Objective: To assess whether a self-care toolkit (SCT) provided to breast cancer patients undergoing surgery could mitigate distress and lessen symptoms associated with surgery.Design: One hundred women with breast cancer, planning to undergo initial surgery, were randomly assigned to either one of two groups: treatment as usual (TAU; n = 49) or TAU with the addition of an SCT (n = 51). The SCT contained an MP3 player with audio-files of guided mind–body techniques (breathing, progressive muscle relaxation, meditation, guided imagery, and self-hypnosis) and acupressure antinausea wristbands. Anxiety, pain, nausea, sleep, fatigue, global health, and quality of life (QOL) were assessed using validated outcome measures. Two inflammatory blood markers (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]) were measured serially. Data were collected at baseline (T1), immediately before surgery (T2), within 10 h postoperatively (T3), and ∼2 weeks postsurgery (T4).Settings: Numerous studies have shown that psychological distress associated with a cancer diagnosis can affect pain perception and QOL.Results: Between T1 and T4, there were significant between-group differences in Patient-Reported Outcomes Measurement Information System (PROMIS)-57 scores of Pain Interference, Fatigue, and Satisfaction with Social Roles, favoring the SCT group compared with TAU (p = 0.005, p = 0.023, and p = 0.021, respectively). There was a significant mean change in Defense and Veterans Pain Rating Scale (DVPRS) scores from T2 to T3, with the SCT group having significantly smaller increases in postoperative pain (p = 0.008) and in postoperative ESR (p = 0.0197) compared with the TAU group. Clinically significant reductions in anxiety occurred in the SCT group during the main intervention period.Conclusion: These results suggest that using the SCT in the perioperative period decreased pain perceptions, fatigue, and inflammatory cytokine secretion.
BackgroundThe present investigation tested the efficacy of the Tennant Biomodulator, a novel pain management intervention that uses biofeedback-modulated electrical stimulation, to reduce chronic pain and its psychosocial sequelae in a sample of current and former military service members. The Tennant Biomodulator used on its most basic setting was compared to two commonly used, non-pharmacological pain treatments—traditional Chinese acupuncture and transcutaneous electrical nerve stimulation (TENS)—in a comparative efficacy, randomized, open-label trial.MethodsParticipants included 100 active duty and retired service men and women with chronic pain undergoing treatment at the Brooke Army Medical Center in Texas, USA, randomly assigned to receive six, weekly sessions of either Tennant Biomodulator treatment, traditional Chinese acupuncture, or TENS, in addition to usual care. Recruitment was conducted between May 2010 to September 2013. Outcome measures were collected at intake, before and after each treatment session, and at a 1-month follow-up. Intent-to-treat analyses were used throughout, with mixed models used to investigate main effects of group, time, and group × time interactions with consideration given to quadratic effects. Outcomes measured included ratings of chronic pain, pain-related functional disability, and symptoms of post-traumatic stress disorder (PTSD) and depression.ResultsOn average, regardless of their treatment group, participants exhibited a 16% reduction in pain measured by the Brooke Army Medical Center’s Clinic Pain Log [F(1, 335) = 55.7, P < 0.0001] and an 11% reduction in pain-related disability measured by the Million Visual Analog Scale [MVAS: F(1, 84) = 28.3, P < 0.0001] from baseline to the end of treatment, but no one treatment performed better than the other, and the reductions in pain and pain-related disability were largely lost by 1-month follow-up. Symptoms of PTSD and depression did not change significantly as a function of time or group.ConclusionsFindings build on previous work suggesting that traditional Chinese acupuncture and TENS can reduce pain and its functional sequelae without risks associated with pharmacological pain management. The Tennant Biomodulator used on its most basic setting performs as well as these other interventions. Based on the present findings, large, randomized controlled trials on the Tennant Biomodulator are indicated. Future work should test this device using its full range of settings for pain-related psychological health.Trial registrationClincialtrials.gov (NCT01752010); registered December 14, 2012.
