Effect of chemotherapy counseling by pharmacists on quality of life and psychological outcomes of oncology patients in Malaysia: a randomized control trial

All Malaysia patients above 18 years old in different stages of cancers which undergoing their 1th and 2nd cycles of chemotherapy and able to read were recruited. Those who had already undergone their third cycle of chemotherapy onwards, very sick and had speech and communication disorders were excluded from the study.

The list of all cancer patients who met the inclusion criteria was obtained from the cytotoxic drug reconstitution (CDR) of the Pharmacy Department of the hospital and served as a sampling frame for this study. The eligible patients were randomly assigned into the intervention and control groups from the sampling frame by using the even and odd numbers selection. The even numbers were assigned to the control group, while the odd numbers were assigned to the intervention group. Patient recruitment occurred on a daily basis and was based on the number of registered patients. It was continue until a total of 162 patients were obtained for both intervention and control groups. In order to maintain confidentiality the unique code numbers were given to each member of both the control and intervention groups and used by them in the questionnaire.

Blinding of the participants or the investigators to the allocation groups was not possible, however, the data entry and analysis were carried out by an independent team led by a statistician.

The module on ‘Managing Patients on Chemotherapy’ by Pharmacists was developed through focus group discussion (FGD) and pilot test among forty cancer patients undergoing chemotherapy which not included in the main study. The FGD was conducted based on the set of questions which are mention in Table 1. Feedback from patients during the FGD and pilot test was noted, and combined with the “Chemotherapy and You” module by the National Cancer Institute (NCI) [8, 16]. Then, the new module “Managing Patients on Chemotherapy” module was checked by a group of experts including Family Medicine, Pharmacy, Oncology, Public Health, Nutrition, and Psychology. The module covers a wide range of areas, which include information on chemotherapy, side effects of chemo drugs and how to manage common chemotherapy side-effects, how to prepare for chemotherapy (before, during and after chemotherapy), what type of food eat or not eat before, during and after chemotherapy, information on psychological aspects of patients undergoing chemotherapy; namely depression, anxiety. This new module provides evidence-based information to pharmacists in counseling patients and emphasizes the importance in spending quality time with the patients as they undergo each chemotherapy cycle. This is not being practiced currently as most pharmacists do not have any guide to refer to, and have to rely on their own knowledge and experience based on each patient’s questions and needs.

The intervention group received chemotherapy counseling by the pharmacist-in-charge of this study based on the “Managing Patients on Chemotherapy’ module during their baseline, 1st follow-up, 2nd follow-up and 3rd follow-up sessions. The intervention was takes place at designated locations in the hospital and each session is designed to last 45 min ±10 min. The psychological assessment and chemotherapy counseling was done by the pharmacist-in-charge for this study which was trained by a clinical psychologist before starting the actual study.

The patients in the control group received treatment-as-usual (TAU). This consisted of some general explanation by the pharmacist based on their own knowledge and this usually only occurs during the first cycle of chemotherapy. However, the control group received the educational module at the end of study.

All participants in the intervention and control groups responded to a validated and pretested questionnaire at baseline prior to the implementation of the chemotherapy counseling module in the intervention group and usual consultation for control group.

Patients were followed up and assessed during each of their chemotherapy cycle; which varied from 3 to 6 weeks depending on the type of chemotherapy treatment they received. The three follow ups were achieved within 3 to 5 months (12–18 weeks). Patients were recruited from July 2013 to February 2014.

Patients completed their questionnaire during each chemotherapy treatment before the chemotherapy counselling session. This process was repeated in each of the three sequential chemotherapy cycles; which were defined as 1st, 2nd and 3rd follow-up sessions in this study. However, each patient completed their questionnaire at different times according to their chemotherapy treatment. Figure 1 provides the participant CONSORT diagram of both the intervention and control groups.

All questionnaires were administered in Malay using validated translated versions of the original instruments [17‐19].

The Rosner’ formula (n = [zα√pq(1 + 1/k) + zβ√p1q1 + p2q2/k]2/Δ2) was used for sample size estimation [22]. In order to achieve 80% power (2-sided alpha P = 0.05) to detect a group differences 69% [23] with 10% attrition rate, 81 cancer patients in each arm were required.

