Original Article
Automated Pain Intervention for Underserved Minority Women With Breast Cancer Karen O. Anderson, PhD, MPH1; Guadalupe R. Palos, DrPH, LMSW, RN2; Tito R. Mendoza, PhD1; Charles S. Cleeland, PhD1; Kai-Ping Liao, PhD, MHA3; Michael J. Fisch, MD, MPH4; Araceli Garcia-Gonzalez, MD, DSc1; Alyssa G. Rieber, MD4; L. Arlene Nazario, MD4; Vicente Valero, MD5; Karin M. Hahn, MD, MPH6; Cheryl L. Person, MD7; and Richard Payne, MD8
BACKGROUND: Minority patients with breast cancer are at risk for undertreatment of cancer-related pain. The authors evaluated the feasibility and efficacy of an automated pain intervention for improving pain and symptom management of underserved African American and Latina women with breast cancer. METHODS: Sixty low-income African American and Latina women with breast cancer and cancer-related pain were enrolled in a pilot study of an automated, telephone-based, interactive voice response (IVR) intervention. Women in the intervention group were called twice weekly by the IVR system and asked to rate the intensity of their pain and other symptoms. The patients’ oncologists received e-mail alerts if the reported symptoms were moderate to severe. The patients also reported barriers to pain management and received education regarding any reported obstacles. RESULTS: The proportion of women in both groups reporting moderate to severe pain decreased during the study, but the decrease was significantly greater for the intervention group. The IVR intervention also was associated with improvements in other cancer-related symptoms, including sleep disturbance and drowsiness. Although patient adherence to the IVR call schedule was good, the oncologists who were treating the patients rated the intervention as only somewhat useful for improving symptom management. CONCLUSIONS: The IVR intervention reduced pain and symptom severity for underserved minority women with breast cancer. Additional research on technological C 2015 American Cancer Society. approaches to symptom management is needed. Cancer 2015;121:1882-90. V KEYWORDS: breast cancer, minority groups, pain, symptoms, assessment.
INTRODUCTION Inadequate treatment of pain among minority patients with cancer has been documented in multiple studies.1,2 When minority patients are underserved because of limited financial resources, they are particularly at risk. Although most minority populations have a lower incidence of breast cancer than non-Hispanic white populations, minority patients are more likely to be diagnosed with advanced disease and may be at particular risk for pain and related symptoms.3 Although the results of descriptive studies suggest that underserved minority patients might benefit from education about cancer pain, the results of a randomized clinical trial indicated that education alone did not improve pain management.4 We concluded that an intervention targeting multiple patient, provider, and health care system barriers is needed to optimize pain management. However, multicomponent interventions are difficult to implement in understaffed public hospitals. Although traditional telephone communication is not feasible for repeated assessment, combining telephones with computerized assessment may be an effective way to follow patients’ pain. Interactive voice response (IVR) and Web-based systems have been used effectively to monitor symptoms associated with chemotherapy5-14 and stem cell transplantation.15,16 To our knowledge, however, no previous studies have evaluated an IVR system that was specifically designed for underserved minority women with breast cancer. In the current study, we evaluated an automated, telephone-based IVR system that measures
Corresponding author: Tito R. Mendoza, PhD, Associate Professor, Department of Symptom Research, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 1450, Houston, TX 77030; Fax: (713) 745-3475; [email protected] 1 Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.; 2Office of Cancer Survivorship, The University of Texas MD Anderson Cancer Center, Houston, Texas.; 3Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.; 4 Department of General Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.; 5Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.; 6London Regional Cancer Program, London Health Sciences Center, London, Ontario, Canada; 7Department of Psychiatry and Behavioral Sciences, The University of Texas Health Sciences Center, Houston, Texas.; 8Duke Institute on Care at the End of Life, Duke University Divinity School, Durham, North Carolina.
