Running head: CHRONIC PAIN IN BREAST CANCER PATIENTS Chronic Pain in Breast Cancer Patients Ashlee Feyes, Student Nurse University of South Florida 1 CHRONIC PAIN IN BREAST CANCER PATIENTS 2 Abstract Pain is a chronic occurrence in patients with breast cancer, and the effects can range anywhere from feeling uncomfortable to depression from severe pain. The goal of this project is to decrease the levels of pain in patients with breast cancer through the use of pharmacological methods as well as acupuncture for a three-month trial period. This paper explores four articles found through search engines CINAHL, PubMed, and FindIt at USF. Key terms included: breast cancer, acupuncture, pain management, complementary medicine, alternative medicine, Aromatase Inhibitors, joint pain and stiffness. Results of the studies showed that acupuncture as an adjunctive therapy for pain decreased pain rates significantly, and therefore should be used to decrease the rates of chronic pain in breast cancer patients. After researching and synthesizing the evidence, a pilot study will be performed on the oncology unit using the Iowa Evidence Based Practice model. Results will be evaluated through the Visual Analogue Scale (VAS) for pain after three-months of acupuncture co-treatment. CHRONIC PAIN IN BREAST CANCER PATIENTS 3 Chronic Pain in Breast Cancer Patients According to Smith & Wu, one debilitating issue that breast cancer treatment survivors suffer is persistent pain after breast cancer treatment (PPBCT) (2012). This side effect of chronic pain is so common, it is shown in 50% of breast cancer survivors (Smith, 2012). Breast cancer patients are treated with pharmacological methods to relieve pain, but there would be better pain control if they were treated with both pharmaceuticals and alternative therapies, such as acupuncture. Decreasing the rate and severity of pain will lead to an increase in patient satisfaction, better patient outcomes, compliance with medications and shorter hospitalizations. The initial clinical question for this project is: In breast cancer patients with pain symptoms, how does the use of a combination of acupuncture and pharmacological methods compared to the use of pharmacological methods alone affect rates of pain in three months? Infrastructure necessary for this project is to recruit women with breast cancer who are using aromatase inhibitors and are having chronic back pain due to these medications to combat the breast cancer. There will also need to be oncology nurses, who will be responsible for measuring and recording pain before and after acupuncture treatments, as well as administering any pharmacological interventions for pain in the control group. Another member of the team will be an acupuncturist, who is responsible for administering acupuncture to patients in need. This project may be implemented in oncology clinics, pain management clinics, hospitals, and outpatient facilities. The culture at St. Joseph’s hospital is very open to EBP, and is willing to run a pilot study and adopt the method of practice if positive results are seen. This topic is a priority for the organization because the main goal is patient satisfaction, and decreased pain rates will increase patient satisfaction scores. Research, Review, and Synthesize CHRONIC PAIN IN BREAST CANCER PATIENTS 4 Literature Search During the research phase, there were multiple search engines used. Research began with CINAHL and PubMed, and finished by using FindIt on the USF library website EBSCO host. Key terms used included “chronic pain,” “breast cancer,” “acupuncture,” “cancer,” and “back pain.” Multiple searches were performed, and those with relevant beneficial results were extracted. After retrieving the most relevant sources for chronic breast cancer pain and acupuncture therapy, we shifted our research focus to articles with chronic lower back pain and acupuncture therapy. Literature Review In Crew et al. (2010), the study was performed to determine if true acupuncture, when compared to sham acupuncture, resulted in decreased rates of pain in patients with musculoskeletal pain symptoms due to AI use. This study consisted of 51 women with breast cancer, who were on aromatase inhibitors (AI) that were causing joint pain and stiffness. These women were enrolled in true acupuncture (TA) over their full body or sham acupuncture (SA), which was in non-acupoint locations. Patients were allowed to use NSAIDS and nonnarcotic medications during the sessions. Pain was scored on a Brief Pain Inventory-Short Form (BPISF), which compared pain severity (0-10) and the effects on the patient’s daily life. Using this scale from baseline, pain was lower in TA versus SA after six weeks (p<0.001). Refer to Table 1 for additional source information. The greatest strength of this study was that it was a double blind study. Another strength is having most women in early stages of breast cancer (12 in stage 1 for each in TA and SA group). Weaknesses include a small sample size, and different