The study protocol was approved by Ethics Committee of faculty of medicine & health science, Universiti Putra Malaysia (Ref No: UPM/TNCPI/RMC/1.4.18.1 (JKEUPM)/F1), as well as director of the selected hospital. This study was registered with the National Medical Research Register (NMRR) of Malaysia and given a registration number NMRR-12-1057-12,363. A written informed consent was taken before performing the study.

Analyses were conducted with statistical computer software of SPSS version 20 (IBM SPSS Statistics 20). The outcomes of interest were quality of life and each domain included (physical health, psychological health, social relationships and environment). Frequency, percentage, mean and standard deviation were used to describe the socio-demographic characteristics of the intervention and control groups. Normality of data was examined by using the Kolmogorov-Smirnov test and all data were normally distributed (p > 0.05). At baseline, the independent samples t-test and Chi-square were used to comparison between the control and intervention groups. Two- way repeated measures ANOVA test was employed to look at the main and interaction effects within and between groups for mean scores of QOL (physical health, psychological health, social relationships and environment) and mean scores of psychological effect (anxiety and depression). It used partial eta squared (η²) as a measure of effect size which represents the variance proportion in the dependent variable (depression, anxiety, quality of life) that can be explained by the independent variable (received intervention or not). The interpretation of the strength of eta squared values used the guidelines by small effect (0.01), moderate effect (0.06), and large effect (0.14) [24]. Confidence interval was set at 95% for the estimation of odds ratio and mean. Post hoc analysis was used to find where the significant differences actually occurred in the group time at new p-value of ≤0.005 after Bonferroni adjustment. A significance level of p ≤ 0.05 was used in all analyses.

The cancer patients (n = 161) who participated in this study were assigned to the intervention (n = 81) and control (n = 80) groups. The majorities of participants were Malay 84(52.2%), Muslim 84(52.2%) and married 116(72.0%). With regards to educational level, 88(54.7%) of them were diploma & less than diploma and 40(24.8%) were illiterate. The average age of the respondents was 65 years (mean = 65.49 ± 1.4; 95% CI = 64.08–66.90) and majority of them 87(54.0%) don’t have family history of cancer. At baseline, no significant difference was found between the study groups regarding participant characteristics (p > 0.05) (Table 2).

Table 3 compares the mean scores for quality of life and each domain between the intervention and control groups at baseline until 3rd follow up. At baseline, there were no statistically significant differences between total mean score of quality of life (t = 0.54; p = 0.58), physical health (t = 0.63; p = 0.52), psychological health (t = −1.10; p = 0.27), social relationships (t = 1.63; p = 0.10) and environment (t = 0.64; p = 0.52) between the intervention and control groups. However, the mean differences of quality of life 81.95(95%CI 62.11–101.80; p = 0.000), physical health 21.01(95%CI 15.75–26.26; p = 0.000), psychological health 15.07 (95%CI 9.62–20.51; p = 0.000), social relationships 24.79(95%CI 18.92–30.67; p = 0.000) and environment 21.07(95%CI 15.86–26.29; p = 0.000) for the intervention group was significantly higher compared to the control group from baseline until 3rd follow up.

The results of the two way repeated measures ANOVA analysis for each domain of QOL on both groups (intervention and control) and time (baseline until 3rd follow up) effects and interaction between group and time showed that; in physical health, there were significant main effects for group (F = 62.41, p = 0.001, partial Ƞ² = 0.28), time (F = 78.92, p = 0.001, partial Ƞ² = 0.33) and interaction between group and time (F = 311.56, p = 0.001, partial Ƞ² = 0.66), in psychological health, there were significant main effects for group (F = 29.85, p = 0.001, partial Ƞ² = 0.16), time (F = 101.42, p = 0.001, partial Ƞ² = 0.39); and interaction between group and time (F = 295.19, p = 0.001, partial Ƞ² = 0.65). Regarding social relationship, there was significant main effects for group (F = 69.58, p = 0.001, partial Ƞ² = 0.30), time (F = 42.32, p = 0.001, partial Ƞ² = 0.21) and interaction between group and time (F = 301.93, p = 0.001, partial Ƞ² = 0.30). Finally in environment also, there was significant main effects for group (F = 63.74, p = 0.000, partial Ƞ² = 0.29), time (F = 69.50, p = 0.001, partial Ƞ² = 0.30) and interaction between group and time (F = 321.12, p = 0.001, partial Ƞ² = 0.67).

