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The purpose of this study was to gain a better understanding of how opioid-induced constipation (OIC) influences pain management and quality of life in patients with cancer near the end of life. This was a descriptive study consisting of a national sample of HPNA members (n = 502) working with hospice or palliative care patients, cancer patients (n = 109) who were hospice eligible or with end-stage disease, and informal caregivers (n = 200) of cancer patients. Parallel survey instruments were developed and sent via the Internet to all three groups. Data were analyzed using frequencies, percentages, means, and SDs. Results demonstrate that patients, family caregivers, and nurses all recognize the significance of OIC and its negative impact on both patients and families, and all three groups appreciate the importance of successful management of this distressing symptom.
Constipation is a common problem among patients receiving opioids, particularly in those diagnosed with cancer as the cancer advances and they approach the end of their lives. Further, constipation is known to cause some degree of symptom distress and to have a negative impact on the patient's quality of life.1-6 The exact incidence of constipation is not known, but in oncology populations, it is estimated to range between 50% and 95%, with the highest incidence occurring in patients receiving opioids.5 Although it is very amenable to intervention, constipation often goes unrecognized and untreated in many settings.6 A study of hospice patients with cancer found that even after 2 weeks of hospice care, 68% of patients still reported problems with constipation.3
Opioids are among the most common types of drugs used to treat cancer-related pain as well as other distressing symptoms such as dyspnea that may occur in life-limiting illnesses.7,8 It is well established that opioids cause constipation because of their effect on the bowel that includes slowing of peristalsis and a decreased urge to defecate.7,9-11 In fact, because of this effect on the bowel, opioids were used for the treatment of diarrhea long before they were used for analgesia.12 Studies that show a relationship between pain management and constipation support this finding. A series of studies conducted in hospice patients with cancer beginning in 1994 have reported constipation in 64% to 80% of these samples.3,13-17 Quality of life becomes the paramount concern during palliative care or during end-of-life care. Previous research had shown that constipation can create symptom distress and have a negative impact on overall quality of life. For example, in a study including 178 hospice patients with cancer,3 a stronger negative relationship was found between constipation and quality of life (r = -0.38; P = .000) than between pain and quality of life (r = -0.20; P = .01).3
Very little research has been conducted focusing on the prevalence and trajectory of this constipation. A significant problem facing healthcare providers with regard to treating opioid-induced constipation (OIC) is the lack of research on which to base treatment decisions.
A team of clinical and research experts was assembled by the Oncology Nursing Society to review the current research related to the management of constipation in persons with cancer to develop evidence-based guidelines. This intensive review was conducted between June and December 2006. The results showed few intervention studies including cancer patients with opioid-induced or other types of constipation. Further, this expert group concluded that despite the frequent occurrence of constipation in oncology populations, only limited research has been conducted by a small handful of investigators.18-25 Thus, little definitive evidence is available to guide the practice of healthcare practitioners who must help patients manage this problem. As a result of its review, the Oncology Nursing Society group of experts called for future research focusing on this constipation that is known to have a negative impact on the quality of life of persons with cancer.5 The purpose of this project was to gain a better understanding of how OIC influences pain management and quality of life in patients near the end of life.
A three-part sample was drawn for this study. Hospice and palliative care nurses were identified from the membership of the HPNA. End-stage cancer patients were drawn from a national database, as was an independent group of family caregivers. Patients and caregivers had voluntarily registered to participate in research studies. It should be noted that while it might be possible for individuals in the three groups to have been related, there was no plan or design that the caregivers or nurses were matched in any way to the patients in the sample. Each was considered an independent sample; thus, comparisons between groups may not be meaningful.
A sample of 109 cancer patients was surveyed during March and April 2007. Inclusion criteria were a cancer diagnosis, advanced stage of disease, functional status reported as 40 to 100 on Karnofsky Performance Status scale, currently receiving or recommended for hospice or palliative care or hospice eligible, taking regular doses of opioids, and having experienced OIC at some point. The patient sample was divided between hospice-eligible and end-stage groups, with the hospice-eligible patients being the more severely ill.
A sample of 200 family caregivers was surveyed during March and April 2007. To be included, caregivers had to be providing care for someone diagnosed with advanced cancer who met the inclusion criteria for the patients in the study. Thus, caregivers were surveyed who were providing care to hospice-eligible patients.
A sample of 502 nurses was drawn from the membership of HPNA and surveyed during March and April 2007. To be included, the nurses had to be RNs or advanced practice nurses (APNs), had to be currently practicing in hospice or palliative care settings, and have a population of patients that included at least 25% who had been given a terminal diagnosis and a prognosis of less than 6 months and a population of patients that included at least 25% who were taking regular doses of opioids for pain or management of other symptoms.