uses of AI therapy (anastrozole, letrozole, and examestane). This study was also done over six weeks, CHRONIC PAIN IN BREAST CANCER PATIENTS 5 which fits into our three-month time frame. This study shows that patients who receive true acupuncture have a greater reduction in pain versus the control group. In Mao et al. (2014), the study was performed to determine if rates of pain in breast cancer patients on AIs were decreased through the use of electro-acupuncture or sham acupuncture. This study consisted of 67 breast cancer patients who were having joint pain and stiffness due to AI use. These patients were randomly assigned to electro-acupuncture (EA) and sham acupuncture (SA) treatments over eight weeks. Pain was rated on the Brief Pain Inventory (BPI) scale. Over eight weeks, the EA group had a reduction in pain severity of 2.2 and SA had a decrease of 2.3 (p=0.0004). The real surprise came from reassessing the patients at twelve weeks to see if the acupuncture had lasting effects; the EA group had a reduction of pain by 2.4, and the SA group had a reduction by 1.7 (p<0.0001). Compared to baseline, EA produced a 43.1% reduction in pain severity and 52.6% reduction in pain-related life interferences (see Table 1). Strengths of this study include that it is double blind, and showed there was an increase in pain reduction through the use of acupuncture. One weakness of this study was that the sham acupuncture group had more pain relief over the eight weeks. This study shows that electroacupuncture does relieve pain in breast cancer patients using AI therapy. In Yun et al. (2012), the study was performed to determine if Hegu acupuncture or standard acupuncture would decrease the rates of pain in patients with chronic back pain versus the control group over eight weeks, and to see the lasting effects of acupuncture over 48 weeks. This study was performed on 187 patients with chronic low back pain (CLBP). Patients were 2045 years old, and must have presented with back pain for at least three months prior to the study. The study separated patients into Hegu acupuncture (acupuncture on the hand), standard acupuncture, or the usual care (control) group. Measurements were performed through the CHRONIC PAIN IN BREAST CANCER PATIENTS 6 Roland-Morris Disability Questionnaire (RMDQ), which shows the level of disability due to the back pain, and the Visual Analogue Scale (VAS), which assesses pain intensity. Patients were assessed using these tools at baseline, after eight weeks, and again 48 weeks later to see the duration of pain relief. Over eight weeks, RMDQ mean scores in the Hegu group were 5.7, standardized was 6.6, and usual care was 8.8 (p<0.001). Also over these eight weeks, the VAS scale in Hegu was 4.6, in standardized was 5.0, and usual care was 5.6 (p<0.001). Refer to Table 1 for additional source information. The randomization of patients strengthens this study, since this minimizes bias and helps to assure that groups are similar. The study also utilized a valid and reliable measure of pain (e.g. VAS). Another strength is the ample amount of follow-up time (48 weeks), which provided enough time to measure the lasting effects of acupuncture. Another strength of this study includes it being a double blind, sham controlled study. Enrolling those who have had low back pain for at least three months prior, and excluding those with complicated back issues (scoliosis/sciatica) and those who have had prior acupuncture treatments for any condition were a few other strengths of this study (Yun et al., 2012). A weakness of this study is that pain scores did not see a significant change over the course of the study during the initial eight-week trial, however there was a difference after the 48-week reevaluation. This study shows how acupuncture relieves chronic pain, which cancer patients deal with daily. In Weib et al. (2013), the study was performed to determine if acupuncture would decrease the rates of pain and increase the quality of life in patients with chronic back pain. This study consisted of 160 patients with CLBP, who were recruited from an inpatient rehabilitation program and randomized into two treatment groups. Each group consisted of 80 participants, who either received acupuncture interventions, or acted as part of the control group. Effectiveness was measured through patient surveys (Short-form 36) on their health related CHRONIC PAIN IN BREAST CANCER PATIENTS 7 quality of life, which included pain quality, intensity, and duration. Upon a three-week posttreatment versus prior to treatment review of the Short-form 36, patients showed an increase in physical functioning (p=0.02), vitality (p<0.01), social functioning (p=0.08), and emotional roles (p=0.05). Bodily pain scores decreased three weeks post-treatment as well (p=0.28) (see Table 1). Strengths of this study include the randomization of patients, patient diversity, and a large population size (160 patients). Another strength is the results show that acupuncture does benefit the