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.
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