BACKGROUND: A review of the literature identifies high levels of anxiety and depression as adverse effects of oncology diagnosis and treatment, even for patients with curable cancers such as early stage breast cancer (ESBC). Studies have reported that music therapy yields remarkable, multi-dimensional benefits on an individual's mood and state of mind. The purpose of this trial is to evaluate the impact of personalized music therapy (PMT) in reducing anxiety and other adverse mental health symptoms experienced by patients receiving chemotherapy treatment for ESBC. ELIGIBILITY: Females ≥ 18 years diagnosed with ESBC (Stage I-III) initiating intravenous chemotherapy as their only oncology treatment modality who report anxiety ≥ 4 on a numerical rating scale of 0-10. TRIAL DESIGN: This is a 4-week, two-arm, randomized (1:1) trial evaluating the anti-anxiety benefits of PMT for women with ESBC initiating intravenous (IV) chemotherapy. The patients randomized to the experimental group will participate in 30-minute PMT sessions conducted by a Licensed Musical Therapist (LMT). Initial PMT will occur within 1 hour of the patient's first chemotherapy infusion (C1D1), then once weekly for the remaining 3 weeks of the trial. Patients randomized to the control group will be referred to the medical oncologist for standard of care (SOC) anxiety treatment. Outcomes will be measured via the Generalized Anxiety Disorder Assessment (GAD-7), the Center for Epidemiologic Studies Depression Scale (CES-D), the Pittsburgh Sleep Quality Index (PSQI), and the Symptom Inventory Tool-M.D. Anderson Symptom Inventory (SIT-MDASI) to be completed by both cohorts at baseline and regular intervals for the duration of the study. AIMS: The primary endpoint is to determine the impact of PMT during chemotherapy treatment on patient reported anxiety (GAD-7). Secondary endpoints will determine the impact of PMT during chemotherapy treatment on patient reported depression (CES-D), sleep disturbances (PSQI), and quality of life (SIT-MDASI). STATISTICAL METHODS/TARGET ACCRUAL: Patients will be randomized to receive either PMT or SOC using the Pocock-Simon dynamic allocation method to balance tumor stage between the arms. With 30 patients in each arm and approximate target accrual of 60, the study achieves 80.0% power to detect a 0.65 standard deviation unit effect size of the change in scale measure between baseline and 4 weeks at the 0.05 significance level using a one-sided two-sample t-test. GAD-7 change will be compared between the two arms using a two-sample t-test (Pooled Standard error or Satterthwaite approximation as appropriate). The secondary outcomes include CES-D, PSQI, and SIT-MDASI for which a longitudinal analysis of subscale scores will be conducted using a generalized linear mixed-effects model with fixed effects for treatment group and time. All statistical analyses will be conducted using SAS 9.3 [SAS Institute Inc., Cary, NC, USA]. Statistical significance will be defined as p < 0.05. Citation Format: Toole Jr. M, Bendinger GM, Ensor Jr. JE, Alvarez Tapias C, Smith E, McGuire E, Rados K, McNight JE, Pabbathi H, Panicker R, Johnson AT, Lammersfeld C, Alvarez RH. A randomized study of personalized music therapy for patients with early stage breast cancer receiving chemotherapy [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-08-01.
