Donna A. Pucci

Feasibility trial of electroacupuncture for aromatase inhibitor--related arthralgia in breast cancer survivors.

Background. Arthralgia affects postmenopausal women receiving aromatase inhibitors (AIs) for breast cancer. Given the existing evidence for electroacupuncture (EA) for treatment of osteoarthritis in the general population, this study aims to establish the feasibility of studying EA for treating AI-related arthralgia. Patients and Methods. Postmenopausal women with stage I-III breast cancer who reported AI-related arthral gia were enrolled in a single-arm feasibility trial. EA was provided twice a week for 2 weeks followed by 6 weekly treatments. The protocol was based on Chinese medicine diagnosis of “Bi” syndrome with electrostimulation of needles around the painful joint(s). Pain severity of the modified Brief Pain Inventory was used as the primary outcome. Joint stiffness, joint interference, and Patient Global Impression of Change (PGIC) were secondary outcomes. Paired t tests were used for analysis. Results. Twelve women were enrolled and all provided data for analysis. From baseline to the end of intervention, patients reported reduction in pain severity (from 5.3 to 1.9), stiffness (from 6.9 to 2.4), and joint symptom interference (from 4.7 to 0.8), all P < .001; 11/12 considered joint symptoms “very much better” based on the PGIC. Subjects also reported significant decrease in fatigue (from 4.4 to 1.9, P = .005) and anxiety (from 7.1 to 4.8, P = .01). No infection or development or worsening of lymphedema was observed. Conclusion. Preliminary data establish the feasibility of recruitment and acceptance as well as promising preliminary safety and effectiveness. A randomized controlled trial is warranted to establish the efficacy of EA for AI-related arthralgia in breast cancer survivors.

Adult survivors of childhood cancer: the medical and psychosocial late effects of cancer treatment and the impact on sexual and reproductive health.

INTRODUCTION There are over 13 million cancer survivors in the United States, which constitutes 3-4% of the U.S. population. According to the Surveillance Epidemiology and End Results program (SEER) data the 5-year overall survival rate for children diagnosed with cancer between ages 0-19 is 83.1%, and 2/3 of childhood cancer survivors will experience at least one late effect of treatment. AIM To provide a brief overview of the medical and psychosocial effects of cancer treatments in survivors of childhood cancer with a focus on sexual and reproductive health issues in this population. METHODS The development of a manuscript from a presentation at the Annual Society of Sexual Medicine meeting. An overview of long-term and late effects of treatment experienced by young adult cancer survivors was presented. MAIN OUTCOME MEASURE This manuscript is based on a presentation that reviewed the medical and psychosocial literature, consensus statements of professional groups, and clinical observations. RESULTS Cancer and cancer treatments have both direct and indirect effects of physiological, psychological, and interpersonal factors that can negatively impact the health and well-being of cancer survivors including sexual and reproductive function and satisfaction. CONCLUSIONS Cancer, its management, and the resulting late effects must be explored and understood by providers caring for childhood cancer survivors so that educational, psychological, pharmacologic, as well as preventive interventions can be implemented with this population.

Feasibility trial of electro-acupuncture for aromatase inhibitor related arthralgia in breast cancer survivors.

Background. Arthralgia affects postmenopausal women receiving aromatase inhibitors (AIs) for breast cancer. Given the existing evidence for electroacupuncture (EA) for treatment of osteoarthritis in the general population, this study aims to establish the feasibility of studying EA for treating AI-related arthralgia. Patients and Methods. Postmenopausal women with stage I-III breast cancer who reported AI-related arthral gia were enrolled in a single-arm feasibility trial. EA was provided twice a week for 2 weeks followed by 6 weekly treatments. The protocol was based on Chinese medicine diagnosis of “Bi” syndrome with electrostimulation of needles around the painful joint(s). Pain severity of the modified Brief Pain Inventory was used as the primary outcome. Joint stiffness, joint interference, and Patient Global Impression of Change (PGIC) were secondary outcomes. Paired t tests were used for analysis. Results. Twelve women were enrolled and all provided data for analysis. From baseline to the end of intervention, patients reported reduction in pain severity (from 5.3 to 1.9), stiffness (from 6.9 to 2.4), and joint symptom interference (from 4.7 to 0.8), all P < .001; 11/12 considered joint symptoms “very much better” based on the PGIC. Subjects also reported significant decrease in fatigue (from 4.4 to 1.9, P = .005) and anxiety (from 7.1 to 4.8, P = .01). No infection or development or worsening of lymphedema was observed. Conclusion. Preliminary data establish the feasibility of recruitment and acceptance as well as promising preliminary safety and effectiveness. A randomized controlled trial is warranted to establish the efficacy of EA for AI-related arthralgia in breast cancer survivors.