patients with minimal to no adverse effects on those without a prior clotting or platelet disorder. Weaknesses include only being able to follow up on 143 patients out of the total enrolled 160, use of a quality of life form instead of an actual pain rating scale, and inability to distinguish patients reasoning for back pain or prior treatments tried. This study shows that acupuncture has pain relieving capabilities in correlation with rehabilitation for patients living with chronic lower back pain or musculoskeletal system, which is something most cancer patients deal with daily. Synthesis All of the above mentioned studies are similar in their outcomes, which is that acupuncture is an effective treatment option for pain. Another similarity is that Crew et al. (2010) and Mao et al. (2014) include women with breast cancer who are receiving acupuncture therapy to relieve joint pain and stiffness due to AI medication usage, and also use the same measurement scale for pain (BPI and BPI-SF). Likewise, the other two studies from Weib et al. (2013) and Yun et al. (2012) include both women and men who have chronic low back pain and receive acupuncture therapy for the treatment of this musculoskeletal disorder. Differences include sample sizes, types of acupuncture used, length of treatment, and number of treatments during the specified length in weeks (Refer to Table 1). CHRONIC PAIN IN BREAST CANCER PATIENTS 8 Key pieces from each study are necessary to develop this project. Crew et al. (2010) shows that women receiving true acupuncture for six weeks alleviate more pain than use of NSAIDs or non-narcotic pain medication alone (p<0.001). Mao et al. (2014) shows that women receiving electro-acupuncture for eight weeks also show a decreased pain score after the eight weeks (p=0.004), as well as having a lasting pain decrease when reassessed after twelve weeks (p<0.0001). The next two studies involve chronic low back pain, which can be related to the incidence of joint pain and stiffness in breast cancer patients. Weib et al. (2013) shows that acupuncture in conjunction with rehabilitation over a three-week period alleviates more pain than those without acupuncture treatments. Lastly, Yun et al. (2012) shows that Hegu (or hand) acupuncture over eight weeks alleviates more pain versus sham acupuncture or no acupuncture on both the RMDQ and the VAS for pain (p<0.001). Through this knowledge, it can be inferred that acupuncture is a reliable treatment option to alleviate musculoskeletal pain in breast cancer individuals. However, further studies must be conducted to determine the lasting effects of acupuncture with reference to pain scores, which acupuncture works best for musculoskeletal pain (TA/EA/Hegu acupuncture), as well as any possible side effects, and how patients who cannot undergo acupuncture treatments will receive pain relief. Practice Change Proposal Clinical recommendations for our clinical setting and population are to decrease the rate and severity of pain, which will lead to an increase in patient satisfaction, better patient outcomes, greater compliance with medications and shorter hospitalizations. These recommendations will be achieved by allowing breast cancer patients to receive a combination therapy of pain medications, rehabilitation and true acupuncture. An acupuncturist will perform ten, forty minute treatments, of true acupuncture over eight weeks time. The nurse will evaluate CHRONIC PAIN IN BREAST CANCER PATIENTS 9 pain before and after each treatment for the eight weeks, then again through a phone survey four weeks post-treatment. Oncology nurses will have core measures for patients with breast cancer to receive acupuncture along with their scheduled pain medication. Strategy Change As a result of this new evidence, this topic has become a priority. Through synthesis of the evidence, and adequate information, a pilot change will be conducted on the oncology unit. Strategies to promote staff/team engagement include thorough education for staff and a resource individual to answer any questions the staff may have about the newly placed core measures. There will also be a Frequently Asked Questions (FAQ) sheet placed on the bulletin boards of the oncology units. This sheet will state evidence reflecting the combination use of pharmaceuticals and acupuncture to treat chronic musculoskeletal pain for breast cancer individuals. Lastly, there will be a goal chart online, which will state the three-month timeline and show the progression towards the goal through numbers of patients, numbers of acupuncture treatments, and pain ratings among patients. Once the practice change reaches its’ three-month trail, results should show that pain scores were decreased by at least 2/10 levels. We will be using the IOWA EBP implementation model for the pilot study. Roll Out Plan and EBP Process Identifying Triggers: Pain management is the goal of every nurse, although it can be difficult to manage chronic pain. Acupuncture as a co-treatment for pain management