Background: Cancer patients (pts) are burdened by symptoms related to the disease itself or to the toxicities of treatment. A recent meta-analysis has shown that anxiety is the most common mental health issue among cancer survivors [Mitchell AJ, 2013]. The ASCO clinical oncology guideline adaptation recommends all health care providers routinely screen for the presence of emotional distress and symptoms of anxiety from the point of diagnosis onward [Andersen BL, 2014]. Consensus-based recommendations have been published to help cancer centers meet the American College of Surgeons Commission on Cancer's accreditation requirement to screen for distress [Pirl, 2014] At our comprehensive community cancer center we perform distress screening using the M.D. Anderson Symptom Inventory (MDASI), composed of 27 questions. Pts who report moderate and severe levels of distress (≥5) on the MDASI are identified and referred for therapeutic interventions offered by the facility's integrative oncology services. Materials and Methods: The MDASI is an assessment tool that captures pts' perceived symptom burden for real-time clinical intervention, taken at the point of no intervention (baseline) and every 21 days or greater. The 27-question MDASI is comprised of the M.D. Anderson Symptom Inventory (MDASI), a validated 19-item assessment instrument, with a Symptom Inventory Tool (SIT) added by our center of 8 questions and a free-text box. Symptoms are rated “at the worst” on an 11-point numeric scale ranging from 0 (“none present”) to 10 (“as bad as you can imagine”), as experienced by the patient in the past 24 hours. Results: Over a ten-month period (9/1/2014 to 6/30/2015), 247 breast cancer (BC) pts completed the MDASI at intake and again ≥ 21 days after. Analysis of their initial surveys identified 69 pts (27.9%) who rated their distress as ≥ 5 (1st MDASI mean = 6.83), scores which would have initiated a support system response with referrals to integrative medicine services for intervention. Second MDASI results from these 69 BC pts revealed an average 2.29 distress score reduction (2nd MDASI mean = 4.48), with 51 pts (73.9%) reporting a decrease in distress, 7 pts (10.1%) having no change, and 11 pts (15.9%) reporting increased distress. More specifically, the group with decreased distress levels documented a mean distress score of 3 on their 2nd MDASI, averaging a significant 4-point diminution of distress for three-fourths of the BC pts heavily burdened by this symptom. The integrative services most utilized by these pts were Nutrition Therapy (100%), Spiritual Care (96.1%), Mind-Body Counseling (82.4%), Rehabilitation Therapy (41.2%), Acupuncture (35.3%), and Massage Therapy (35.3%). Conclusions: Distress is a relevant symptom reported by cancer pts. This study demonstrates that early intervention in BC pts using integrative oncology approaches reduced distress in 74% of cases. Citation Format: Daneker SR, Bendinger GM, Thomas JW, Smith E, Kendrick D, Hartman S, Gordon C, Barber K, Langlois C, Pabbathi H, McKnight JE, Johnson AT, Lammersfeld C, Denny D, Markman M, Alvarez RH. Efficacy of screening and treatment of breast cancer patients reporting high level of distress [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-19-05.
BACKGROUND: Observational studies have repeatedly linked obesity to increased cancer incidence, recurrence, and mortality, leading to cancer treatment guidelines that call for maintenance of a healthy body weight, regular physical activity (PA) regardless of body mass index (BMI), and modest weight loss for overweight and obese cancer survivors (CS). Despite these recommendations, newly published reports suggest that more than 70% of CS are overweight or obese, and only 1/3 engage in the recommended levels of PA. Although trials have demonstrated that energy balance (EB) interventions are feasible in CS, it has been concluded that ongoing behavioral support is needed to implement and sustain changes in weight and PA. Through the subsequent Energy Balance Research (EnBaR) the incorporation of a weight management and PA program focused on ongoing behavioral support for breast cancer survivors (BCS) as an effective method for implementation of lifestyle modifications will be investigated. TRIAL DESIGN: This is a single-arm prospective observational study investigating if implementation of an EB Program for BCS is an effective intervention for producing lifestyle behaviors. Eligible subjects must be female BCS ≥18 years with BMI ≥25 who are initiating hormonotherapy (HT) as their only oncology treatment modality. Subjects will consult with a Registered Dietitian (RD) to establish goals based on specified interventions for reducing overall BMI at the time of initiating their prescribed HT. Subjects will subsequently receive telephone calls from the RD at bi-monthly intervals to discuss the established points of intervention, answering questions proposed by the RD from a set intervention measurement scale. Patients will also report for body composition analysis performed by the RD via InBody at Baseline, Day 90, and Day 180. InBody is a validated tool that utilizes direct segmental multi-frequency bioelectrical impedance analysis (DSM-BIA) to provide a highly accurate report