A multipart survey instrument was developed by StrategyOne in collaboration with HPNA. The survey was developed for use online and took approximately 20 to 25 minutes for each type of respondent to complete. A set of questions was directed at the patients, a parallel set to the caregivers, and a different but related set to the nurses. Questions included demographic and disease-related data, end-of-life priorities, management of pain and other symptoms, the importance of opioids in managing pain, and information about OIC. Constipation questions included those about how much of a problem OIC was, adverse effects, OIC's effect on life priorities and activities, treatments used for OIC, and effectiveness of those treatments.
Data were entered into SPSS (SPSS, Chicago, IL) for analysis. Data were analyzed using means, SDs, frequencies, and percentages and were tabled by respondent group.
Demographic data describing patients as reported by the caregivers (for their patients) and by the patients (about themselves) are summarized in Table 1. The most common cancers in both groups were lung, followed by breast in the patient group and pancreatic in the caregiver group. More than half of patients in both groups were older than 50 years. In the patient group, most patients (66%) were female, while in the caregiver group, there were slightly more male (53%) than there were female patients. The performance status scores (Karnofsky) were higher in the patients reported on by the caregivers than in the patient group that self-reported. In both groups, most patients were receiving care in their own homes. In more than half of cases (51%), the caregiver was the spouse, as reported by the patients. In the patient group, 32% reported caring for themselves (Table 1).
Caregivers were asked to provide demographic data not only to describe their own patients, but also to describe themselves (Table 1). The mean age of the caregivers was 46.1 years, with a range from 21 to 79 years. Although there were much missing data of the caregivers who reported, most were female and appeared to be representative of the various regions of the United States.
Nurses were asked for demographic data to describe themselves and to ensure that they fit the study criteria. Most nurses (57%) indicated that they were older than 50 years and female (95%). Most lived in the United States and worked as RNs in a variety of settings where patients receive hospice and palliative care. The majority (65%) had worked in palliative or hospice care for less than 10 years (Table 2). The majority (85%) indicated that most of their patients had been told that they would survive 6 months or less. Nurses also were asked what percentage of their patients received opioids for symptoms other than pain, and the responses were split, with the largest percentage indicating that between 25% and 74% of patients did.
Both patients and caregivers were asked which symptoms of their disease posed the greatest challenge to maintaining their overall patient quality of life. In both groups, fatigue was first, followed by pain. Constipation was named by 22% in the patient group and 25% in the caregiver group. About pain, a majority of both patients (82%) and caregivers (93%) reported that the patients have pain at some time. Most in both groups reported patients as having pain daily (Table 3). Only a minority of hospice-eligible patients and end-stage patients reported being somewhat or very dissatisfied with current pain control. Both patients and nurses agreed with statements that opioids are essential to pain relief and to improving quality of life, with slightly higher percentages being reported by the nurses.
Constipation was reported, by far, to be an adverse effect of opioids that was most frustrating for patients (Table 4). Both patients and caregivers reported changing opioids or doses because of OIC, with the largest numbers reporting that the dose of opioid was reduced (Table 5). A sizable majority of patients (80%), caregivers (88%), and nurses (95%) agreed that pain would be easier to manage if the effects of OIC could be better controlled. Patients and caregivers were asked about the numbers of episodes of OIC the patient had experienced. Approximately half of each group reported more than five episodes. When asked how problematic OIC has been for the patients, both patients and caregivers tended to put it in the "very" to "somewhat problematic" categories.
Nurses were asked a series of questions about how OIC affects patient care and quality of life. A large majority agreed that OIC diminishes quality of life and makes it difficult to provide good care and agreed that resolving OIC helps patients to focus on more important things in life.
Nurses were asked to estimate about how much time they spend each day taking care of their patients' OIC. Their responses indicated that OIC takes a lot of nursing time each day, with assessment for OIC and evaluating success of treatment taking the most (Table 6).
Patients were asked to report on the challenges that OIC creates in patients meeting their priorities. At the top of the list as challenges were staying active and engaged (59%), staying in control (48%), and reducing pain (45%) (Table 7).
Caregivers were asked to report the impact that managing OIC in the patients had on their own lives. At the top of the list of problems were finding time to going to work and socializing with friends.
Nurses were asked about having conversations with patients about OIC. Nurses reported that patients were reluctant (85%) and embarrassed (84%) to discuss their challenges with OIC. Among the patients, 58% indicated that they were reluctant to discuss OIC with family members, and 41% of patients and 47% of caregivers agreed that they do not know where to turn for advice about OIC. Most nurses (86%) reported that it is the nurse who must initiate the conversation with the patient about OIC.
Finally, nurses were asked to report activities that patients could do once their OIC was resolved. At the top of the list were eating food they enjoy (77%), getting proper nutrition (58%), sleeping (54%), spending time with family and friends (51%), and participating in social events and activities (50%) (Table 8).