We acknowledge Katherine Gilmore, MPH, and Lucy Balderas, BA, for recruitment and retention efforts and Jeanie Woodruff, BS, ELS, for editorial support. The authors evaluate the feasibility and efficacy of an automated pain intervention for improving pain and symptom management in underserved African American and Latina women with breast cancer. The intervention reduces pain and symptom severity for the women, indicating that further research on technological approaches to symptom management is warranted. DOI: 10.1002/cncr.29204, Received: November 26, 2013; Revised: August 15, 2014; Accepted: September 2, 2014, Published online February 24, 2015 in Wiley Online Library (wileyonlinelibrary.com)
1882
Cancer
June 1, 2015
Breast Cancer Pain Intervention/Anderson et al
patients’ pain and symptom levels, alerts providers when a symptom is moderate to severe, and assesses barriers to pain control. Our specific objectives were: 1) to pilot test the efficacy of the IVR intervention for improving pain and pain-related symptoms in minority patients with breast cancer compared with the current standard of care, and 2) to evaluate the feasibility of the IVR intervention. We hypothesized that minority patients in the intervention group would demonstrate reduced severity of pain and related symptoms. MATERIALS AND METHODS Setting and Patients
The patients were recruited in the outpatient medical oncology clinic of a large public hospital in Houston, Texas, that treats underserved patients. Patients who receive treatment at this hospital are required to meet incomebased eligibility criteria based on federal poverty-level guidelines. The patients were approached by bilingual female research staff in private clinic rooms. Eligibility criteria included: 1) outpatient in the oncology clinic, 2) breast cancer diagnosis confirmed by pathology, 3) selfreport of being black/African American or Latina/Hispanic, 4) English-speaking or Spanish-speaking, 5) aged 18 years, 6) chronic cancer-related pain, and 7) a “pain worst” score 4 on a scale from 0 to 10. The patient’s oncologist confirmed that the pain was related to cancer or cancer treatment17 but did not participate in the recruitment process. If an eligible patient agreed to participate, then the staff obtained written informed consent and scheduled the baseline assessment, which was to be conducted in English or Spanish, depending on patient preference. The patients were stratified by minority group and randomly assigned to the intervention group or the control group by an electronic protocol management system. The Institutional Review Boards of The University of Texas MD Anderson Cancer Center and the Harris Health System approved the study. IVR Intervention
The IVR system was demonstrated at baseline to patients in the intervention group, who then practiced using the system. The research staff explained that the system would call 2 times per week for 8 weeks at preferred times. The system asked patients to identify themselves using a study number, and then the IVR symptom script began. Patients reported their responses using the touch-tone telephone keypad. If a patient did not have telephone access during the study, then a cell telephone was provided. If a patient did not answer an IVR call, then the system Cancer
June 1, 2015
repeated the call up to 3 times on the same day, spaced 45 minutes apart. If the calls were not answered, then the system notified the research staff, who contacted the patient by telephone and verbally administered the symptom items.18 The IVR intervention consisted of: 1) assessment of patients’ pain and related symptoms, 2) determination of pain or other symptoms that exceeded a severity threshold, 3) feedback of information about suprathreshold symptoms to the physician, and 4) assessment of patientrelated barriers. The barriers assessed included: 1) nonadherence to analgesic medications; 2) difficulty obtaining analgesic medications; 3) side effects from medications; 4) concerns about opioids, such as fear of addiction; 5) reliance on alternative strategies (eg, herbs) for pain management; and 6) lack of family support for pain management. When a patient reported a barrier, a member of the research staff contacted the patient by telephone and provided educational information regarding the barrier and how to overcome it.4 A standardized English/Spanish script was used and was followed by an opportunity for questions. Pain
When the patient’s reported pain level was 5 on the scale from 0 to 10, the IVR system immediately forwarded this information by e-mail to the patient’s physician. The patients in the clinic are treated by oncology fellows who are supervised by attending oncologists. The e-mail alerts were sent to the patient’s oncology fellow, and a copy was sent to the attending oncologist. The research staff monitored the IVR alerts on a Web-based intranet site and sent an e-mail to the physician who received the alert that contained a form for documentation of response. Other symptoms
