1 pilot study of 30 patients showed the reliability of the treatment satisfaction tool for respective domains and the Functional Assessment of Cancer Therapy - General (FACT G) tool for respective domains with a Cronbach’s alpha coefficient of >0.70.

The stage II study of all 300 patients showed that 151 (50%) patients were moderately satisfied with the treatment details provided, while the total satisfaction of the QOL in all the respective domains that is physical well-being, social well-being, emotional well-being and functional well-being showed that majority of the patients (50.7%) were moderately satisfied with their quality of life. There was a statistically significant moderate positive correlation between the treatment satisfaction scores and the quality-of-life domains (ρ (rho) = 0.445; p<0.001). The correlation between treatment satisfaction and various socio demographic variables showed there was no correlation between variables like age (p-value: 0.706) and sex (p-value: 0.689), whereas variables like Education status (p-value <0.00), Monthly Income (p-value <0.00), Day Care (p-value <0.00), and site of primary cancer (p-value <0.00) showed a statistically significant correlation.

Conclusion: Treatment satisfaction plays an important role in improving the quality of life of the patients. However, treatment satisfaction depends upon the education status and economic status of the patients, along with site of primary cancer and site of administration of chemotherapy.

GLOBOCAN has estimated that 1·1 million new cancer cases and 0·78 million cancer deaths occurred in India in 2018. The most commonly observed cancers in both sexes were breast (14%), lip oral cavity (10.4%), cervix uteri (8.4%), lung (5.9%), stomach (5%), and other cancers (56.4%) [1]. A significant proportion of these patients present with stage IV where treatment often takes place over prolonged periods of time.

The escalation in the health care costs has intensified the challenges in cancer treatment [2]. The cost of cancer care treatment is increasing faster than most other health care costs because of several other factors such as the increasing prevalence of cancer due to the overall aging of the population, better control of some causes of competing mortality, and the adoption of more expensive diagnostic tests [3]. Studies have shown that patients desired more information regarding their treatment effectiveness or the alternative prevailing treatment, the toxicities related to the treatment, and the costs of their treatment [4].

Several side effects of chemotherapy like nausea/vomiting, oral ulcers, and fatigue [5-7] may affect patient preferences based on risks/benefits of chemotherapy and their decision to continue chemotherapy determining their satisfaction of the therapy [8].  These patients face significant emotional disturbances attitudes [9] and care expectations from physicians’ nurses may have a direct impact on their satisfaction [10].  Oncology nurses have a significant multipronged role in treatment execution, assessing physical and emotional status of the patient, patients and families’ education, and clinical research participation and many other aspects [11]. Better the patient satisfaction, higher the treatment compliance and in term outcomes [12,13]. especially in patients with advanced stages of cancer. The level of patient satisfaction mirrors care-quality and communication between caregivers and patients [14].

Cancer, and its treatment affect the quality of life (QoL) [15,16].  Few studies suggest a link between QoL and patient satisfaction [12,13]. We have conducted this prospective study to assess the treatment satisfaction and QOL in patients receiving chemotherapy for adult solid tumors at our institute. 

The current study is an investigator-initiated prospective study to assess the treatment satisfaction and QoL in patients receiving chemotherapy for adult solid tumors at our institute between. Other inclusion criteria were age >= 18 yrs, Eastern Oncology Cooperative Group Performance Status (ECOG PS) – 0/1, planned for chemotherapy on a daycare basis, and willingness for regular follow-up as required. Exclusion criteria were prior history of another cancer or the ones having psychiatric affection. Patients provided written informed consent and the study was approved by the institutional review board  . All patients after written consent were given a questionnaire prepared on 6 domains that included counselling, cost, side-effects, nutrition, hospital and emergency services and follow- up information to assess the treatment satisfaction. The QOL was assessed with the standardized FACT-G tool after seeking permission from FACIT.org. Sociodemographic and clinical data were recorded at the time of enrolment. The study was conducted according to the principles of the Helsinki Declaration, and guidelines for good clinical practice.

