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Randomized Clinical Trial of the Effectiveness of a Self-Care Intervention to Improve Cancer Pain Management

From the Schools of Nursing and Pharmacy, University of California San Francisco, San Francisco, CA; School of Nursing, University of Pennsylvania, Philadelphia, PA; and School of Medicine, University of Texas Southwestern Medical Center at Dallas, Dallas, TX.

Address reprint requests to Christine Miaskowski, RN, PhD, Department of Physiological Nursing, University of California, 2 Koret Way, Box 0610-N631Y, San Francisco, CA 94143-0610; e-mail: chris.miaskowski{at}nursing.ucsf.edu

	ABSTRACT

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
PURPOSE: This randomized clinical trial tested the effectiveness of the PRO-SELF Pain Control Program compared with standard care in decreasing pain intensity scores, increasing appropriate analgesic prescriptions, and increasing analgesic intake in oncology outpatients with pain from bone metastasis.

PATIENTS AND METHODS: Patients were randomly assigned to the PRO-SELF intervention (n = 93) or standard care (n = 81). Patients in the standard care arm were seen by a research nurse three times and were called three times by phone between the home visits. PRO-SELF group patients were seen by specially trained intervention nurses and received a psychoeducational intervention, were taught how to use a pillbox, and were given written instructions on how to communicate with their physician about unrelieved pain and the need for changes in their analgesic prescriptions. Patients were coached during two follow-up home visits and three phone calls on how to improve their cancer pain management.

RESULTS: Pain intensity scores decreased significantly from baseline (all P < .0001) in the PRO-SELF group (ie, least pain, 28.4%; average pain, 32.5%; and worst pain, 27.0%) compared with the standard care group (ie, least increased by 14.6%, average increased by 1.9%, and worst decreased by 1.2%). The percentage of patients in the PRO-SELF group with the most appropriate type of analgesic prescription increased significantly from 28.3% to 37.0% (P = .008) compared with a change from 29.6% to 32.5% in the standard care group.

CONCLUSION: The use of a psychoeducational intervention that incorporates nurse coaching within the framework of self-care can improve the management of cancer pain.

	INTRODUCTION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
The undertreatment of cancer pain is a major public health problem. Numerous studies have documented this undertreatment as well as its negative consequences.^1–8 However, the number of randomized clinical trials (RCTs) that have tested the effectiveness of patient interventions to improve cancer pain management^9,10 is extremely limited given the deleterious effects of unrelieved pain on oncology patients' functional status, mood, and quality of life.

Only four RCTs^11–14 have tested the effectiveness of a psychoeducational intervention for patients with cancer pain. Most of these studies^12–14 were small in size and the results were disappointing. Given the variability of methods and the lack of information regarding analgesic intake in this small number of RCTs,^11–14 we conducted an RCT that tested the effectiveness of the PRO-SELF Pain Control Program compared with standard care in improving cancer pain management. The primary objective of this study was a reduction in pain intensity scores (ie, least, average, and worst) over the 6-week study period in patients in the intervention group compared with those in the standard care group. The secondary objectives were an increase in opioid analgesic intake and an increase in the percentage of patients with an appropriate analgesic prescription at the end of the study in the patients in the intervention group compared with those in the standard care group.

This study builds on the work of Dodd et al^15–17 at the University of California San Francisco, who developed the PRO-SELF Program to provide oncology patients with the knowledge, skills, and nursing support that are necessary to manage disease and treatment-related problems. For this study, we chose to enhance the major components of the PRO-SELF Program with the use of the strategies of academic detailing^18,19 and nurse coaching.^20,21 In brief, academic detailing is a strategy that has been used to change physicians' behaviors through the provision of brief, detailed information on a specific aspect of their practice through a face-to-face encounter with a credible professional. This approach has reduced the number of inappropriate prescriptions and improved patient outcomes.^19,20 However, to our knowledge, it has not been used with cancer patients to change self-care behaviors. Nurse coaching is an effective strategy to reinforce educational content and provide individualized support to patients that results in changes in the patients' behaviors.^20,21

	PATIENTS AND METHODS

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
Patient Population
Two hundred twelve oncology outpatients, who were experiencing pain from bone metastasis, were recruited from seven outpatient settings in Northern California: a university-based cancer center, two community-based oncology practices, one health maintenance organization, one outpatient radiation therapy center, one veteran's affairs facility, and one military hospital. The participants were adult oncology outpatients (> 18 years old) who were able to read, write, and understand English. All participants had Karnofsky performance scores of 50, average pain intensity scores of 2.5, and radiographic evidence of bone metastasis. Patients were excluded if they had an identified family caregiver who could not or would not participate in the intervention. The study was approved by the Human Subjects Committee at the University of California San Francisco, and at each of the study sites, and all of the patients and family caregivers signed a written informed consent.