The IVR assessed 12 additional symptoms contained in the MD Anderson Symptom Inventory (MDASI).19 In addition to pain, 6 symptoms (nausea, vomiting, emotional distress, sadness, drowsiness, and shortness of breath) were identified by the oncologists as symptoms that should generate e-mail alerts. The symptoms nausea, vomiting, distress, sadness, and drowsiness triggered an alert when the level was 5. For shortness of breath, the alert threshold was designated as 3. No specific thresholds were set for fatigue, sleep disturbance, lack of appetite, dry mouth, difficulty remembering, or numbness/ tingling. The physicians were provided with the intervention group’s most recent IVR symptom ratings before the patients’ clinic visits. 1883
Original Article Control Group
Patients in the control group received the usual pain and symptom management interventions given by the clinic physicians. The patients completed the paper-and-pencil assessments at baseline and at 2 follow-up assessments. They were informed that their symptom data would be used for research purposes only and would not be provided to their clinicians. All patients were instructed to report any symptoms to their physicians. Outcomes Assessment
The outcome measures were administered to all patients in the study during clinic visits at time point 1 (4-6 weeks after enrollment in the study) and at time point 2 (8-10 weeks after enrollment). Instruments MDASI. The MDASI contains 13 symptom items that are rated from 0 to 10 on numeric scales. The reliability and validity of the MDASI have been demonstrated.19,20 The Spanish language version of the MDASI has been validated.21
The Barriers Questionnaire II (BQ-II) was developed to measure patient beliefs that are barriers to optimal pain treatment. The BQ-II has demonstrated excellent reliability and validity.22-24 The Spanish language version of the questionnaire has been validated.25 Barriers Questionnaire-II.
Other measures
The Eastern Cooperative Oncology Group performance status scale was used to assess the physician’s estimate of the patient’s functional status at baseline.26 This scale is an observational measure of functional ability that has demonstrated excellent reliability and validity.27,28 Performance status.
Biomedical variables. Biomedical information was recorded from the patients’ electronic medical records. Pain management index. The analgesic data were used to compute a pain management index (PMI) score at each assessment.29 Pain management is considered adequate when there is congruence between the patient’s pain severity and the appropriateness of the prescribed analgesic. Negative PMI scores indicate under-medication, and scores 0 are considered a conservative indicator of acceptable treatment. Patient demographic form. Patients completed a demographic questionnaire, which included questions about age, race, and ethnicity.
1884
The feasibility of the intervention was evaluated by determining rates of recruitment and retention, patient adherence to the call schedule, rates of physician receipt and response to the alerts, and physician evaluation of the IVR system.
Feasibility measures.
Statistical Analysis
For this pilot study, we planned to enroll a total of 60 patients. Our objectives were to pilot the intervention, obtain an estimate of its effect, and collect feasibility measures. Our power analysis indicated that we could detect a standardized difference of 0.74 in mean pain severity ratings between the the control and intervention groups using a 2-tailed test at an a level of. 05 and. 80 power. We used descriptive statistics to describe how patients rated pain and symptom severity. Proportions of patients who rated their symptoms as moderate to severe (5 on a 0-10 scale) were reported.30 Potential differences between patient groups based on demographic variables were explored using chi-square tests or t tests. If the normality assumption was not met for the t test, then the Wilcoxon test was used. Nominal P values were reported. To evaluate the effectiveness of the IVR intervention, linear mixed models were used to evaluate changes in mean pain and symptom severity across time. A groupby-time interaction term was included in each model. In addition, a random intercept was included to account for baseline variations in pain and symptom severity. Performance status and PMI scores were entered as covariates to control for possible effects of function and pain management. The PMI score was not included in the model for pain severity. Generalized estimating equation analysis was used to determine the likelihood of observing a higher number of symptom threshold events in the intervention group. To address our hypothesis that the severity of pain would be reduced in the intervention group, we used the McNemar test to compare the proportions of patients with moderate to severe pain across time. In addition, we calculated the PMI score for each patient and performed a chi-square test to compare the proportions of patients whose pain was inadequately managed in the IVR and control groups. To address our hypothesis that the severity of pain-related symptoms, such as sleep disturbance and emotional distress, would be reduced in the intervention group, we used linear mixed models to compare painrelated symptoms between the IVR and control groups. The McNemar test was used to compare the proportions of patients with moderate to severe symptoms across time. Cancer
June 1, 2015
Breast Cancer Pain Intervention/Anderson et al
Figure 1. This Consolidated Standards of Reporting Trials (CONSORT) flow diagram illustrates patient flow throughout the study.