A stage 1 pilot study was conducted on 30 samples to assess the feasibility of the Treatment Satisfaction tool and QOL tool and was found to be feasible. A total of 300 patients were included in the stage 2 part of the study. The convenience sampling method was done for collecting the participants who were diagnosed with solid tumors and who were to receive 1st cycle chemotherapy.

Data were analyzed using SPSS Statistics, v 21 (IBM Corp). Qualitative variables like range, frequencies, percentages and quantitative variables like means and standard deviations were calculated. Cronbach’s alpha was estimated whenever possible to asses each multi-item scale’s internal consistency. Spearman rank correlation was used to test the correlation between the treatment satisfaction scores and the overall QOL. A p-value <.05 was considered statistically significant. The question "Considering everything, how would you rate your overall experience", and a three-point scaled response from "Mildly satisfied" to "Very satisfied” were used. Multivariate logistic regression analysis method was used to estimate the prognostic significance of those clinical, demographic, and QoL.

Our primary endpoint was to assess the treatment satisfaction in patients receiving chemotherapy for adult solid tumors at a tertiary care center. Our secondary endpoints included assessment of the QOL in patients receiving chemotherapy for adult solid tumors and comparing the level of treatment satisfaction and QOL of patients and correlating between the treatment satisfaction of patients and the socio-demographic variables. The study was registered with Clinical Trials Registry – India (Number - CTRI No is 2020/031853).

Stage I

The stage I pilot study included 30 patients. It was carried out in the day care settings. Patients who were to receive the 1st cycle of chemotherapy was selected. Explanation provided and informed consent obtained.  Supplementary table 1 shows the reliability of the treatment satisfaction tool for respective domains. The Cronbach’s alpha coefficient was found to be >0.70, indicating good internal consistency.

Supplementary table 2 shows the reliability of the Functional Assessment of Cancer Therapy - General (FACT G) tool for respective domains. The Cronbach’s alpha coefficient was found to be >0.70, indicating good internal consistency. Table 1 shows the discriminant validity correlation.

Table 1: Discriminant Validity Correlation (n=30).

Table 2: Analysis of data with regard to the treatment satisfaction in patients receiving 1st cycle chemotherapy (n=300)

Stage II

Mean age of the cohort was 43 and 52% were females. 34.3% of the patients had gastrointestinal tract cancer followed by 25% of patients with breast cancer. The baseline demographic profiles of all 300 patients included in the study are summarized in Supplementary table 3.

Treatment satisfaction results of all 300 patients are summarised in Table 2. Results highlight those 137 (46%) patients were highly satisfied, 151 (50%) patients were moderately satisfied and 12 (4%) patients were mildly satisfied with the treatment provided.

The high and moderate satisfaction levels indicate the good amount of information provided in the day care areas. The total satisfaction of the QOL in all the respective domains that is physical well-being, social well-being, emotional well-being, and functional well-being showed that 73 (24.3%) were highly satisfied, 152 (50.7%) was moderately satisfied and 75 (25%) were mildly satisfied. Thus, the overall result showed that the majority of the patients were moderately satisfied with their quality of life. The detailed results are tabulated in Supplementary table 4.

Spearman rank correlation was used to test the correlation between the treatment satisfaction scores and the overall quality of life. There was a statistically significant moderate positive correlation between them (p (rho) = 0.445; p < 0.001) i.e., there exists a positive correlation between them. Hence there was statistical significance between treatment satisfaction and quality of life. The detailed correlation is tabulated in Supplementary table 5.

The correlation between treatment satisfaction and socio-demographic variables is described in Supplementary table 6. There was no correlation between treatment satisfaction and socio-demographic variables like age (p-value: 0.706) and sex (p-value: 0.689), while socio-demographic variables like education status (p-value <0.00), Monthly Income (p-value <0.00), Day Care (p-value <0.00), and site of primary cancer (p-value <0.00) showed a statistically significant correlation.