Intervention
Specific details of the study procedures are described elsewhere.^22,23 In brief, patients were approached in the outpatient setting by a recruitment nurse who explained the study and obtained written informed consent. Patients were stratified by site and on the basis of whether they participated by themselves or with a family caregiver. Both patients and clinicians at the study sites were blinded to the patient's group assignment. Patients were randomly assigned to either the PRO-SELF or the standard care group. At the time of enrollment, patients completed a demographic questionnaire, the Karnofsky performance score,²⁴ and for 1 week before the first study visit, patients rated their level of pain intensity on a daily basis. At the beginning and end of the study, the patients' medical records were reviewed.

Patients in the standard care group received the patient version of the Cancer Pain Guideline published by the Agency for Health Care Policy and Research (AHCPR)²⁵ and were seen by a research nurse in their homes at weeks 1, 3, and 6. Telephone interviews were conducted at weeks 2, 4, and 5. The focus of the visits and phone calls was on monitoring patients' level of adherence with completing the diary.

Patients in the PRO-SELF group received the intervention by a different group of specially trained oncology nurses. At the week 1 visit, the PRO-SELF nurse conducted the academic detailing session with the patient and family caregiver. This academic detailing session was tailored to meet the individual learning needs of the patient and the family caregiver on the basis of their responses to a knowledge and attitude survey about cancer pain management.²⁶ The nurse identified the specific areas of knowledge deficit and focused the education in these areas. In addition, patients were given written instructions regarding pain and side effect management, were taught how to use a weekly pillbox, and were taught how to use a script to assist them in communicating with their physician about unrelieved pain and the need for a change in their analgesic prescription.

During weeks 2, 4, and 5, the PRO-SELF nurse contacted patients in the intervention group by phone and reviewed their pain intensity scores and pain medication intake. The educational content of the PRO-SELF Program was reinforced and patients were coached about how to modify their pain management plan or how to contact their physicians to improve pain outcomes. Most of the coaching took place during the phone calls and follow-up home visits. The PRO-SELF nurse coached the patients in the following areas: how to improve pain relief by altering the times and frequency of analgesic intake while staying within the parameters of the analgesic prescription; how to assess pain and their response to analgesics; how to use strategies to prevent or treat analgesic side effects; and how to speak with their healthcare providers if the analgesic prescription was not adequate and needed to be changed. The PRO-SELF nurse made home visits during weeks 3 and 6. Again, previous teaching was reinforced and patients were coached about how to make changes in their pain management plan.

Outcome Assessments
The primary outcome of this study was a significant reduction in pain intensity scores (ie, least, average, worst), over the 6 weeks of the study in patients in the intervention group compared with those in the standard care group. To obtain the measures of pain intensity, patients recorded average, worst, and least pain intensity scores before bedtime for 6 weeks using a descriptive numeric rating scale that ranged from 0 (none) to 10 (excruciating).^27–29

The secondary outcomes were an increase in opioid analgesic intake and an increase in the percentage of patients with an appropriate analgesic prescription at the end of the study in patients in the intervention group compared with those in the standard care group. To determine opioid analgesic intake, the research nurse recorded the name, dose, and administration schedule for all of the prescribed and over-the-counter pain medications. Then, on a daily basis, patients recorded the time and the amount of opioid, nonopioid, and coanalgesic medications taken on an around-the-clock (ATC) and on an as-needed (ie, PRN) basis. If a change in the analgesic prescription occurred, patients were instructed to make the change in their diary. The research nurse verified the patients' current pain medication regimen at each study visit and checked the diary entries for completeness. All opioid analgesics were converted to morphine equivalents. Total doses of opioid analgesics and doses of ATC opioids, prescribed and taken on a 24-hour basis, were calculated and then averaged for each week of the study. Differences from baseline in total doses of opioid analgesics and doses of ATC opioids, prescribed and taken on a 24-hour basis, were calculated.

To determine if the types of analgesic prescriptions changed in the PRO-SELF and standard care groups, each patient's pain prescription on the first day of the study and on the last day of the study was categorized as one of the following: only ATC opioid, only PRN opioid, both ATC and PRN opioid, or no opioid based on the physician's prescription that was verified by the research nurse during the home visits.