Secondary Analyses
We used the t test or its nonparametric counterpart to compare BQ-II scores between the groups at baseline and at time point 1, and between the groups at baseline and at time point 2. The primary endpoints for the evaluation of feasibility were the recruitment and retention rates; and secondary variables were patient adherence to the symptom assessment, frequency of alerts and responses to alerts, and physician evaluation of the intervention. RESULTS Patient Characteristics
Of the 449 patients with breast cancer who were screened for eligibility, 73 patients were eligible and were approached regarding participation in the study (Fig. 1), and 60 patients agreed to be enrolled. Reasons for refusal included lack of time (n = 2), reluctance to complete questionnaires (n = 2), financial concerns (n = 1), lack of interest (n = 1), and unknown (n = 7). Eighty-four percent of the intervention group and 72% of the control group completed the first follow-up assessment, and 68% of the Cancer
June 1, 2015
intervention group and 86% of the control group completed the second follow-up assessment. Demographic and clinical characteristics of the 60 participants are listed by group assignment in Table 1. The mean 6 standard deviation time since cancer diagnosis was 2.0 6 3.3 years, with no significant differences between groups. No significant baseline differences were observed between the intervention and control groups or between African American and Latina women, between younger women versus older women, or by disease stage. Most patients were receiving active treatments, but 16 patients (27%) had recently finished treatment or were waiting for treatment to begin. Among the Latina patients, 74% described Spanish as their primary language. Symptom Alerts
During the study, 71% of the IVR assessments were completed successfully. In total, 221 symptom alerts were generated for patients in the intervention group for pain (n = 164), drowsiness (n = 140), emotional distress (n = 109), 1885
Original Article TABLE 1. Baseline Demographic and Disease Variables Among African American and Latina Women With Breast Cancer No. of Patients (%)
Characteristic Age: Mean 6 SD, y Education: Mean 6 SD, y Ethnic group African American Latina Marital status Married Unmarried Employment status Unemployed Employed Homemaker Retired Other Disease stage IIA-IIB IIIA-IIIB IV Unknown Disease status No evidence of disease Local/regional Metastatic Unknown Treatment status Chemotherapy Radiotherapy Hormone therapy Immunotherapy Noneb Patients with severe painc Good performance statusd
Intervention Group, n = 31
Control Group, n = 29
49.6 6 9.9 10.6 6 4.1
50.5 6 11.0 10.0 6 2.9
13 (42) 18 (58)
12 (41) 17 (59)
15 (48) 16 (52)
13 (45) 16 (55)
16 (52) 2 (6) 7 (23) 4 (13) 2 (6)
15 (52) 4 (14) 8 (28) 2 (7) 0 (0)
7 (23) 11 (35) 11 (35) 2 (6)
7 (24) 12 (41) 10 (34) 0 (0)
4 (13) 14 (45) 11 (35) 2 (6)
4 (14) 12 (41) 12 (41) 1 (3)
14 (45) 1 (3) 5 (16) 2 (6) 9 (29) 21 (68) 14 (45)
17 (59) 0 (0) 3 (10) 2 (7) 7 (24) 23 (79) 15 (45)
Pa .76 .51 .97
.78
.31
.91
.91
.44
Differences in pain severity
Linear mixed models for mean pain scores on the MDASI revealed a significant time effect (P
Automated Pain Intervention for Underserved Minority Women With Breast Cancer Karen O. Anderson, PhD, MPH1; Guadalupe R. Palos, DrPH, LMSW, RN2; Tito R. Mendoza, PhD1; Charles S. Cleeland, PhD1; Kai-Ping Liao, PhD, MHA3; Michael J. Fisch, MD, MPH4; Araceli Garcia-Gonzalez, MD, DSc1; Alyssa G. Rieber, MD4; L. Arlene Nazario, MD4; Vicente Valero, MD5; Karin M. Hahn, MD, MPH6; Cheryl L. Person, MD7; and Richard Payne, MD8
