Abstract
Background/Aim: Many cancer patients receive radiotherapy, which may cause distress. This pilot study evaluated distress levels before and after radiotherapy to contribute to the design of a prospective trial. Patients and Methods: Two-hundred patients completed distress thermometers before and after radiotherapy. Distress levels ranged from 0 (no distress) to 10 (maximum distress). Five characteristics were retrospectively analyzed regarding changes of distress including age, sex, performance score, tumor type, previous radiotherapy, and treatment intention. Additional analyses were performed for elderly (>65 years) and non-elderly (≤65 years) patients. Results: In all patients and both age groups, median pre-radiotherapy and post-radiotherapy distress levels were 5 (0-10) vs. 4 (0-10) points. Mean changes of distress levels were −0.5 (±2.6) points in all, −0.4 (±2.5) in elderly, and −0.7 (±2.8) in non-elderly patients. Changes were significantly associated with tumor type in all (p=0.049) and elderly (p=0.025) patients. Conclusion: Future studies investigating distress levels in patients receiving radiotherapy should consider age and tumor type.
Many cancer patients assigned to radiotherapy experience a high level of distress due to practical, emotional or physical problems (1). Emotional problems, mainly fears, nervousness and worry, may be aggravated due to the upcoming treatment. It is unclear whether distress levels of patients assigned to radiotherapy increase, decrease, or remained unchanged during the course of their treatment.
On one hand, radiation-related acute adverse events can lead to significant symptoms and physical or even practical problems associated with an increase of the patients’ distress levels (2). Adverse events may lead also to emotional problems, since patients may have the feeling that something is going wrong with their treatment. An impact of adverse events was previously reported for sleep disorders. In a study of breast cancer patients, adverse events of radiotherapy led to increased symptoms of insomnia (2). This is of significance insofar as in several previous studies, sleep disorders were associated with higher distress scores (3-9).
On the other hand, patients may get used to the procedure of a radiotherapy session, which they undergo five days per week for several weeks, leading to a decrease of pre-treatment distress levels. In a prospective study, the majority of patients irradiated for breast or prostate cancer reported the maximum of sleep disorders before and during the beginning of their radiotherapy course (10). Moreover, in a recent prospective observational study, improvement of sleep disorders was found in 39% of breast cancer patients at the end of their radiotherapy course when compared to pre-radiotherapy scores (11). However, no studies have so far investigated potential changes of distress levels during a course of radiotherapy. This pilot study evaluated distress scores before and after radiation treatment in 200 patients. The results of this study will be used to design a prospective trial.
Patients and Methods
A total of 200 patients receiving radiotherapy between November 2021 and April 2022 were included in this pilot study, which was approved by the ethics committee at the University of Lubeck, Germany (reference 2022-412). Characteristics of the patients are summarized in Table I. Patients were asked to complete the distress thermometer of National Comprehensive Cancer Network (1) prior to and directly after completion of their radiotherapy course. Distress levels on this thermometer ranged from 0 (no distress) to 10 (maximum distress) points. In addition, five characteristics were retrospectively analyzed regarding changes of distress during the course of radiotherapy including age (≤65 vs. >65 years), sex (female vs. male), Karnofsky performance score (50 vs. 60 vs. 70 vs. 80 vs. 90 vs. 100), primary tumor type (breast cancer vs. lung cancer vs. head-and-neck cancers vs. kidney cancer vs. gastrointestinal cancers vs. melanoma vs. cancer of unknown primary vs. prostate cancer vs. other malignancies), history of previous radiotherapy (no vs. yes), and treatment intention (curative vs. palliative) (Table I). Additional analyses were performed in the subgroups of elderly (>65 years) and non-elderly (≤65 years) patients.
Increase and decrease of distress levels were defined as a change of +2 points and −2 points, respectively. Median values (plus ranges) of pre-radiotherapy and post-radiotherapy distress scores were calculated for the entire cohort and the two age groups. In addition, the mean values (plus standard deviations) of the changes of the distress scores (post-radiotherapy score minus pre-radiotherapy score) were calculated for the entire cohort and both age groups. Statistical analyses regarding a potential impact of patient characteristics on changes of distress levels were performed with the Wilcoxon two-sample test (comparison of two groups) or Kruskal-Wallis test (comparison of more than two groups). p-Values <0.05 were considered to indicate statistical significance and p-Values ≤0.10 to indicate a trend.