Data Analysis
To have adequate power to test the main effect of treatment group on pain intensity, a total sample of at least 150 patients needed to complete the study. Such a sample size allows detection of a moderate effect size of f = 0.23 (percent of explained variance approximately 5%) with power of at least 0.80 and = .05. This effect size estimate corresponds to a difference in mean pain intensity ratings between the PRO-SELF and standard care groups of approximately one full point on the 10-point numeric rating scale.

Descriptive statistics and frequency distributions were generated for the patients' demographic and disease-related characteristics. Daily ratings of pain intensity were averaged on a weekly basis. Independent Student's t tests and ² analyses were performed to determine if there were differences in any demographic, disease, and baseline pain characteristics between patients in the PRO-SELF and standard care groups. Two-way, repeated measures analyses of variance were done to determine if changes in pain intensity scores occurred over time and whether these changes differed by group; and if changes from baseline occurred over time in the total amount of opioid analgesics, as well as in the amount of ATC opioid analgesic prescribed and taken on a 24-hour basis. The McNemar test was used to evaluate for differences over time in the types of analgesic prescriptions. All calculations used actual values. Adjustments were not made for missing data. Therefore, the cohort for each analysis was dependent on the largest complete set of data across the groups. A P value of less than .05 was considered statistically significant.

	RESULTS

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
Sample Demographics
One hundred seventy-four patients who were experiencing pain from bone metastasis completed the study and are included in this analysis. Thirty-eight patients (ie, 22 in the PRO-SELF group and 16 in the standard care group) did not complete the entire study for a variety of reasons, including increased severity of illness or intervening cancer treatments that required hospitalization (n = 28; 16 in the PRO-SELF group and 12 in the standard care group) and death (n = 10; six in the PRO-SELF group and four in the standard care group). No differences were found in any of the demographic, disease, or baseline pain characteristics between patients who did and did not complete the study. The percentage of participants who did not complete the entire study did not differ significantly by treatment group (ie, 19% for the PRO-SELF group and 17% for the standard care group; P = .72).

The demographic and disease characteristics of the patients in the PRO-SELF (n = 93) and standard care groups (n = 81) are summarized in Table 1. No significant differences were found in any of the demographic or disease characteristics between patients in the two groups.

View larger version (16K): [in this window] [in a new window]   Fig 1. (A, B, and C) Changes in pain intensity scores, over time, for patients in the PRO-SELF (n = 93) and standard care (n = 81) groups plotted as means ± SEs of the mean (some error bars are contained within the symbols).

For least pain, a significant group x time interaction (P < .0001) as well as a significant main effect of time (P = .009) but not group (P = .117) were found. Tests of simple effects within the two groups showed a significant decrease in least pain scores over time in the intervention group (P < .0001) and a significant increase in least pain scores over time in the standard care group (P = .014).

Changes in Opioid Analgesic Prescriptions
The types of analgesic prescriptions at the beginning and at the end of the study for patients in the PRO-SELF and standard care groups are listed in Table 4. In the PRO-SELF group, the percentage of patients with the most appropriate type of analgesic prescription (ie, ATC + PRN) increased significantly from 28.3% to 37.0% (P = .008; ie, an 8% increase). In the standard care group, the percentage of patients with the most appropriate type of analgesic prescription increased from 29.6% to 32.5%. This 2.9% increase was not statistically significant (P = .51) and the amount of increase between the two groups was not significantly different.

View larger version (24K): [in this window] [in a new window]   Fig 2. Changes, from baseline, in total dose of opioid analgesics (A) prescribed and (B) taken on a 24-hour basis for patients in the PRO-SELF (n = 92) and standard care (n = 80) groups. Changes, from baseline, in around-the-clock dose of opioid analgesic (C) prescribed and (D) taken on a 24-hour basis for patients in the PRO-SELF (n = 46) and standard care (n = 33) groups. All values are plotted as means ± SEs of the mean.

