Patricia Mumby

Prospective Multicenter Study of the Impact of the 21-Gene Recurrence Score Assay on Medical Oncologist and Patient Adjuvant Breast Cancer Treatment Selection

PURPOSE The 21-gene Recurrence Score (RS) assay has been validated to quantify the risk of distant recurrence in tamoxifen-treated patients with lymph node-negative, estrogen receptor-positive breast cancer and predict magnitude of chemotherapy benefit. This multicenter study was designed to prospectively examine whether RS affects physician and patient adjuvant treatment selection and satisfaction. PATIENTS AND METHODS Before and after obtaining the 21-gene RS assay, medical oncologists stated their adjuvant treatment recommendation and confidence in it. Patients also indicated their treatment choice pre- and post-RS assay. Patients completed measures for decisional conflict, anxiety, and quality of life. RESULTS Seventeen medical oncologists at one community and three academic practices consecutively enrolled 89 assessable patients. The medical oncologist treatment recommendation changed for 28 patients (31.%). Twenty-four patients (27%) changed their treatment decision. The largest change after the RS results was conversion from the medical oncologists pretest recommendation for chemotherapy plus hormonal therapy (CHT) to post-test recommendation for hormone therapy (HT) in 20 cases (22.5%). Nine patients (10.1%) changed their treatment decision from CHT to HT. RS results increased medical oncologist confidence in their treatment recommendation in 68 cases (76%). Patient anxiety and decisional conflict were significantly lower after RS results. CONCLUSION The results of this study indicate that the RS assay impacts medical oncologist adjuvant treatment recommendations, patient treatment choice, and patient anxiety.

Improving Subject Recruitment, Retention, and Participation in Research through Peplau’s Theory of Interpersonal Relations:

Recruitment and retention of persons participating in research is one of the most significant challenges faced by investigators. Although incentives are often used to improve recruitment and retention, evidence suggests that the relationship of the patient to study personnel may be the single, most important factor in subject accrual and continued participation. Peplau’s theory of interpersonal relations provides a framework to study the nurse-patient relationship during the research process. In this paper the authors provide a brief summary of research strategies that have been used for the recruitment and retention of subjects and an overview of Peplau’s theory of interpersonal relations including its use in research studies. In addition, a discussion of how this theory was used for the successful recruitment and retention of women with type 2 diabetes who participated in a clinical trial using a nurse-delivered psychoeducational intervention for depression is addressed.

Autologous hematopoietic stem cell transplants that utilize total body irradiation can safely be carried out entirely on an outpatient basis

Outpatient hematopoietic stem cell transplants (HSCT) are usually performed in patients receiving minimally mucotoxic preparative regimens; total body irradiation (TBI)-based regimens typically are excluded. To improve resource utilization and patient satisfaction, we developed a totally outpatient HSCT program for TBI regimens and compared outcomes for our first 100 such transplants to 32 performed as in-patients during the same interval, for caregiver or financial reasons. Symptoms were managed predominately with oral agents; pain management consisted of transdermal fentanyl and oral morphine solution. Except for more unmarried in-patients, the two groups were matched. Time to engraftment, severity of mucositis and transplant duration were identical for the two groups. Twenty-seven of the outpatients were admitted (median-6 days), primarily for progressing infection. Thus 92% of all transplant days were outpatient. There were no septic episodes or hospital admissions for pain management. There were no deaths to day 30 in either group and 100-day survival was identical. There was a mean cost savings of

Predictors of non-compliance in autologous hematopoietic SCT patients undergoing out-patient transplants

16 000 per outpatient transplant and outpatient patient/caregiver quality of life was similar to that reported for in-patients. Patients undergoing severely mucotoxic regimens can be safely transplanted in an outpatient setting with a significant cost saving, with no increase in morbidity or mortality.

Comparison of early quality of life outcomes in autologous and allogeneic transplant patients.