The four most common cancers in the patient sample mirror the most common cancers seen in the US. The most common is breast cancer and the second is lung cancer, the biggest cancer killer in the United States.26 A higher percentage of the caregivers (versus patients) reported providing care for lung cancer patients; this difference in numbers might have occurred because patients with lung cancer were more likely to be debilitated and thus less likely to be able to self-report. In addition, most patients were 50 years or older, which also is consistent with the US cancer statistics. More of the patients in the patient-reporting group were female, while more patients in the caregiver-reporting group were male, indicating that most respondents were females. Earlier research with end-stage cancer patients in hospice care has shown that the patients are more likely to be male and caregivers more likely to be female.16 Although very few of the patients were functioning at a normal level (Karnofsky = 100), relatively few were at the lower level of 40 or 50. Most were reported to be between 60 and 80, with the patient group reporting itself to be at a somewhat higher level of functioning. This latter result is probably due to the self-report feature of the data; patients had to be healthy enough to sit at the computer and answer questions for 20 to 25 minutes to participate in the survey. Patients who were less able to participate in the survey were more likely to need caregivers.
As might be expected, most patients were reported by both patients and caregivers to be residing in their own homes. This seems consistent with their reported functional status; higher-functioning patients are more likely to remain in the home. For those patients with caregivers, the largest number (51%) were reported to be spouses. It is unclear what patients meant by indicating that the physician was the caregiver; perhaps the patients who had no caregiver did not understand the intent of the questions, which was asking about informal or family caregivers, not healthcare providers.
The patients reported their caregivers to be more likely to be female and their patients to be male (Table 1). This finding is consistent with earlier studies16 and probably occurred because the caregiver role in our culture is more often taken by a woman, if one is available to serve. The mean age of the caregivers was within middle age (Table 1), but the age range was wide, probably reflecting the older spouses who were caregivers as well as the younger generation of children and grandchildren who also took this family responsibility. The caregiver group represented all areas of the country, which helps to make the sample more generalizable.
The nurses' ages were well distributed, with most (57%) being older than 50 years (Table 2). However, this relatively advanced age did not translate into more years of experience in the hospice or palliative care field. The majority (65%) had been in the field for less than 10 years, with 31% reporting less than 5 years in hospice or palliative care. This is most likely the result of the recent rapid growth of hospice care in the US and the increasing acceptance of palliative care as an essential part of healthcare, which increased the number of job openings for nurses. Only 15% were APNs or nurse practitioners; the majority were RNs. This is not surprising, given that there are many more RNs in the US than APNs. More than 99% of the nurses reported working in the US, making these data less generalizable in other parts of the world where healthcare systems may differ dramatically from the US.
The nurses were asked about their populations of patients. Most patients receiving care from the nurses in the sample were receiving home care. This might have included patients receiving hospice home care or care from a community health agency, or it might have meant outpatient care in a local clinic because this latter category was not specifically included in the survey (Table 2). The largest group of nurses (85%) indicated that between 75% and 100% of patients had been given a prognosis of 6 months or less, making them hospice eligible. And because the focus of the study was OIC, the nurses were asked what percentage of their patients received regular doses of opioids for pain relief and for relief of other symptoms (Table 9). The majority (91%) indicated that more than 50% of patients received opioids for pain, an expected finding. However, smaller percentages reported patients receiving opioids for symptoms other than pain. It is well known that opioids may be used for dyspnea, for example, but this may not be the standard practice in all settings such as nursing homes. Wherever opioids are given, and for whatever purpose they may be given, they are likely to cause OIC, and patients deserve to have nurses caring for them who recognize this.
When the adverse effects of opioids were identified by the patients, constipation was at the top of that list, with 80% reporting this as the worst problem (Table 4). This finding is consistent with earlier studies finding OIC to be a common problem in a variety of cancer populations.4,6,27-29
A large majority of both patients and caregivers indicated that the patients had pain at some time, with the largest number indicating that the frequency was daily (Table 3). However, given that the patients had to be receiving opioids to get into the study, it is puzzling that even a small group would report no pain. It is possible that because of their opioids, small groups of patients and caregivers were reporting that the patients no longer had pain and thus could not reasonably identify the frequency of a symptom they no longer were experiencing, or it may be that the patients were receiving opioids for the treatment of some other symptom, such as dyspnea.
Satisfaction with the current level of pain control was generally very high. This may mean that the patients, all of whom were receiving opioids, were, in fact, getting adequate pain relief. However, that would not be consistent with findings of earlier studies of cancer patients in hospice care13,14 that found that pain relief was not adequate in many cases. Another explanation might be that the patients were receiving some dose of opioid and thus believed that nurses and physicians were doing all that could be done; thus, in that case, they were satisfied with the efforts more than the relief. Intensity of pain was not measured as part of this study.