BACKGROUND: Minority patients with breast cancer are at risk for undertreatment of cancer-related pain. The authors evaluated the feasibility and efficacy of an automated pain intervention for improving pain and symptom management of underserved African American and Latina women with breast cancer. METHODS: Sixty low-income African American and Latina women with breast cancer and cancer-related pain were enrolled in a pilot study of an automated, telephone-based, interactive voice response (IVR) intervention. Women in the intervention group were called twice weekly by the IVR system and asked to rate the intensity of their pain and other symptoms. The patients’ oncologists received e-mail alerts if the reported symptoms were moderate to severe. The patients also reported barriers to pain management and received education regarding any reported obstacles. RESULTS: The proportion of women in both groups reporting moderate to severe pain decreased during the study, but the decrease was significantly greater for the intervention group. The IVR intervention also was associated with improvements in other cancer-related symptoms, including sleep disturbance and drowsiness. Although patient adherence to the IVR call schedule was good, the oncologists who were treating the patients rated the intervention as only somewhat useful for improving symptom management. CONCLUSIONS: The IVR intervention reduced pain and symptom severity for underserved minority women with breast cancer. Additional research on technological C 2015 American Cancer Society. approaches to symptom management is needed. Cancer 2015;121:1882-90. V KEYWORDS: breast cancer, minority groups, pain, symptoms, assessment.
INTRODUCTION Inadequate treatment of pain among minority patients with cancer has been documented in multiple studies.1,2 When minority patients are underserved because of limited financial resources, they are particularly at risk. Although most minority populations have a lower incidence of breast cancer than non-Hispanic white populations, minority patients are more likely to be diagnosed with advanced disease and may be at particular risk for pain and related symptoms.3 Although the results of descriptive studies suggest that underserved minority patients might benefit from education about cancer pain, the results of a randomized clinical trial indicated that education alone did not improve pain management.4 We concluded that an intervention targeting multiple patient, provider, and health care system barriers is needed to optimize pain management. However, multicomponent interventions are difficult to implement in understaffed public hospitals. Although traditional telephone communication is not feasible for repeated assessment, combining telephones with computerized assessment may be an effective way to follow patients’ pain. Interactive voice response (IVR) and Web-based systems have been used effectively to monitor symptoms associated with chemotherapy5-14 and stem cell transplantation.15,16 To our knowledge, however, no previous studies have evaluated an IVR system that was specifically designed for underserved minority women with breast cancer. In the current study, we evaluated an automated, telephone-based IVR system that measures
Corresponding author: Tito R. Mendoza, PhD, Associate Professor, Department of Symptom Research, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 1450, Houston, TX 77030; Fax: (713) 745-3475; [email protected] 1 Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.; 2Office of Cancer Survivorship, The University of Texas MD Anderson Cancer Center, Houston, Texas.; 3Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.; 4 Department of General Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.; 5Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.; 6London Regional Cancer Program, London Health Sciences Center, London, Ontario, Canada; 7Department of Psychiatry and Behavioral Sciences, The University of Texas Health Sciences Center, Houston, Texas.; 8Duke Institute on Care at the End of Life, Duke University Divinity School, Durham, North Carolina.