Table 4 compares the mean scores for psychological effects (anxiety, depression) between the intervention and control groups at baseline, until 3rd follow up. At baseline, there were no significant differences of anxiety (t = −1.16; p = 0.24) and depression (t = 0.72; p = 0.47) between the intervention and control groups. However, the mean differences of anxiety −0.31, (−0.59–0.03; p = 0.028) and depression −0.56, (−0.85–0.27; p = 0.000) for the intervention group was significantly lower compared to the control group from baseline until 3rd follow up.

The results of the two way repeated measures ANOVA analysis for anxiety and depression on both groups (intervention and control) and time (baseline, until 3rd follow-up) effects and interaction between group and time showed that; in depression, there were significant main effects for group (F = 14.93, p = 0.001, partial Ƞ² = 0.09), time (F = 41.88, p = 0.001, partial Ƞ² = 0.21)) and interaction between group and time (F = 103.40, p = 0.001, partial Ƞ² = 0.40). In anxiety also, there were significant main effects for group (F = 4.95, p = 0.028, partial Ƞ² = 0.03), time (F = 73.09, p = 0.001, partial Ƞ² = 0.31); and interaction between group and time (F = 47.90, p = 0.001, partial Ƞ² = 0.23).

To find out where the actual differences occurred pairwise comparison of baseline until 3rd follow up on QOL and physical effect scores was conducted. The differences in satisfaction scores were considered significant at p = 0.005 level (2-tailed) after Bonferroni adjustment. Regarding QOL, in all four domains of QOL (physical health, psychological health, social relationships and environment), the statistically significant differences were noted over time (p < 0.000). In psychological effects (anxiety, depression), the statistically significant differences for anxiety were noted over time (p < 0.000). Regarding depression, the statistically significant differences were noted over time (p < 0.000) except 1st to 2nd follow up (p = 0.11), 1st to 3rd follow up (p = 1.00).

Both groups of control and intervention were matched in terms of socio-demographic and clinical factors at baseline (p > 0.05). There was a significant change between both groups in each domain of QOL (physical health, psychological health, social relationships, and environment) and psychological effect (anxiety and depression) scores from baseline until 3rd follow-up after each counselling session (p = 0.000). From the analysis, it is concluded that repetitive counselling by pharmacists was effective in improving each domain of QOL, and decreasing anxiety and depression for cancer patients.

Quality of life is one of the most important concerns for cancer patients and survivors [25]. The results of the current study indicated that after counseling, the QOL of cancer patients in the intervention group significantly differed from the control group at all follow-ups. This significant difference verified the importance of repetitive counselling based on the “‘Managing Patients on Chemotherapy’” education module on improving QOL for cancer patients. In this regard, in western countries, many clinical practice guidelines have been developed for health care teams in psychotherapy and supportive care for improving QOL of cancer patients [26]. No significant changes were found in the QOL among the control group in this study. The findings of this study were found in line with studies done in India [27] and Iran [28] which reported that QOL of patients were improved after providing counseling for them. On the other hand, the significant difference in mean scores of psychosocial dimension of the QOL after consultation in the intervention group agrees with the results of the previous studies [29, 30]. Rehse and Pukrop [31] conducted a meta-analysis of 37 controlled studies and proves this issue, that counselling improve quality of life among cancer patients. Result of other meta-analysis study also supported the fact that education initiatives in the form of repetitive counselling by pharmacists can help in improving the cancer patient’s quality of life [30]. Detmar and colleagues [32] demonstrated that counselling by physicians made positive effects on cancer patients in regards to physiological health and physical health [32]. Also, Cappiello [33] believed that cancer patients experience many physical disorders during their treatment which can affect their QOL, and patients need support and counselling to cope with their condition.