Abstract
Pain in cancer is often underdiagnosed and undertreated. Breakthrough pain, in particular, severely impacts the quality of life of patients. In this study, we evaluated management and care of pain in Spain from the patient perspective by assessing the experience of 275 patients who had suffered breakthrough pain. Although most patients had suffered moderate-to-severe pain in the last 24 hours, pain relief was achieved in the majority of cases. The body areas with a higher pain intensity was felt varied based on primary cancer. Adherence to treatment was subpar, and patients were moderately concerned about addiction to treatment and adverse events. Doctors did not assess pain in every visit and there is room for improvement in its classification. Education strategies directed toward patients and health care personnel are needed to improve pain assessment, follow-up, and compliance. These could guide shared decision-making and improve communication about cancer pain to improve its care.
Introduction
Pain is a major source of distress associated with cancer and it significantly impacts patients’ quality of life, diagnosis and treatment (1). Although its prevalence varies between studies, it has been estimated that 55% of cancer patients undergoing treatment feel pain (2). Pain can be classified in multiple ways by evaluating domains such as location, intensity, temporal pattern, pathophysiology, and etiology (3,4). However, not all domains are evaluated in all cases, nor are other relevant aspects, such as characteristics of the disease (primary diagnosis, extent of the disease, metastasis), demographics, and psychological status (3).
In order to provide an adequate and personalized treatment of pain, it must be properly assessed and understood. One major type is breakthrough cancer pain (BTP), which is a “transitory exacerbation of pain that occurs, either spontaneously or associated with predictable factors or not, even though the baseline pain is relatively stable and well controlled” (5). The definition of BTP is still a source of debate, and there is variability on what constitute its minimum intensity, duration, and number of flares (6 –8). Additionally, not all clinicians consider opioids should be used to control this pain (6). The pathophysiology of BTP is heterogeneous, but the 2 main subtypes are incident pain (either voluntary, involuntary or intervention-related) and spontaneous pain (which is unpredictable) (9). The prevalence of BTP varies between studies (10), but its presence is associated with higher pain intensity, functional impairment, and a significant impact on quality of life (11,12). High prevalence rates of BTP in cancer patients were found in 2 recent studies in Spain, one of which notably showed that these high rates were not expected by doctors (13,14).
Although management of cancer pain has improved in recent years, it is still an ongoing challenge, with clinician and patient barriers—among others—that need to be overcome (15). A third of patients are found to be undertreated for pain (16). On this note, a study of 12 countries, not including Spain, found that 12% of patients reported health care professionals did not regard pain as a problem, and 50% perceived clinicians did not consider their quality of life to be important (17).
The Spanish Foundation for Excellence and Quality in Oncology (Fundación ECO) is committed to improving care of cancer patients. To this end, Fundación ECO directed this patient-centered study to understand their experience and unmet needs regarding pain. The aim of this article is to present the findings of the surveys carried out on pain (including BTP), the care received, the degree to which pain management was achieved, and the impact on quality of life as well as to discuss strategies to address the identified needs.
Methods
Study Design
This was a cross-sectional, multicenter, study. To calculate the sample size needed, we considered a margin of error of 6%, a 95% level of confidence, and a response distribution of 50%. This resulted in a required sample size of 275 patients. To guarantee this number was achieved in the event of possible withdrawals, 47 oncologists were invited to participate, their number being proportional to the population of their respective regions. Each oncologist recruited 4 to 6 patients until the required sample size of 275 was reached. From the study starting date, for 4 to 6 consecutive days, the first eligible patient of each day was asked to participate in this study. All patients provided written informed consent. Inclusion criteria were patients who were: over 18 years old; suffering from pain associated with cancer, including BTP; and, if taking analgesics, having initiated treatment at least 1 month prior to inclusion in this study. The only exclusion criterion was the patient’s lack of consent to participate.
An ad hoc questionnaire was provided to oncologic patients to assess pain associated with cancer, including BTP. Each oncologist collected the anonymized questionnaires and, once the last one was received, patient data were aggregated and recorded in a restricted-access online repository platform designed for this study. There was no patient follow-up after the questionnaire was submitted.