is a new topic of priority. The issue was identified through thorough research, and occurred in January 2015. Gathering and Synthesizing evidence: A team was developed to gather evidence, and new research showed that chronic back pain, as well as joint pain and CHRONIC PAIN IN BREAST CANCER PATIENTS 10 stiffness, can be relieved at higher rates through acupuncture in conjunction with pharmacological pain management methods. This research took place between January and February of 2015. Pilot change: A pilot change will be conducted beginning in April and continue until the end of June 2015, which will follow core measures for acupuncture and pharmacological methods to decrease pain in breast cancer patients. Implementation and evaluation of results will occur during this three-month trial. Dissemination of Evidence: If there is a result of decreased pain ratings in patients who receive acupuncture as a combination therapy with usual care treatments, this practice change will be implemented throughout the hospital for any breast cancer patient, the evidence will be written into the Journal of Complementary and Alternative Medicine, and it will be suggested in a board meeting with Moffitt Cancer Center in August 2015. Project Evaluation Pain will be measured using a 0 – 10 VAS scale. Patients will be assessed at baseline, and reevaluated at the end of the three-month acupuncture therapy. Mean scores will be compared to evaluate the effectiveness of the practice change. The goal of the project is to decrease pain levels by at least two points (mean values) on the VAS. For example, if the mean value at the beginning is eight, and after three-months the mean value is seven, the goal was not met, and the study will be deemed unsuccessful. If the beginning value is eight, and the ending mean value is four, the study will be highly successful, and may proceed to a second phase in which the lasting effects of acupuncture will be evaluated six-months post-treatment. Data collection will be CHRONIC PAIN IN BREAST CANCER PATIENTS 11 performed through nurse evaluation or surveys sent to the patients’ homes (for those who opt for outpatient treatments). Dissemination of EBP As mentioned above, the first step will be to implement the core measures throughout the hospital for any breast cancer patient. Next, a meeting will be arranged with the clinical specialists at Moffitt Cancer Center to discuss the evidence, the results of the pilot project, and to suggest implementation throughout the facility. Also, the evidence will be submitted to the Journal of Complementary and Alternative Medicine to distribute regionally in hopes of improving patient outcomes throughout the US. Lastly, there will be a documentary on the Discovery Channel of women who would like to participate while going through the acupuncture treatments. CHRONIC PAIN IN BREAST CANCER PATIENTS 12 References Crew, K., Capodice, J., Greenlee, H., Brafman, L., Fuentes, D., Awad, D., ... Hershman, D. (2010).Randomized, blinded, sham-controlled trial of acupuncture for the management of aromatase Inhibitor-associated joint symptoms in women with early-stage breast cancer. Journal of Clinical Oncology, 28(7), 1154-1160. doi:10.1200/JCO.2009.23.4708 Mao, J. J., Xie, S. X., Farrar, J. T., Stricker, C. T., Bowman, M. A., Bruner, D., & DeMichele, A. (2014). A randomised trial of electro-acupuncture for arthralgia related to aromatase inhibitor use. European Journal Of Cancer, 50(2), 267-276. doi:10.1016/j.ejca.2013.09.022 Smith, H. & Wu, S. (2012). Persistent pain after breast cancer treatment. Annals of Palliative Medicine. 1(3), 182-194. doi: 10.3978/j.issn.2224-5820.2012.10.13 Weib, J., Quante, S., Xue, F., Muche, R., & Reuss-Borst, M. (2013). Effectiveness and acceptance of acupuncture in patients with chronic low back pain: Results of a prospective, randomized, control trial. Journal of Alternative & Complementary Medicine, 19(12), 935-941. Yun, M., Shao, Y., Zhang, Y., He, S., Xiong, N., Zhang, J., ... Yan, J. (2012). Hegu acupuncture for chronic low-back pain: A randomized controlled trial. Journal Of Alternative & Complementary Medicine, 18(2), 130-136. doi:10.1089/acm.2010.0779 CHRONIC PAIN IN BREAST CANCER PATIENTS 13 Table 1 Review of the Literature Reference Aims Design and Measures Sample Crew, K., Capodice, J., Greenlee, H., Brafman, L., Fuentes, D., Awad, D., ... Hershman, D. (2010). Randomized, blinded, shamcontrolled trial of acupuncture for the management of aromatase Inhibitorassociated joint symptoms in women with earlystage breast cancer. Journal of Clinical Oncology, 28(7), 1154-1160. doi:10.1200/JCO.2 009.23.4708 Mao, J. J., Xie, S. X., Farrar, J. T., Stricker, C. T., Bowman, M. A., Bruner, D., & DeMichele, A. (2014). A randomised trial of electroacupuncture for arthralgia related to aromatase inhibitor use. European Journal Of Cancer, 50(2), 267-276. doi:10.1016/j.ejca. 2013.09.022 Purpose: compare true acupuncture to sham acupuncture for results of decreased pain rates Women were enrolled in true acupuncture (TA) over their full body or sham acupuncture (SA). Patients were allowed to use NSAIDS and nonnarcotic medications during the sessions. Six weeks total, 30-minute treatments twice a week. Brief Pain Inventory-Short Form (BPI-SF). 