Abstract P5-13-12: Symptom burden, unmet need for assistance, and psychosocial adaptation among longer term breast cancer survivors

Introduction: Advances have improved survival among breast cancer (BC) patients and 89% can expect >5 year survival. The price for this survival, however, may be physical and psychosocial symptoms that persist many years into the survivorship trajectory. Unmet needs for symptom management and the relationships between unmet needs, symptom burden, and psychosocial adaptation remain unclear. We examined these relationships among longer term BC survivors. Method: Eligibility included non-metastatic BC survivors diagnosed > 3 years prior and attendance at a survivorship-focused appointment. Nineteen common symptoms of disease and treatment were evaluated and participants reported unmet need for assistance for each symptom they experienced. Psychosocial adaptation was assessed through the Hospital Anxiety and Depression Scale (HADS). Results: 103 primarily white (72%), middle aged (M=62.7 yrs) BC survivors were recruited. Participants were, on average, 11.4 yrs from diagnosis and most (78.2%) reported Stage I or II BC. Participants reported an average of 9.2 symptoms, most commonly fatigue (67%), joint pain (66%), weight gain (60%), decreased sexual drive (55%), and insomnia (52%). Participants reported an average of 2.8 unmet needs for assistance with symptoms, most commonly joint pain (29%), fatigue (25%), weight gain (23%), and difficulty with memory (21%). Overall levels of depressive (M=2.45) and anxiety (M=4.89) symptoms were low, and elevated depressive and anxiety symptoms were reported by 3% and 18% of the sample, respectively. Number of symptoms and anxiety were unrelated to any demographic, disease or treatment variables. Depressive symptoms and unmet needs were related younger age (p 0.49, p 0.31, p Conclusion: Among long term BC survivors symptoms are common, while unmet need and symptoms of anxiety and depression are more modest. However, both symptoms and unmet need are associated with symptoms of depression and anxiety and represent a potentially missed opportunity for improving outcomes among BC survivors. Citation Format: Palmer SC, Blauch AN, Pucci DA, Jacobs LA. Symptom burden, unmet need for assistance, and psychosocial adaptation among longer term breast cancer survivors [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 P5-13-12.

Abstract P4-10-11: Comparability of computerized and paper-pencil patient reported outcome (PRO) assessments – Does it matter how they are administered?