We acknowledge Katherine Gilmore, MPH, and Lucy Balderas, BA, for recruitment and retention efforts and Jeanie Woodruff, BS, ELS, for editorial support. The authors evaluate the feasibility and efficacy of an automated pain intervention for improving pain and symptom management in underserved African American and Latina women with breast cancer. The intervention reduces pain and symptom severity for the women, indicating that further research on technological approaches to symptom management is warranted. DOI: 10.1002/cncr.29204, Received: November 26, 2013; Revised: August 15, 2014; Accepted: September 2, 2014, Published online February 24, 2015 in Wiley Online Library (wileyonlinelibrary.com)
1882
Cancer
June 1, 2015
Breast Cancer Pain Intervention/Anderson et al
patients’ pain and symptom levels, alerts providers when a symptom is moderate to severe, and assesses barriers to pain control. Our specific objectives were: 1) to pilot test the efficacy of the IVR intervention for improving pain and pain-related symptoms in minority patients with breast cancer compared with the current standard of care, and 2) to evaluate the feasibility of the IVR intervention. We hypothesized that minority patients in the intervention group would demonstrate reduced severity of pain and related symptoms. MATERIALS AND METHODS Setting and Patients
The patients were recruited in the outpatient medical oncology clinic of a large public hospital in Houston, Texas, that treats underserved patients. Patients who receive treatment at this hospital are required to meet incomebased eligibility criteria based on federal poverty-level guidelines. The patients were approached by bilingual female research staff in private clinic rooms. Eligibility criteria included: 1) outpatient in the oncology clinic, 2) breast cancer diagnosis confirmed by pathology, 3) selfreport of being black/African American or Latina/Hispanic, 4) English-speaking or Spanish-speaking, 5) aged 18 years, 6) chronic cancer-related pain, and 7) a “pain worst” score 4 on a scale from 0 to 10. The patient’s oncologist confirmed that the pain was related to cancer or cancer treatment17 but did not participate in the recruitment process. If an eligible patient agreed to participate, then the staff obtained written informed consent and scheduled the baseline assessment, which was to be conducted in English or Spanish, depending on patient preference. The patients were stratified by minority group and randomly assigned to the intervention group or the control group by an electronic protocol management system. The Institutional Review Boards of The University of Texas MD Anderson Cancer Center and the Harris Health System approved the study. IVR Intervention
The IVR system was demonstrated at baseline to patients in the intervention group, who then practiced using the system. The research staff explained that the system would call 2 times per week for 8 weeks at preferred times. The system asked patients to identify themselves using a study number, and then the IVR symptom script began. Patients reported their responses using the touch-tone telephone keypad. If a patient did not have telephone access during the study, then a cell telephone was provided. If a patient did not answer an IVR call, then the system Cancer
June 1, 2015
repeated the call up to 3 times on the same day, spaced 45 minutes apart. If the calls were not answered, then the system notified the research staff, who contacted the patient by telephone and verbally administered the symptom items.18 The IVR intervention consisted of: 1) assessment of patients’ pain and related symptoms, 2) determination of pain or other symptoms that exceeded a severity threshold, 3) feedback of information about suprathreshold symptoms to the physician, and 4) assessment of patientrelated barriers. The barriers assessed included: 1) nonadherence to analgesic medications; 2) difficulty obtaining analgesic medications; 3) side effects from medications; 4) concerns about opioids, such as fear of addiction; 5) reliance on alternative strategies (eg, herbs) for pain management; and 6) lack of family support for pain management. When a patient reported a barrier, a member of the research staff contacted the patient by telephone and provided educational information regarding the barrier and how to overcome it.4 A standardized English/Spanish script was used and was followed by an opportunity for questions. Pain
When the patient’s reported pain level was 5 on the scale from 0 to 10, the IVR system immediately forwarded this information by e-mail to the patient’s physician. The patients in the clinic are treated by oncology fellows who are supervised by attending oncologists. The e-mail alerts were sent to the patient’s oncology fellow, and a copy was sent to the attending oncologist. The research staff monitored the IVR alerts on a Web-based intranet site and sent an e-mail to the physician who received the alert that contained a form for documentation of response. Other symptoms