Due to the nature of the study, submission to the Spanish Agency of Medicines and Medical Products was not required. Nevertheless, this study was performed in accordance with the Declaration of Helsinki and submitted to the clinical research ethics committee, who issued a favorable opinion.
Variables Studied
Descriptive patient variables were recorded: demographics (age, sex, level of education, autonomous region of Spain) and clinical variables (type of cancer, pain associated with cancer [type, intensity, location, and progression], and impact on quality of life). Descriptive patient opinion variables were also recorded: attitude toward pain on the part of the oncologist and other health care professionals, quality of information received regarding pain and possible treatment, pain follow-up, adherence to recommended treatments, degree of personalization received, and general satisfaction with care compared with the patient’s expectations.
Data Analysis
Continuous variables were described using means ± SD, using medians and ranges in cases of large dispersion of data. Categorical variables were described using frequencies and CIs. Continuous variables were compared using independent t tests or Mann–Whitney U tests, as appropriate. All statistical analyses were carried out with SPSS version 21.0 (IBM Corp)
Results
Oncologist Profile
A total of 47 oncologists participated in this study (27 women, 20 men), with an average age of 38.9 (95% CI: 36.8-41.0) years and a median age of 38 (range, 30-55). No significant difference in age was found between women (39.0 years) and men (38.7 years; P = .094). Professional experience ranged from 2 to 28 years, with an average of 11.9 (95% CI: 10.1-13.7) and a median of 10 years. There was no significant difference in work experience between women (12.1 years) and men (11.7 years; P = .650). Most oncologists (46, 97.9%) worked in the public health care system, 3 of them in combination with private practice; only 1 oncologist worked exclusively in a private hospital. Oncologists saw an average of 20.4 (95% CI: 12-25) patients per day, with 30.5% of them reporting BTP.
Patient Demographics
A total of 275 patients representing 11 of the 17 autonomous regions of Spain were included in this study (Table 1). The average age was 62.4 (95% CI: 61.0-63.7) years and ranged from 19 to 86. Of these, 46.5% were women. Regarding education level, 14.2% had no studies, 36.0% had primary level studies, and 16.0% had a university degree. The most common primary tumor was lung (77, 28.0%), followed by breast (42, 15.3%) and colorectal (36, 13.1%).
Patient Characteristics.
a No pain at the time the patient was included in the study, other than common headaches, toothaches, contusions, and so on.
At the time of inclusion in the study, a considerable number of patients (250, 90.9%) felt pain. Most patients (190, 69%) reported feeling both chronic pain and BTP throughout the disease, while 38 (13.8%) and 47 (17.1%) felt only either BTP or chronic pain, respectively.
Pain Description
Patients reported the specific body area where they felt the most severe pain. Among all cancer types, the most common areas for pain were the abdomen (22.5%), torso (9.8%), neck (6.6%), spine (6.2%), and hips (5.8%) (Table 2). The most affected areas differed based on the primary cancer, with lung cancer patients feeling most pain in the spine (13%) and the lumbar area (11.7%), breast cancer patients feeling most pain in the lumbar area (23.8%) and the hips (19.1%), and colorectal cancer patients feeling most pain in the abdomen (66.7%).
Pain Location by Cancer Type.
Patients reported the minimum, average, and maximum pain they had felt in the previous 24 hours on a scale from 0 (lowest) to 10 (highest; Figure 1). Almost half (127, 46.2%) of patients reported a maximum pain of ≥8. Almost 70% of patients (192, 69.8%) felt an average pain between 3 and 6, and also a minimum pain under 3 (195, 70.1%).
Pain severity in the last 24 hours.
Patients reported feeling pain for an average of 10.3 (95% CI: 8.8-11.8) months and a median of 6 (range, 0.5-84) months. The average time patients had experienced BTP was 6.5 (95% CI: 5.1-7.6) months, with a median of 3 months (range, 0.3-6). Only 3 patients reported feeling no BTP.
When questioned about the cause of pain, 179 (65.1%) patients believed their pain was related only to the cancer, and 63 (22.9%) attributed it to both the cancer and the cancer treatment. Only 22 (8%) patients believed their pain was caused by the cancer treatment alone, and the remaining 11 (4%) patients attributed their pain to other causes or did not respond.