Introduction: There is an increased need to monitor and intervene to assist breast cancer (BC) survivors overcome the long-term and late effects of treatment. Many institutions are moving toward computerized assessments (CA) of PROs such as symptoms and concerns in place of more traditional paper and pencil administration, but little work has been performed to demonstrate that these very different methods of administration produce comparable results. Our goal was to evaluate the outcomes produced by these methods by comparing two similar samples of breast cancer survivors, one of which completed a PROs assessment using paper and pencil (PP), the other of which was assessed using a computerized system that links to the patient portal in use at our facility. Data collection of the CA of PROs is ongoing. Method: Women were eligible if they had a confirmed diagnosis of Stage 0-III BC, were within one year of completion of primary therapy, and were scheduled for a survivorship-focused end of treatment visit. As this was a naturalistic cohort study, no randomization was undertaken. The PRO assessment covered 19 common long-term or late effects of treatment, inquiring about their occurrence and severity in the previous month. On the day of the visit, participants in the PP cohort were provided with the questionnaire packet to complete prior to meeting with their provider. The women who completed the CA were either already enrolled in the patient portal or enrolled at the time of recruitment and sent an online version of the same questionnaire. Reminder calls and/or emails were sent to the CA participants to improve compliance. Results: 164 BC survivors completed the PP questionnaire, and 62 women completed the CA. Racial make-up, marital status, and education, were similar between groups. Women in the PP group were older than those in the CA group (55.45 vs. 51.23 yrs, p With respect to PROs, there were no significant differences between groups in either the proportion of women endorsing a given symptom/concern or in the mean severity rating for any symptom/concern. The five most commonly reported concerns did differ somewhat between groups, with PP reporting Fatigue, Insomnia, Hot Flashes, Aching Joints, and Memory Difficulties, respectively, and CA reporting Fatigue, Anxiety, Body Image Problems, Memory Difficulties, and a tie between Insomnia and Depression, respectively. Conclusion: The results of the PRO assessment can be assumed to be comparable whether the method of administration is either PP or computerized. Differences found between groups in the most commonly endorsed symptoms likely reflected differences in age and menopausal status. Citation Format: Palmer SC, DeMichele A, Glanz K, Schapira M, Pucci DA, Blauch AN, Jacobs LA. Comparability of computerized and paper-pencil patient reported outcome (PRO) assessments – Does it matter how they are administered?. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-10-11.

Abstract OT3-03-02: Assessment of cancer Concerns at the End of treatment (ACE): What do survivors need and want?

Discussion: There are over 14 million cancer survivors in the United States today and this population will continue to grow. Not only are survivors at risk for recurrence, but increasingly complex treatments place them at risk for a range of long-term and late effects. Provision of survivorship care plans (SCPs) at an end of treatment (EOT) visit that includes referrals to appropriate resources may be assumed to improve the care provided to survivors. There are, however, few relevant studies examining the outcomes of providing patients with referrals to resources identified through the completion of patient reported outcomes (PROs) reported in the literature. Current research has focused on documenting the frequency with which SCPs are provided and the perceived usefulness of these documents. Such data are a necessary but an insufficient step in the creation of practice guidelines in part guided by PROs, or standards of care that support the provision of SCPs. This study will provide a comprehensive description of breast cancer (BC) survivors9 symptom burden and other concerns, as well as health behaviors as they enter the survivorship phase of care. These items will be evaluated by data generated by a pre visit PROs questionnaire completed through the patient portal. Significant symptoms and concerns will be addressed during a clinical encounter at the EOT visit. It will also describe referrals triggered by these data. Trial Design: Quasi-experimental single-group design with historical controls. Our study describes patient-reported symptom burden, desire for assistance, quality of life (QoL) and health behaviors of BC survivors who have completed initial treatment using a web-based platform to collect PRO data. As well, it estimates differences in referral and uptake between participants and historical controls. Eligibility Criteria: Survivors must understand English, have internet access and a working email address, and be age 18 years or older within 1 year of completing initial treatment (chemotherapy, radiotherapy, and/or surgery). Participants may still be receiving hormonal or targeted therapy. Specific Aims: 1) Describe physical and psychosocial PROs of BC survivors after completion of treatment so as to define targets and develop metrics for future intervention; 1A) examine diagnosis and treatment variables that moderate PROs; 2) determine provider satisfaction with a web based patient questionnaire that includes a summary of significant patient concerns; 3) estimate the impact of providing the summary of patient concerns on utilization of/referral to available services relative to historic controls. Statistical Methods: Parameter estimates with confidence intervals for concerns and desire for help. Bivariate associations between unmet needs and quality of life. Non-parametric comparison of referral patterns between ACE participants and historical controls. Present Accrual and Target: To date 107 BC survivors have consented to complete a self-report survey questionnaire prior to their scheduled EOT visit, 61 completed the survey, 28 pending a visit. Target 250. Citation Format: Jacobs LA, DeMichele A, Glanz K, Schapira M, Pucci DA, Blauch AN, Palmer SC. Assessment of cancer Concerns at the End of treatment (ACE): What do survivors need and want?. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT3-03-02.