Results
Of the entire cohort, 185 patients (92.5%) were evaluated for changes of distress levels. In these patients as well as in the groups of elderly (n=108) and non-elderly (n=77) patients, median pre-radiotherapy and post-radiotherapy distress levels were 5 points (range 0-10 points) and 4 points (range=0-10 points), respectively. Mean changes of distress levels were −0.5 (±2.6) points in the entire cohort, −0.4 (±2.5) in elderly patients, and −0.7 (±2.8) in non-elderly patients, respectively. Changes were significantly associated with primary tumor type in the entire cohort (Figure 1, p=0.049) and in the group of elderly patients (Figure 2, p=0.025). In addition, trends were found for sex (p=0.10) and intention of treatment (p=0.085) in non-elderly patients. The changes of all investigated characteristics in the entire cohort and both age groups are summarized in Table II, Table III and Table IV.
Discussion
Being assigned to radiotherapy can lead to significant emotional distress. In a previous study of breast cancer patients irradiated after breast conserving surgery, approximately half of the patients reported distress due to the upcoming course of radiotherapy (12). In another study of patients irradiated for breast cancer, emotional distress was negatively associated with the patients’ quality of life (13). Thus, distress is an important endpoint in the context of cancer treatment such as radiotherapy. However, it is not clear whether the level of distress changes during a course of radiotherapy, since there is a lack of studies addressing this question. Therefore, this pilot study was performed that compared distress scores before and directly after radiotherapy. Its major goal was to provide data that can be used to design a future prospective trial.
According to the results of this pilot study, changes of distress levels were significantly different between the various primary tumor types. This likely reflects the different prognoses of the tumor types, and maybe the different personalities of the corresponding patients. For example, lung cancer is more common in heavy smokers, and head-and-neck cancers in alcoholics. Therefore, the type of primary tumor should be strongly considered in future prospective trials, e.g. to allow for optimal stratification.
In addition, subgroups analyses in elderly and non-elderly patients were performed. The mean changes of the distress levels were slightly different between both age groups. However, when looking at the associations between investigated characteristics and changes of distress levels, important differences were found between both groups. In elderly patients, changes were significantly associated with type of primary tumor, and in non-elderly patients trends were found for sex and intention of treatment. These differences show that it is important to differentiate between elderly and non-elderly patients in future trials.
These findings are supported by results of a study of 148 cancer patients from Saudi-Arabia undergoing radiotherapy (14). Younger age was a significant predictor of psychological distress and social concerns (p<0.05). Moreover, previous studies of breast cancer patients have shown associations between age and distress. In a study that investigated risk factors for emotional distress prior to radiotherapy, younger age showed significant associations with increased emotional distress in terms of fears, sadness, and worry (15). In the study of Mose et al., distress levels were high in women aged ≤58 years (12). In four other studies and a systematic review of breast cancer patients, younger age was also significantly associated with higher distress levels (16-20). Moreover, in two studies investigating the prevalence and risk factors of pre-radiotherapy sleep disorders in patients with breast cancer or head-and-neck cancers, a higher prevalence was significantly associated with younger age (3, 21). Sleep disorders were found to be associated with higher distress scores and may, therefore, be considered a consequence of distress (3-9). Despite the agreement of our findings with the results of previous studies, one should be aware of the retrospective nature during its interpretation. However, the results of this pilot study are important and will be considered for the design of a future prospective trial investigating changes of distress levels in cancer patients during their course of radiotherapy.
Conclusion
This study identified significant differences between various primary tumor types with respect to changes of distress levels during a course of radiotherapy. Moreover, differences regarding distress scores were found between elderly and non-elderly patients. These findings demonstrate that it is reasonable to perform separate studies for different age groups and for different primary tumor sites. Thus, future trials investigating distress levels in patients receiving radiotherapy should consider both primary tumor type and age.
Acknowledgements
The study was funded by the European Regional Development Fund through the Interreg Deutschland-Danmark program as part of the project TreaT (148-1.1-21).
Footnotes
Authors’ Contributions
C.D., S.J., D.K., S.T., S.E.S. and D.R. participated in the design of the study. C.D. provided the data, which were analyzed by a professional statistician supported by D.R. The article, drafted by C.D., D.R. and S.E.S., was reviewed and approved by all Authors.
Conflicts of Interest
On behalf of all Authors, the corresponding Author states that there are no conflicts of interest related to this study.
- Received August 16, 2022.
- Revision received August 31, 2022.
- Accepted September 2, 2022.
- Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.
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