Impact of Pain on Patient Quality of Life
Patients reported the degree to which pain had affected their life, on a scale from 0 (not affected) to 10 (severely affected), in the following: general activity, mood, walking, work, relationships, sleep, and life enjoyment. The domains most affected were life enjoyment (average score, 6.34), general activity (6.31), and mood (6.2). Lower average scores were given to impact on work (6.03), relationships (5.03), and sleep (5.47), with the lowest score being for walking (4.98).
Care received for Pain
Most (213, 77.5%) patients reported being informed at diagnosis of the possibility of feeling pain associated with cancer, 31 (11.3%) patients reported not receiving this information, and another 31 (11.3%) did not remember. Most (227, 82.5%) patients also reported their oncologist informed them that pain can be controlled, while 24 (8.7%) patients said they were not informed of this, and another 24 (8.7%) did not remember.
Regarding monetarization of pain, 197 (72.9%) patients reported their doctor asked about it on every visit, 52 (19.3%) said it happened in most visits, 7 (2.6%) reported they were asked about it in less than half the visits, and 14 (5.2%) reported only occasionally being asked about pain. No patient reported not having been asked. Pain discussion was most commonly initiated by doctors (41.7%) than by patients (25.4%). Only in 16.9% of cases did the doctor ask about pain intensity; in 10.8% of total cases, the doctor examined the patient.
Oncologists were the main health care professionals (65%) involved in treating pain associated with cancer, followed by primary care doctors (11.0%), palliative care doctors (5.1%), anesthetists or pain unit doctors (4.9%), and radiation oncologists (4.6%).
Perspectives on Pain Relief Medication
Satisfaction with pain relief treatment was high, with 113 (43.1%) patients reporting being very satisfied and 133 (50.8%) being quite satisfied. Addiction to treatment was a cause for concern in almost half of patients, who were either very worried (38, 13.8%) or quite worried (80, 29.1%) about it. Additionally, over half of patients were either very worried (36, 13.1%) or quite worried (110, 40.0%) about the adverse events of pain relief treatment.
Questions about adherence to pain relief treatment showed that 46 (16.7%) patients sometimes forgot to take the medication, 48 (17.5%) did not take it at the indicated time, 87 (31.6%) stopped taking it once they felt better, and 142 (51.6%) stopped taking it if it did not agree with them. However, regarding treatment for BTP, almost all (264, 96%) patients followed treatment guidelines.
Regarding chronic pain management in the 24 hours prior to the patients’ visit, 191 (69.5%) patients reported relief over 70%. Eight (2.9%) patients experienced no or minimal relief, under 20%. In the case of BTP, 204 (74.2%) patients reported relief over 70%, and 7 (2.5%) patients experienced no or minimal relief, under 20%.
When asked about their degree of satisfaction with pain relief treatment, only a small percentage of patients reported being quite or very unsatisfied with the effectiveness of treatment (36, 13.1%), tolerance of adverse effects (43, 15.6%), and overall treatment (34, 12.4%).
Discussion
In this study, we evaluated the pain care that cancer patients receive in Spain from a patient-centered perspective. We found that most patients had suffered moderate-to-severe pain in the last 24 hours and had suffered from pain for an average of 10.3 months. We assessed the impact of pain on quality of life, adherence to treatment, and doctor attitudes to understand the different aspects involved in pain management.
A systematic review found the average prevalence of BTP was 61.0%, although there was high variability between studies, ranging 33.3% to 95.0%, with higher rates corresponding to patients in hospice (10). A recent study in Spain found that 91.3% of cancer patients with pain had suffered from BTP, although almost half of them had been undetected by doctors (13.) Our study did not address prevalence of BTP, as one of our inclusion criteria was that patients had suffered BTP at some point, although 3 of them later reported in the questionnaire that they had not experienced it.
The body areas where patients felt most pain varied depending on the primary cancer, in agreement with reports by others (18). Overall pain prevalence has also been found to vary based on primary cancer (14,17); however, we did not evaluate this due to the data being aggregated.