	DISCUSSION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
This study is the first to demonstrate that the use of a psychoeducational intervention that incorporates the principles of academic detailing and nurse coaching within the framework of self-care can improve the management of cancer pain. Mean percentage decreases from baseline for all three of the pain intensity scores represent clinically significant reductions in pain for the majority of the patients^30,31 and are comparable to previous reports.^11,12 However, this 6-week intervention did not achieve complete pain relief, which might be explained by two recent meta-analyses demonstrating that most behavioral intervention programs take 8 to 10 weeks to achieve maximal changes in behavior.^32,33

Because this patient population had pain from bone metastasis, one might expect that pain intensity scores in the standard care group would have increased over time. The fact that this increase did not occur suggests that patients in the standard care group may have modified some of their pain management behaviors because they were completing the daily pain management diary and reading the patient version of the AHCPR Cancer Pain Guideline.²⁵ In fact, during an end-of-study interview, patients in the standard care group told us that they found the diary useful.²³

The decreases in pain intensity scores in the PRO-SELF group might be attributable to three factors: changes in the type of analgesic prescriptions, changes in analgesic intake, and changes in the patients' perceptions of their pain experience. As noted in the AHCPR Cancer Pain Guideline,³⁴ patients with chronic cancer pain should receive a prescription for a long-acting opioid analgesic that can be taken ATC, as well as for a short-acting analgesic that can be taken on a PRN basis for breakthrough pain. Of note, at the beginning of the study, less than 30% of the patients in both groups had this type of analgesic prescription. At the end of the study, 37% of the patients in the PRO-SELF group had the more appropriate prescription compared with 32.5% of the patients in the standard care group.

One of the changes in the patients' behaviors was that patients in the PRO-SELF group increased their intake of analgesic medications. Although not statistically significant, on average, patients in the PRO-SELF group had increased their total consumption of opioid analgesics and their consumption of ATC opioid analgesics. However, significant differences in prescription doses were not found between the two groups because of the large degree of interindividual variability in the doses prescribed to patients in both groups. One of the reasons we chose a homogeneous sample of oncology outpatients with a single etiology for their pain was to reduce some of the variability in the analgesic prescriptions. However, our data confirm the need to develop individual plans of care for each oncology patient who experiences cancer pain. In addition, the large degree of interindividual variability in analgesic doses needs to be considered in future studies that attempt to use analgesic intake as an outcome measure.

Another explanation for the decreases in pain intensity scores reported by patients in the PRO-SELF group is that these patients might have changed their perceptions of their cancer pain experience as a result of the education, skills training, and coaching provided by the nurses. This hypothesis is plausible given the fact that the initial RCT with the PRO-SELF intervention did not demonstrate statistically significant differences in chemotherapy morbidity.³⁵ However, an analysis of data from the semistructured interviews found that 91% of the patients in the experimental group found the PRO-SELF Program helpful in managing the side effects of chemotherapy.^15,16 Additional research is warranted to determine the active ingredients in this psychoeducational intervention.

Although NSAIDs produce synergistic effects when combined with opioids³⁵ and might be useful in the management of pain from bone metastasis,^36,37 only about half of the patients in both groups had NSAIDs prescribed at the beginning of the study. Of note, no differences were found between the two groups in the percentage of patients who began taking an NSAID or corticosteroid, or who received radiation therapy or a radiopharmaceutical after the initiation of the study. Future studies need to investigate the effects of these coanalgesics on the management of pain from bone metastasis.

Several limitations of this study are worth noting. The majority of the patients were white and well educated. Therefore, we cannot determine whether this approach will work as well with patients from other ethnic groups or in individuals with less education. In addition, because we did not schedule follow-up visits with the patients after the intervention was completed, we do not know if the behavior changes that occurred as a result of the PRO-SELF Program are sustained for a period of time after the intervention stopped.

Admittedly, the PRO-SELF Pain Control Program is labor intensive and time consuming. However, teaching patients new skills to manage other medical problems (eg, diabetes) is equally challenging. Future research needs to focus on the development of less time-intensive approaches that will be equally or more effective.

Authors' Disclosures of Potential Conflicts of Interest
The authors indicated no potential conflicts of interest.

	Acknowledgment

 
We acknowledge the support and assistance of the physicians and nurses at our study sites and our project staff. We are grateful to all of the patients and family caregivers who participated in this study. We thank Craig Carlson and Fu Kato for technical assistance with this manuscript.

	NOTES

 
Supported by a grant (CA 64734) from the National Cancer Institute. Additional support for the corresponding author's program of research was provided through unrestricted grants from Janssen Pharmaceutica and Purdue Pharma LP.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

	REFERENCES

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Submitted June 24, 2002; accepted January 23, 2004.

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This Article Abstract Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Miaskowski, C. Articles by Koo, P. Search for Related Content PubMed PubMed Citation Articles by Miaskowski, C. Articles by Koo, P. Social Bookmarking                            What's this?