Although most patients and nurses believed opioids to be essential in managing pain and in improving quality of life, most patients reported frustration with the constipation caused by the opioids. Constipation was, by far, the most commonly cited (80%) opioid adverse effect by this group of patients. That may be because the one adverse effect that every opioid has in common is constipation. Even the weakest opioids are known to cause constipation.5,7,9 Thus, the study finding should not be surprising.
When OIC becomes a problem, there are two approaches to fix it. One is to treat the constipation with laxatives, stool softeners, increased fluid, high bulk diet, and exercise. The other is to target the cause of the constipation-the opioid. A total of 76% of the patients reported taking the second course of action at some time (Table 5). Some reduced the dose, some switched opioids, and some stopped taking the opioids. Although smaller numbers of caregivers reported making these changes, they did make them. This is one of the biggest problems with OIC. Healthcare providers give opioids because patients are having pain. In this group of hospice-eligible and end-stage cancer patients, pain is likely to be a significant problem. At this stage of life, quality of life is an important issue. Both OIC and pain that result from inadequate opioid dosing have the potential to interfere with that quality of life and thus are to be avoided. Nurses, patients, and caregivers all agreed that it would be much easier to manage pain if the effects of OIC could be better controlled. It seems that controlling OIC should be the focus of more research.
Patients and caregivers were asked directly how problematic OIC was and how many episodes the patient had experienced. Most patients and caregivers indicated that OIC is problematic, with most patients experiencing more than five episodes of OIC. Again, these data support the need for remedies to be available for OIC. However, only limited intervention research has been done, and that which has been done has primarily eliminated cancer patients and patients at the end of life.5,22,30
Nurses' attitudes were probed as part of this study. Nurses seemed to agree on the disadvantages of OIC. A large majority indicated that it diminishes quality of life, makes it difficult to provide good care, distracts patients from focusing on other important aspects of life, and takes time (Table 6). Patients supported these nurse attitudes with their own responses. They indicated that OIC interfered with their ability to stay active and engaged, to stay in control, and to reduce pain, among other things (Table 7). All of these data point to the challenge facing patients, informal caregivers, and nurses in dealing with OIC, but also confirm the importance of addressing this issue clinically and through future studies.
Caregivers were asked what impact the patient's constipation had on their own lives. The most commonly cited problems were work related or related to socialization (Table 10). Note that the question was not about being a caregiver in its totality. Instead, the question asked about the OIC and its effect on the caregiver. It is remarkable that caregivers spent so much time dealing with this issue that it made them unable to go to work or made them late when they did go or caused them to have to leave work early. Further, it is noteworthy that OIC would cause them to be unable to socialize with friends, attend social events, or miss some or all of a family outing. It is clear from these data that OIC has a negative effect on quality of life, not only for the patients, but also for the family caregivers as well.
Patients do not seem to know to whom they can turn for help with OIC. Nurses reported that they must initiate the conversation about OIC and that the patients seem reluctant and embarrassed to discuss it. This increases the need for all healthcare providers to be alert to the risk of OIC and to approach the patient early in their relationship about the need for open discussion and the inevitability of OIC if opioids are used. A matter-of-fact attitude on the part of the healthcare provider should assist the patient and caregiver to see that they do not need to be embarrassed or reluctant to discuss this important issue.
On a positive note, nurses reported a number of activities that the patients could do once their OIC was resolved. The list was long, with the two most common activities relating to eating and nutrition (Table 8). When the patient is bloated because of OIC, nutrition can suffer, and at a time when nutrition is particularly important to both the patient and family. Eating is often part of family socializing, an important element of quality of life for both patients and family members. Managing OIC so that the patients are able to eat, socialize, spend time outside, and attend religious services and other desirable activities seems like a really important way to improve many aspects of quality of life.
The results of this study demonstrate that the patients, family caregivers, and nurses all recognize the significance of OIC and its negative impact on both patients and families and appreciate the importance of successful management of this distressing symptom. Constipation is among the most nurse-sensitive outcomes; that is, if it is appropriately assessed and managed, nurses, working with the interdisciplinary team, can have a big impact on improving the patient's quality of life by decreasing OIC symptom occurrence, intensity, and distress. In addition, successful management of OIC can increase nursing efficiency in care provision. Content about OIC should be included in pharmacology and medical and surgical courses in both nursing and medical schools and should be the focus of continuing education for all healthcare professionals. However, this continuing education that is needed would be more meaningful if it could be based on results of clinical trials conducted to test the most appropriate interventions for OIC. Unfortunately, research of this type is largely lacking and needs to be conducted. Future studies should focus no only on the incidence, trajectory, intensity and distress of OIC but also should include randomized clinical trials of methods of alleviating this serious problem.
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For more than 22 additional continuing education articles related to pain management, go to NursingCenter.com\CE.
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