Patients' satisfaction with their care is an essential quality indicator. We conducted this study to assess patient satisfaction with care at our cancer treatment hospital and found a positive association with self-reported QoL. One possible explanation could be that more satisfied patients might experience positive emotions that may favourably influence biologically relevant factors.

Our study showed that most of the patients (50%) being treated in our tertiary care hospital were moderately satisfied with the treatment details provided followed by 46 % being highly satisfied. A study by Zissiadis Y. et al was conducted to assess patient satisfaction with the information they were receiving from their radiation oncologist on the aspects such as radiotherapy service and the level of patient anxiety both prior to and following radiotherapy [18]. The study showed that the majority of patients were satisfied/very satisfied with the explanations of their illness and the expected toxicities and few patients were satisfied with the explanation of lifestyle changes such as diet, exercise, smoking, and practical issues such as parking and treatment costs. Bhanu Prakash stated patient satisfaction as a state of mind. Patient satisfaction was not just a representation of doctors and hospital evaluation services but an effective indicator to measure quality of care and it is not just sometimes but consistently and uniformly to all patients [27].

In comparison with socio-demographic variables, it was found that patients from private daycare were highly satisfied (90.7%) and general day Care were moderately satisfied (91.3%). The patients with university/ degree education (76.0%) and higher school education (59.8%) were highly satisfied compared to less educated patients. A similar finding of the level of satisfaction with education level was found in a study by Bredart A et al. from European and Asian countries [19].  Satisfaction level was less among uro-oncology patients compared to other cancer patients in line with a national survey conducted in cancer patients in England where prostate cancer patients expressed the greatest dissatisfaction. The same study found greater dissatisfaction in younger and female patients, however, there was no significant difference in satisfaction as per age and gender in our study [20].

Assessment of QOL using FACT-G demonstrated that most patients (50.7%) receiving 1st cycle of chemotherapy had moderate QOL followed by low QOL in 25% and high QOL in 24.3% of the patients. A similar cross-sectional analysis by Chagani P et al to assess the QOL using FACT -G and its determinants in adult cancer patients undergoing chemotherapy treatment showed a majority of patients had poor QOL, more so in the female gender, unemployed patients, and parents as caretakers of the patients [21].  Most of the patients had low to moderate scores for emotional well-being in our study similar to another study from south India on oral cancers [22].

In our study, we could find a statistically significant (ρ (rho)= 0.445; p< 0.001) correlation between QOL and treatment satisfaction. Mékiès C et al [23] in his study demonstrated patients’ satisfaction was associated with a better self-rated quality of life. This implies that QOL of life not only depends on the therapy but also on how the treatment process/ modality has been explained to the patients. On the contrary, some studies failed to demonstrate correlation between QoL and patient satisfaction [24-26].

Limitations of our study

Limitations of the current study are that the study only targeted the adult population with various diagnoses and diverse treatment protocols and not the caregivers of the pediatric population, the treatment satisfaction tool focused only on the information provided, and the fact that the study included only the patients who received 1st cycle chemotherapy. Thus, the results may or may not generalize to long-term patient satisfaction for patients undergoing care for cancer. Also, a convenience sample size was used and not a statistically calculated sample size.

Recommendations for future research

Based on the findings of the study, the investigator wants to recommend further studies: an interventional study can be done to assess the knowledge and understanding level of the information that is provided to the patients and their QOL. A study can be done on a larger scale of a specific diagnosis and chemotherapy protocol to assess the treatment satisfaction and QOL. A similar study can be conducted to assess QOL over a period of multiple cycles. A similar study can be done on the treatment satisfaction of the patients who underwent surgery.

Our study highlights the importance of effective communication with the patients to satisfy the patients about their cancer diagnosis and modality of treatment to improve the QOL. Patients with lower education levels need more information to make them satisfied with the ongoing treatment. Meeting the psychological needs of these patients will help them undergo the treatment with confidence and follow the protocols meticulously, which will definitely increase the treatment outcomes and prognosis.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.