The IVR assessed 12 additional symptoms contained in the MD Anderson Symptom Inventory (MDASI).19 In addition to pain, 6 symptoms (nausea, vomiting, emotional distress, sadness, drowsiness, and shortness of breath) were identified by the oncologists as symptoms that should generate e-mail alerts. The symptoms nausea, vomiting, distress, sadness, and drowsiness triggered an alert when the level was 5. For shortness of breath, the alert threshold was designated as 3. No specific thresholds were set for fatigue, sleep disturbance, lack of appetite, dry mouth, difficulty remembering, or numbness/ tingling. The physicians were provided with the intervention group’s most recent IVR symptom ratings before the patients’ clinic visits. 1883
Original Article Control Group
Patients in the control group received the usual pain and symptom management interventions given by the clinic physicians. The patients completed the paper-and-pencil assessments at baseline and at 2 follow-up assessments. They were informed that their symptom data would be used for research purposes only and would not be provided to their clinicians. All patients were instructed to report any symptoms to their physicians. Outcomes Assessment
The outcome measures were administered to all patients in the study during clinic visits at time point 1 (4-6 weeks after enrollment in the study) and at time point 2 (8-10 weeks after enrollment). Instruments MDASI. The MDASI contains 13 symptom items that are rated from 0 to 10 on numeric scales. The reliability and validity of the MDASI have been demonstrated.19,20 The Spanish language version of the MDASI has been validated.21
The Barriers Questionnaire II (BQ-II) was developed to measure patient beliefs that are barriers to optimal pain treatment. The BQ-II has demonstrated excellent reliability and validity.22-24 The Spanish language version of the questionnaire has been validated.25 Barriers Questionnaire-II.
Other measures
The Eastern Cooperative Oncology Group performance status scale was used to assess the physician’s estimate of the patient’s functional status at baseline.26 This scale is an observational measure of functional ability that has demonstrated excellent reliability and validity.27,28 Performance status.
Biomedical variables. Biomedical information was recorded from the patients’ electronic medical records. Pain management index. The analgesic data were used to compute a pain management index (PMI) score at each assessment.29 Pain management is considered adequate when there is congruence between the patient’s pain severity and the appropriateness of the prescribed analgesic. Negative PMI scores indicate under-medication, and scores 0 are considered a conservative indicator of acceptable treatment. Patient demographic form. Patients completed a demographic questionnaire, which included questions about age, race, and ethnicity.
1884
The feasibility of the intervention was evaluated by determining rates of recruitment and retention, patient adherence to the call schedule, rates of physician receipt and response to the alerts, and physician evaluation of the IVR system.
Feasibility measures.
Statistical Analysis
For this pilot study, we planned to enroll a total of 60 patients. Our objectives were to pilot the intervention, obtain an estimate of its effect, and collect feasibility measures. Our power analysis indicated that we could detect a standardized difference of 0.74 in mean pain severity ratings between the the control and intervention groups using a 2-tailed test at an a level of. 05 and. 80 power. We used descriptive statistics to describe how patients rated pain and symptom severity. Proportions of patients who rated their symptoms as moderate to severe (5 on a 0-10 scale) were reported.30 Potential differences between patient groups based on demographic variables were explored using chi-square tests or t tests. If the normality assumption was not met for the t test, then the Wilcoxon test was used. Nominal P values were reported. To evaluate the effectiveness of the IVR intervention, linear mixed models were used to evaluate changes in mean pain and symptom severity across time. A groupby-time interaction term was included in each model. In addition, a random intercept was included to account for baseline variations in pain and symptom severity. Performance status and PMI scores were entered as covariates to control for possible effects of function and pain management. The PMI score was not included in the model for pain severity. Generalized estimating equation analysis was used to determine the likelihood of observing a higher number of symptom threshold events in the intervention group. To address our hypothesis that the severity of pain would be reduced in the intervention group, we used the McNemar test to compare the proportions of patients with moderate to severe pain across time. In addition, we calculated the PMI score for each patient and performed a chi-square test to compare the proportions of patients whose pain was inadequately managed in the IVR and control groups. To address our hypothesis that the severity of pain-related symptoms, such as sleep disturbance and emotional distress, would be reduced in the intervention group, we used linear mixed models to compare painrelated symptoms between the IVR and control groups. The McNemar test was used to compare the proportions of patients with moderate to severe symptoms across time. Cancer
June 1, 2015
Breast Cancer Pain Intervention/Anderson et al
Figure 1. This Consolidated Standards of Reporting Trials (CONSORT) flow diagram illustrates patient flow throughout the study.