of an individual's body composition. AIMS: Determine change in Percent Body Fat (PBF) and BMI during adjuvant hormone treatment for breast cancer patients. STATS/TARGET ACCRUAL: To assess % change in BMI and PBF between baseline and 180 days, one-sample t-tests will be used. Assuming an average (avg) baseline BMI of 33.7 with a standard deviation of 8.5; a sample of 120 patients will yield 89.4% power using a two-sided t-test to detect a 13% reduction in BMI to an avg of 29.32 and 82.8% power to detect a 12% reduction to an avg BMI of 29.656. Similarly, a t-test will have 83.7% power to detect a 12% decrease in % change in PBF assuming an avg baseline PBF of 41.36 with a standard deviation 10.5. The power calculations were accomplished by generating simulations of size 10,000 replications conducted at the 0.025 significance level using the TTEST procedure of SAS 9.4 [SAS Institute Inc., Cary, NC, USA]. The calculations assume a linear correlation of 0.5 between the baseline and Day 180 measurements and are Bonferroni corrected to maintain a familywise error of 0.05 for the primary analysis. All statistical analyses will be conducted using SAS 9.4. Statistical significance will be defined as p < 0.05. Citation Format: Scheuer R, Bendinger GM, Ensor Jr. JE, Nixon D, Randolph K, McGuirec E, Rados K, McNight JE, Pabbathi H, Panicker R, Johnson AT, Langlois C, Lammersfeld C, Alvarez RH. Positive behavior change and weight loss in breast cancer survivors on hormonal adjuvant therapy: An energy balance research in cancer (EnBaR) prospective study [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-07-03.
BACKGROUND: Problems related to sexual function are known to affect quality of life in female breast cancer survivors (BCS). A leading symptom of sexual dysfunction reported by BCS is dyspareunia, defined as moderate to severe penetrative pain with intercourse that results in reduced frequency of intercourse or abstinence. Dyspareunia in females is most commonly caused by vaginal dryness and primarily treated with estrogen therapy, a contraindication for many BCS. A recent trial found that estrogen-deficient BCS with dyspareunia who applied topical lidocaine to the vulvar vestibule (VV) prior to penetrative intercourse (PI) reported decreased pain during PI and improvement of sexual distress (Goetsch MF, JCO 2015). Identification of additional non-hormonal therapies to target the VV prior to PI may therefore provide treatment options for the improvement of sexual dysfunction in BCS with dyspareunia. TRIAL DESIGN: This is a double-blind, randomized trial to evaluate the benefits of applying natural lubricant MoistHer (MH) to the VV prior to PI in female BCS with dyspareunia. Subjects must be female ≥18 years BCS without active treatment (except for hormonotherapy), in a stable heterosexual partnership for ≥5 years, and report ≥ 3 months of consistent pain with PI. Patients with a history of pelvic pain, pelvic floor myalgia, vulvar dermatoses, or vaginismus will be excluded. Subjects will be randomized 1:1 to blinded home therapies of either MH or Topical Lidocaine (TL) for application to VV. MH is a commercially available vaginal moisturizer made of emu oil, tocopherol, safflower oil, and aloe extract and will be supplied by manufacturer Dromeo Inc. TL will be a 4% aqueous lidocaine hydrochloride solution prepared by research pharmacist (RP). Both MH and TL will be dispensed by RP in identical unmarked bottles. Subjects will agree to apply study liquid to VV and attempt PI at least twice per week for 4 weeks while maintaining a study diary to record pain scores. Outcomes will be measured via Sexual Function Questionnaire (SFQ), Female Sexual Distress Score-Revised (FSDS-R), and a rating of pain during PI on a scale of zero (no pain) to 10 (worst pain) via Numerical Rating Scale (NRS), to be completed by subjects at baseline, 2 weeks, and 4 weeks. AIMS: Primary endpoint is pain with PI, to be reported as a score on the NRS. Secondary endpoints are improved quality of sexual life and resumption of PI, to be measured by the SFQ and FSDS-R. STATS/TARGET ACCRUAL: A total of 50 patients will be recruited and randomized to receive either MH or TL at a 1:1 ratio (25 per group) using the Pocock-Simon dynamic allocation method. This sample size will achieve 94% power to detect at least 1.5 points NRS mean difference between treatments. NRS change will be compared between the two arms using a two-sample t-test (Pooled Standard error or Satterthwaite approximation as appropriate). Secondary outcomes include the SFQ and FSDS-R for which a longitudinal analysis of subscale scores will be conducted using a generalized linear mixed-effects model with fixed effects for treatment group and time. All statistical analyses will be conducted using SAS 9.3 [SAS Institute Inc., Cary, NC, USA]. Statistical significance will be defined as p < 0.05. Citation Format: Bendinger GM, Baptist S, Alvarez Tapias C, McGuire E, Rados K, Nixon D, Randolph K, McNight JE, Pabbathi H, Panicker R, Johnson AT, Geisler JP, Manahan KJ, Lammersfeld C, Avarez RH. A randomized study comparing MoistHer to topical lidocaine for female breast cancer survivors with dyspareunia [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-07-04.