In contrast to the finding that pain is undertreated in approximately a third of cancer patients (16), most patients (93.9%) in our study were satisfied with the pain relief achieved with medication. This finding is also higher than a previous study in Spain, reporting that almost half of patients with BTP did not achieve pain control (14). While we observed that 96% of patients adhered to treatment for BTP, adherence to chronic pain treatment was subpar, with 1 in 6 patients forgetting to take the medication. The main patient barrier to adherence was negative side effects, with over half of patients not taking the medication for this reason. Patient education has proven to improve quality of life and adherence to treatment for cancer pain (19 –21) and to decrease pain intensity (19 –23). Future work in Spain could focus on carrying out patient education strategies using several methods (21): face-to-face coaching sessions, follow-up phone calls, and informational videos, among others. These initiatives could target patient compliance and educate on opioid treatment, its associated adverse events, and addiction, as these were a cause for concern for approximately half of patients in our study, which is in agreement with reports from other countries (24 –27).
Education of all health care personnel should also be considered, given that, in 35% of cases, patients reported that pain was not followed by an oncologist. Patients also reported the doctors examined them in only 10.8% of cases and assessed pain intensity in 16.9% of cases. On this note, oncologists in this study saw an average of 20.4 patients per day, a third of them reporting BTP, and a recent Delphi survey found that Spanish oncologists considered limited time to evaluate patients to be a barrier to managing BTP (28). Classifying pain in all of its domains can provide more information and improve understanding of patient needs to, ultimately, deliver a higher quality of pain care. Studies have shown that physicians consider there are deficiencies in pain management training (29 –31). On this note, a study in Spain found that almost half of oncologists had not read the guidelines on diagnosis and treatment of BTP (13). This further highlights the need to not only educate patients but also health care professionals. Additionally, significant differences were found on nurses’ training on pain management across 12 European countries (32). Initiatives to improve pain management by health care professionals could include mandatory palliative care rotations for trainees, developing multidisciplinary teams, creating educational courses, and encouraging interdisciplinary work (33). Most patients desire shared decision-making in pain management (34), which leads to more open communication and higher patient satisfaction (35).
This study provides, for the first time, the patient perspective on management of pain associated with cancer in Spain. We believe our findings can be useful for health care professionals and decision makers to better understand and address patient needs. They can also serve as a basis for implementing policies that address the issues found, such as the need for evaluating pain in several ways, most notably examining the patient and grading pain intensity. We suggest placing a stronger focus on education of patients and health care professionals, and implementing strategies that encourage open communication about pain.
Limitations
The main limitation of this study is the use of aggregated data of patient reports, which precludes establishing associations between the parameters evaluated. For example, studying the association between type of primary cancer and pain intensity, or that between information provided by the doctor and adherence to treatment could help develop guidelines and strategies toward personalization of pain care. Also, our sample size is relatively small, with a predominance of 3 cancer types (lung, breast, and colorectal). Future studies that address these limitations could further establish links between the parameters evaluated here and improve pain management. Finally, this study reports the experience of patients and their opinions; however, we cannot confirm the information they report, and we cannot rule out a possible bias in their expectations of care.
Conclusion
We evaluated the perspective of cancer patients in Spain regarding care of pain and found that, although almost half of them had felt a very high maximum pain in the previous 24 hours, the vast majority were satisfied with the degree of pain management achieved with analgesics. The body areas where patients felt most pain were the abdomen, torso, neck, spine, and hips, predominance varying with primary cancer type. The dimension of quality of life that patients considered were more affected by pain was life enjoyment and general activity. Our findings highlight some areas of improvement in pain management and could guide strategies that address them.
Footnotes
Authors' Note
This study was performed in accordance with the Declaration of Helsinki and submitted to the Clinical Research Ethics Committee at the San Carlos Clinical Hospital in Madrid (Spain), who issued a favorable opinion.
Acknowledgments
The authors thank all doctors and patients that participated in this study. The authors also thank Angela Rynne Vidal, PhD, for providing writing and editing support, funded by Fundación ECO.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by Kyowa Kirin.