51 women with breast cancer, which were currently taking Aromatas e Inhibitors . Purpose: compare eletroacupuncture to sham acupuncture for results of decreased pain rates. Patients were randomly assigned to either electro-acupuncture (EA) or sham acupuncture (SA) treatments. Ten thirtyminute treatments over eight weeks Twice a week for the first two weeks, then once a week for the remaining six weeks. 2Hz 67 patients with breast cancer, which were having joint pain and stiffness due to AI use. Outcomes / statistics Of the 51 women, only 38 were evaluable in the end. Pain was scored on a Using this scale from baseline; pain was lower in TA versus SA after six weeks (p<0.001). At baseline, TA patients had a mean pain score of 6.70, and SA patients scored 5.61. After six weeks, the mean pain score for TA patients was 3.00, and SA patients scored 5.50. After four weeks, EA patients had a decrease in pain severity by 1.7 and SA had a decrease in pain severity by 1.5. Over eight weeks, the EA group had a reduction in pain severity of 2.2 and SA had a decrease of 2.3 (p=0.0004). Patients were reassessed at twelve weeks to see if the acupuncture had lasting effects; the EA group had a CHRONIC PAIN IN BREAST CANCER PATIENTS Weib, J., Quante, S., Xue, F., Muche, R., & Reuss-Borst, M. (2013). Effectiveness and acceptance of acupuncture in patients with chronic low back pain: Results of a prospective, randomized, control trial. Journal of Alternative & Complementary Medicine, 19(12), 935-941. electrostimulatio n by a Transcutaneous Electrical Nerve Stimulation (TENS) unit in the EA sample No electrostimulatio n in SA sample. Brief Pain Inventory (BPI) scale Purpose: Patients were determine if randomized into two acupuncture treatment groups. Each decreases group consisted of 80 the rates of participants, who either pain and received acupuncture increases interventions, or acted the quality as part of the control of life in group. patients 21-day inpatient with chronic rehabilitation back pain. program for back pain. Those in the intervention group received acupuncture twice a week for three weeks in addition to the rehabilitation. Effectiveness was measured through patient surveys (Shortform 36) on their health related quality of life, which included pain quality, intensity, and duration. Inclusion criteria 14 160 patients with Chronic Low Back Pain (CLBP), recruited from an inpatient rehab program. reduction of pain by 2.4, and the SA group had a reduction by 1.7 (p<0.0001). Compared to baseline, EA produced a 43.1% reduction in pain severity and 52.6% reduction in painrelated life interferences. Upon a three-week post-treatment versus prior to treatment review of the Short-form 36, patients showed an increase in physical functioning (p=0.02), vitality (p<0.01), social functioning (p=0.08), and emotional roles (p=0.05). Bodily pain scores decreased three weeks post-treatment as well (p=0.28). CHRONIC PAIN IN BREAST CANCER PATIENTS Yun, M., Shao, Y., Zhang, Y., He, S., Xiong, N., Zhang, J., ... Yan, J. (2012). Hegu acupuncture for chronic low-back pain: A randomized controlled trial. Journal Of Alternative & Complementary Medicine, 18(2), 130-136. doi:10.1089/acm.2 010.0779 included chronic low back pain for at least six months prior, and age range between 25-75 years old. Exclusion criteria included anticoagulation therapy, coagulation disorders, thrombocytopeni a, poor understanding of the German language, recent surgeries, or any herniation of spinal disks. Purpose: The study separated determine if patients into Hegu Hegu acupuncture acupuncture (acupuncture on the versus hand), standard standard acupuncture, or the acupuncture usual care (control) will group. decrease the Patients per rates of pain group were: 64 in patients in Hegu, 60 in with chronic standard, and 63 back pain in control. over eight Treatments were weeks. Also every other day to see the for three weeks, lasting then twice a effects of week for four acupuncture weeks over 48 Eighteen weeks. treatments total in seven weeks. The RolandMorris Disability Questionnaire 15 187 patients with chronic low back pain (CLBP) Patients were 2045 years old and must have presented with back pain for at least three months prior to the study. Patients were assessed at baseline, after eight weeks, and again 48 weeks later to see the duration of pain relief. Over eight weeks, RMDQ mean scores in the Hegu group was 5.7, standardized was 6.6, and usual care was 8.8 (p<0.001). Also over these eight weeks, the VAS scale in Hegu was 4.6, in standardized was 5.0, and usual care was 5.6 (p<0.001). CHRONIC PAIN IN BREAST CANCER PATIENTS 16 (RMDQ): shows the level of disability due to the back pain. The Visual Analogue Scale (VAS): assesses pain intensity. (0-10)