Secondary Analyses
We used the t test or its nonparametric counterpart to compare BQ-II scores between the groups at baseline and at time point 1, and between the groups at baseline and at time point 2. The primary endpoints for the evaluation of feasibility were the recruitment and retention rates; and secondary variables were patient adherence to the symptom assessment, frequency of alerts and responses to alerts, and physician evaluation of the intervention. RESULTS Patient Characteristics
Of the 449 patients with breast cancer who were screened for eligibility, 73 patients were eligible and were approached regarding participation in the study (Fig. 1), and 60 patients agreed to be enrolled. Reasons for refusal included lack of time (n = 2), reluctance to complete questionnaires (n = 2), financial concerns (n = 1), lack of interest (n = 1), and unknown (n = 7). Eighty-four percent of the intervention group and 72% of the control group completed the first follow-up assessment, and 68% of the Cancer
June 1, 2015
intervention group and 86% of the control group completed the second follow-up assessment. Demographic and clinical characteristics of the 60 participants are listed by group assignment in Table 1. The mean 6 standard deviation time since cancer diagnosis was 2.0 6 3.3 years, with no significant differences between groups. No significant baseline differences were observed between the intervention and control groups or between African American and Latina women, between younger women versus older women, or by disease stage. Most patients were receiving active treatments, but 16 patients (27%) had recently finished treatment or were waiting for treatment to begin. Among the Latina patients, 74% described Spanish as their primary language. Symptom Alerts
During the study, 71% of the IVR assessments were completed successfully. In total, 221 symptom alerts were generated for patients in the intervention group for pain (n = 164), drowsiness (n = 140), emotional distress (n = 109), 1885
Original Article TABLE 1. Baseline Demographic and Disease Variables Among African American and Latina Women With Breast Cancer No. of Patients (%)
Characteristic Age: Mean 6 SD, y Education: Mean 6 SD, y Ethnic group African American Latina Marital status Married Unmarried Employment status Unemployed Employed Homemaker Retired Other Disease stage IIA-IIB IIIA-IIIB IV Unknown Disease status No evidence of disease Local/regional Metastatic Unknown Treatment status Chemotherapy Radiotherapy Hormone therapy Immunotherapy Noneb Patients with severe painc Good performance statusd
Intervention Group, n = 31
Control Group, n = 29
49.6 6 9.9 10.6 6 4.1
50.5 6 11.0 10.0 6 2.9
13 (42) 18 (58)
12 (41) 17 (59)
15 (48) 16 (52)
13 (45) 16 (55)
16 (52) 2 (6) 7 (23) 4 (13) 2 (6)
15 (52) 4 (14) 8 (28) 2 (7) 0 (0)
7 (23) 11 (35) 11 (35) 2 (6)
7 (24) 12 (41) 10 (34) 0 (0)
4 (13) 14 (45) 11 (35) 2 (6)
4 (14) 12 (41) 12 (41) 1 (3)
14 (45) 1 (3) 5 (16) 2 (6) 9 (29) 21 (68) 14 (45)
17 (59) 0 (0) 3 (10) 2 (7) 7 (24) 23 (79) 15 (45)
Pa .76 .51 .97
.78
.31
.91
.91
.44
Differences in pain severity
Linear mixed models for mean pain scores on the MDASI revealed a significant time effect (P