BACKGROUND: The increase in breast cancer (BC) survival is largely due to the benefits of hormonal therapy, such as tamoxifen and aromatase inhibitors (AIs), for the treatment of hormone-sensitive breast cancer. Recent clinical trials have demonstrated that AIs are more effective than tamoxifen at reducing BC recurrences. However, BC patients receiving AIs have a higher incidence of osteoporosis, bone fractures, and musculoskeletal symptoms, particularly joint pain and stiffness. The incidence of AIIA in the ATAC trial was 27.8% in patients taking anastrozole versus (vs) 21% in patients taking tamoxifen (Baum M, Lancet 2002). The arthralgia associated with AIs can be so debilitating that it contributes to a significant percentage of non-compliance and discontinuation of systemic treatment. Patients with cancer often show interest in complementary and integrative modalities for symptom management (Vickers AJ, Lancet 2001), of which Acupuncture (Ac) is one of the most utilized therapies. ELIGIBILITY: Subjects must be female ≥18 years, have undergone mastectomy or breast-sparing surgery, and must have recovered from all pain-related effects of the surgery and radiotherapy with a minimum washout period of 30 days prior to registration. Patients should have ER and PR positive BC and be actively taking a 3rd-generation AI (Anastrozole, Letrozole, or Exemestane) for at least the 30 days prior to registration and plan to continue for at least one year after registration. ECOG PS <2 and platelets counts > 50,000/uL. Patients must not have received topical analgesic with exception of oral NSAIDS drugs ≤14 days to registration. TRIAL DESIGN: This is a 12-week, two arm randomized (1:1) trial evaluating the benefit of Ac in BC patients experiencing AIIA. AIMS: The aim of this study is to investigate the effectiveness of an integrative approach using Ac vs usual care (UC) treatment consisting of NSAIDs for the management of the AIIA.Primary endpoint is to compare the difference of Brief Pain Inventory-Short Form (BPI-SF) score at baseline vs week 8 between Ac and UC groups. Secondary endpoints are a) to compare the difference of BPI-SF score at baseline vs week 12 between Ac and UC groups, b) to compare the difference in AI adherence between Ac and UC groups and c) to compare the difference in patient initiated AI discontinuation between Ac and UC groups. STATS/TARGET ACCRUAL: This is a randomized controlled phase II study with the goal to compare reduction in BPI-SF score for patients treated with Ac vs UC alone. Patients are randomized 1:1 between the two arms. Prior work has indicated a 2-point BPI-SF score reduction as clinically meaningful. A sample size of 56 patients yields a study with 90% power and a one-sided significance level of 0.025 to determine a difference in pain reduction ≥2. These calculations are based on the assumptions of normal distribution of the improvement in BPI-SF score and a standard deviation that is conservatively calculated to be 2.3. An additional 6 patients will be accrued to account for attrition. Citation Format: Frank HS, Bendinger GM, Ensor Jr. JE, Neufeld N, Nixon D, Randolph K, McGuire E, Rados K, McNight JE, Pabbathi H, Panicker R, Johnson AT, Lammersfeld C, Alvarez R. A randomized controlled trial comparing acupuncture versus usual care for the treatment of aromatase inhibitor-induced arthralgia (AIIA) in women with early-stage breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-02-04.
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