More than one third of women diagnosed with breast cancer experience significant emotional distress, which may then effect pain perception, wound healing, quality of life (QOL), and return to physical function. Several studies have shown that physical and cognitive relaxation strategies may relieve perioperative anxiety, leading to improved postoperative pain and QOL. One hundred women from Brooke Army Medical Center with non-metastatic breast cancer, planning to undergo surgery as initial treatment, were randomly assigned using an intention-to-treat model to either the treatment as usual group (TAU; n = 49) or TAU plus a self-care toolkit (SCT; n=51). The SCT included audio-recordings of guided mind-body techniques (breathing, progressive muscle relaxation, meditation, guided imagery, and self-hypnosis), an acupressure anti-nausea wristband, and a workbook with instructions for use of the tools plus a section to journal the cancer experience. Pain, anxiety, nausea, sleep, fatigue, global health, and QOL were assessed using the Defense and Veterans Pain Rating Scale (DVPRS), the 10-cm Visual Analog Scale (VAS), and the NIH PROMIS-57 subscales. Data was collected at baseline (T1), immediately prior to surgery (T2), within 10 hours post-operatively (T3), and approximately two weeks post-surgery (T4). Two inflammatory blood markers (ESR and CRP) were measured at T1, T2, and T4. Due to diurnal variability of ESR and CRP, laboratory draws were generally collected prior to 10:00 AM. Categorical variables and frequency counts were analyzed using Chi-Squared or Fisher's Exact tests, whichever was most appropriate. Means and standard deviations were used as summary statistics for continuous variables and analyzed using Student's t-test, ANOVA, and/or Wilcoxon's Test. For data measured at two time points, the delta change in values was calculated to detect within-group differences in SCT and TAU using Wilcoxon's rank sum test or paired t-test. For factors measured at more than two time points, a two-way repeated measures ANOVA was implemented with a Bonferroni corrected post-hoc analysis to determine between-group differences at each time point. Between T1 and T4, there were significant between group differences in PROMIS-57 scores of Pain Interference, Fatigue, and Satisfaction With Social Roles, favoring the SCT group compared to TAU (p=0.005, p=0.023, and p=0.021, respectively). There was a significant mean change in DVPRS scores from T2 to T3, with the SCT group having significantly smaller increases in post-operative pain (p=0.008) and in post-operative ESR (p=0.0197) compared with the TAU group. Clinically significant reductions in anxiety occurred in the SCT group during the main intervention period. These results suggest that using the SCT in the perioperative period decreased pain perceptions, fatigue, and inflammatory cytokine secretion. The view(s) expressed herein are those of the author(s) and do not reflect the official policy or position of Brooke Army Medical Center, the U.S. Army Medical Department, the U.S. Army Office of the Surgeon General, the Department of the Army, the Department of the Air Force and Department of Defense or the U.S. Government. Citation Format: Setlik RF, Inman A, Peacock K, Aden J, Paat C, Stoerkel E, Bellanti D, Walter J. Pilot project assessing the impact of self-care techniques on post-surgical pain, fatigue, and inflammation [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr PD6-03.
Background: Breast cancer is the leading cancer among women of Hispanic origin. It is expected to continue to be the leading cancer as the US Hispanic population grows towards 31% of all US citizens by 2060. Hispanic women (Latinas) experience significant disparities in breast cancer services resulting in lower breast cancer survival rates than the general population after accounting for differences in age, cancer stage and other factors. Root- causes of disparities are multifactorial, including diagnostic and treatment delays, language, social, and financial barriers, and poor communication between patients and health care providers. Patient navigation (PN) is a potential intervention to address cancer disparities. We conducted “Staying Healthy,” a two-year, two-arm randomized controlled trial testing the effectiveness of a PN intervention to increase Latinas' access to cancer screening, diagnosis and care. Methods/Design: Staying Healthy is a Susan G. Komen for the Cure-sponsored randomized controlled trial (RCT) of PN targeting Latina breast cancer survivors (BCS). The goal is to develop a model of PN that will eliminate cancer care disparities in Latinas by addressing barriers to cancer care and promoting patient self-efficacy. The intervention uses trained navigators from the target community. Participants are randomly assigned to receive either usual PN services or intervention (PN+) services. In addition to usual participant-initiated PN services, PN+ participants receive tailored educational materials, regular personalized assistance including phone calls, meetings, and coordination of targeted care. Dependent measures include compliance with health care recommendations, screening practices and general and breast cancer-specific quality of life (QOL). Results: Baseline analyses have been performed on 120 enrolled participants. Results indicate 57% had Medicare or Medicaid insurance coverage; they average 57.3±9.5 years of age; 38% are Spanish monolingual, 58% US born, 47% are married or living together and 87% are parents. Additionally, more than three-fifths (61%) report an annual income below $25,000. They are 3.6±2.8 years post-diagnosis and 3.2±2.6 years post-primary treatment. Finally, study participants report general health-related (Functional Assessment of Cancer Therapy-General, FACT-G: 82±16.8) and breast cancer-specific QOL (FACT-B: 107±21.4). Lower levels of distress are significantly correlated with higher QOL measures after controlling for the effects of age, time since primary treatment, and acculturation. Discussion: Results show that levels of distress and QOL are inversely associated independently of other factors such as age, time since primary treatment and degree of acculturation. Interventions to reduce cancer health disparities may be an effective approach for patient navigation. Citation Format: Amelie G. Ramirez, Edgar Muñoz, Erika L. Stoerkel, Amanda Sintes-Yallen, Alan E.C. Holden. Study protocol: A randomized controlled trial of patient navigation to reduce cancer health disparities in Latina breast cancer survivors. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr C22.
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