A nurse-led care program on quality of life and health care utilization for cancer patients in a chemotherapy day center : a randomized controlled trial

Abstract

Background: The shift from inpatient-based to outpatient-based chemotherapy has led to increasing numbers of cancer patients receiving treatment in outpatient settings. Healthcare providers are facing emerging challenges to empower patients coping with the impacts of chemotherapy by themselves. An innovative nurse-led care program is proposed here to address this challenge. Aims: The aims of the study were to examine the effects of a nurse-led care program for cancer patients receiving treatment in a chemotherapy day center in terms of the patient outcomes (i.e. quality of life (QOL), self-efficacy, symptoms, and experience), the healthcare institution outcomes (i.e. satisfaction with care and healthcare utilization), and the impacts on the intervention nurses. Methods: The study was a single-center, open label, randomized controlled trial (RCT) which was conducted in the chemotherapy day center in an acute hospital in Hong Kong. The subjects were patients with primary breast cancer who were receiving adjuvant chemotherapy for the first time. The subjects were first assigned into two groups (i.e. group A having 4-cycle chemotherapy, and group B having 6-cycle chemotherapy). Then the subjects were allocated randomly to either the intervention arm or the control arm in each group. The subjects in the control arms received the routine care provided in the hospital. Those in the intervention arms received both the nurse-led care and the routine care. The nurse-led care program consisted of a pre-chemotherapy nurse consultation and telephone follow-up sessions during chemotherapy. These were developed by the researcher and delivered by three intervention nurses according to four evidence-based practice protocols. Both quantitative and qualitative approaches were adopted to evaluate the outcomes. The QOL and self-efficacy were evaluated by questionnaires at three time-points: before randomization (T0), in the middle of chemotherapy (T1), and one month after the completion of chemotherapy (T2). The symptom frequency and distress levels were evaluated by questionnaires in the middle of chemotherapy (T1) and one month after completion (T2). Satisfaction with the care was assessed by questionnaires at T2. The healthcare utilization during the whole chemotherapy was recorded, including patient-initiated hotline calls, clinical visits, clinical admission, emergency room visits, and emergency admission. The experiences of the subjects in the intervention arms and the intervention nurses were explored by individual interviews. The QOL differences between the intervention arm and the control arm in each group were compared using repeated measures ANOVA. The differences between the two arms in each group in self-efficacy and distress levels relating to the symptoms were compared using the Mann-Whitney U test. The frequencies of the symptoms of the two arms in each group were compared using the Chi-square test. The QOL and self-efficacy changes over time within each arm were analyzed using the Friedman test. A post-hoc test was conducted when the statistical significance was identified. The interview data collected from the subjects and intervention nurses were analyzed using a qualitative content analysis method. Results: There were 125 subjects recruited for the study. Sixty were in group A (intervention: 30 vs. control: 30), and 65 in group B (intervention: 30 vs. control: 35). The subjects in group A were patients with stages I or II breast cancer. The subjects in group B were patients with stages II or III breast cancer. The mean age was 49.79 years in group A and 52.37 years in group B. The health conditions of most subjects (68.3%-74.2%) in the two groups were good before the cancer diagnosis. No statistical differences in QOL were found between the intervention arm and the control arm over time in either group. However, changes over time were noted in some domains of the QOL. In group A, the subjects in the control arm experienced deterioration over time in physical, social, and functional well-being and the overall QOL, while the subjects in the intervention arm experienced deterioration over time in physical well-being only. The mean differences in the overall QOL and the four domains between T2 and T0 of the two arms were similar. In group B, the physical well-being of both arms deteriorated significantly over time. The emotional well-being of the intervention arm improved clinically. The mean differences between T2 and T0 for the overall QOL and the functional well-being were statistically smaller in the control arm. No statistical differences in self-efficacy were found between the two arms in either group. However, changes over time were observed in both groups. In group A, the baseline physiological efficacy and the total self-efficacy were statistically lower in the intervention arm than in the control arm. This difference disappeared at T2. In group B, statistically significant improvements in the total self-efficacy and physiological efficacy over time were found in the control arm but not in the intervention arm. Of 20 chemotherapy related symptoms, significant differences between the two arms were found in the frequencies and distress levels of a few symptoms in group A. The frequencies of peripheral neuropathy (T1) and shortness of breath (T2) were lower in the intervention arm than in the control arm, and the distress level associated with fatigue (T2) was lower in the intervention arm, while the distress level of headache (T1) was lower in the control arm. In group B, no significant differences were found in the frequencies and distress levels of the 20 symptoms between the two arms. In terms of satisfaction with the care, the overall satisfaction with the care, satisfaction with the pre-chemotherapy sessions, and satisfaction with the telephone services were all significantly higher in the intervention arm than in the control arm for both groups. The nurse-led care provided opportunities to communicate and raise concerns. The subjects obtained useful information about side-effects and care strategies. These items were the ones with which the patients were the most satisfied. They were also satisfied with the psychological support provided by the intervention nurses. Their confidence improved accordingly. Regarding healthcare utilization, there were no statistically significant differences between the two arms, in either group, in the average frequency of healthcare utilization. In group A, the total frequencies of the five types of healthcare utilization of the two arms were the same (31 times), and the total numbers of hospital days tended to be fewer in the intervention arm than in the control arm (control: 34 vs. intervention: 30). In group B, both the total frequencies of the five types of healthcare utilization (control: 61 vs. intervention: 36) and the total numbers of hospital days (control: 70 vs. intervention: 39) tended to be fewer in the intervention arm than in the control arm. Ten subjects in the intervention arms and the three intervention nurses were interviewed individually. Some subjects finished chemotherapy smoothly, while the others encountered obstacles. Guided by their coping attitudes (i.e. facing the challenge bravely and trying their best) which were influenced by Chinese culture, most subjects adopted behavioral, social, cognitive, and emotional strategies to cope with the chemotherapy actively. The subjects thought that the nurse-led care provided useful information and psychological support, filled the service gap after drug infusion, relieved discomfort, and built up their confidence. Delivering the nurse-led care brought benefits to the intervention nurses as well. During the interactions with the subjects, the intervention nurses had chances to apply their experiences into practice. Their professional knowledge and communication skill were enhanced. The awareness of evidence-based practice was developed. The positive changes in the subjects improved their job satisfaction. The interactions between the intervention nurses and the subjects caused mutual benefits. Conclusions: This study has provided encouraging evidence about the effects of the nurse-led care for cancer patients receiving chemotherapy in outpatient settings. The nurse-led care improved the patients' satisfaction with the care and might have reduced their healthcare utilization. Although the nurse-led care may not have had an impact on breast cancer patients receiving adjuvant chemotherapy in terms of their QOL, self-efficacy, and most of their symptoms, it did benefit them in other ways. The nurse-led care is a reliable information source for patients and a "safety net" during chemotherapy. It improved their confidence and relieved discomfort for some patients. Some also benefited from the psychological support provided by the intervention nurses. The nurse-led care program is suitable to implement with breast cancer patients and is feasible to apply in other chemotherapy day centers in Hong Kong. The nurse-led care should be delivered proactively so as to address the needs of Chinese patients. More research is needed in future in six directions: (i) more RCTs to test the effectiveness of the nurse-led care with larger sample sizes, (ii) research to explore innovative methods to encourage and monitor patients{174} behavioral changes in individualized care, (iii) research on interventions for single symptoms and symptom clusters, (iv) research on self-efficacy and confidence in Chinese cancer patients, and (v) research on the need for supportive care in relation to sexuality and intimate relationships of cancer patients in Hong Kong.