Non-compliance has received significant attention in medicine, yet few studies have examined its correlates in autologous hematopoietic SCT (AHSCT) patients. This study examined predictors of non-compliance in a sample of 151 AHSCT patients treated in an outpatient setting. Before AHSCT, participants completed a validated measure of mood and retrospective chart reviews were conducted to assess non-compliance during AHSCT, defined as refusal of oral hygiene, prescribed exercise programs, oral nutrition and/or prescribed medications. We found 121 patients (80%) were non-compliant with an aspect of the AHSCT regimen on 1 or more days; mean percentage of non-compliant days was 16.6 (s.d. 15.6). Men were more likely than women to be non-compliant (P<0.05); as were participants with an elevated depression score (P<0.05). Stepwise regression models identified significant predictors of non-compliance: gender, depression, global distress and nausea and vomiting severity (P-values all <0.01). Further analysis revealed that the interaction of the psychological variables with gender was a more robust predictor of non-compliance (P<0.001). For outpatient AHSCT, our findings suggest the need to broaden conceptualizations of risk factors for non-compliance and the importance of assessing patient barriers to compliance to ensure optimal treatment outcome.

Assessing Breast Cancer Risk and Providing Treatment Recommendations: Immediate Impact of an Educational Session

The Functional Assessment of Cancer Therapy-Bone Marrow Transplant measures quality of life (QOL) in SCT patients. Prior reports found mixed results regarding QOL differences among autologous and allogeneic SCT patients. In addition, there is a paucity of literature examining differences in QOL patterns over time between autologous and allogeneic patients. The present study examines differences in QOL between patients free of clinical depression undergoing autologous (n=41) and allogeneic (n=64) SCT during early stages of treatment. Despite clinical differences, autologous and allogeneic patients demonstrated similar changes in QOL. The exception was the Functional subscale which indicated worse QOL for allogeneic patients at discharge (F test=4.61, df=1, P<0.05); allogeneic patients (Mean=13.06, s.d.=5.36) indicated they were less able to function at work and were less accepting of their illness than autologous patients (Mean=16.02, s.d.=6.73). There was a significant main effect for time on nearly all QOL subscales (P<0.05) demonstrating decline during treatment and return to baseline by discharge; only the Social Well-Being scale did not significantly change over time. These results help to understand patients’ response to SCT in the earliest stages and ultimately help identify patients at risk who could benefit from therapeutic interventions.

Extended follow-up results from a prospective multi-center study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection, satisfaction, and anxiety.

Abstract:  The widespread availability of information regarding advancements in breast cancer care has heightened public awareness about risk and prevention, but there is limited knowledge as to the translation of these evolving advancements into physician practice patterns. The purpose of this study was to: (a) determine current practice patterns/treatment recommendations for evaluating patients at high‐risk for breast cancer and (b) measure the immediate effect of an educational session on new knowledge acquired for high‐risk patients. Five thousand and one health care provider surveys were sent to physicians in the greater Chicago area. The survey inquired about practice patterns and offered an opportunity to attend an educational session utilizing our “Spectrum of Care Options” framework. To evaluate session effectiveness, pre and post‐tests were administered to participants. Of 767 survey respondents, 78 attended an educational session, 64 completed a pre and post‐test, and 65 completed program evaluations. Pretest scores averaged 67.1% correct (range = 29–100%, SD = 15.8%) while post‐test scores averaged 80.3% correct (range = 59–100%, SD = 11.0%), p < 0.0001. Participants rated the following on a 1–5 (poor to excellent) Likert scale (average scores): presentations 4.74, instructional materials 4.58, usefulness to practice 4.60, new knowledge gained 4.71, and likelihood of changing practice 4.49. Primary care physicians and surgeons are interested in identifying and treating high‐risk patients, but may lack sufficient state‐of‐the art knowledge to do so. An educational session providing information on this subject, based on Spectrum of Care Options, significantly improved their knowledge and may influence their future practices.

Cancer Survivorship Care: How Primary Care Providers Perceive Their Role.

CTRC-AACR San Antonio Breast Cancer Symposium: 2008 Abstracts Abstract #3113 Background: The 21-gene Recurrence Score (RS) assay has been validated to quantify the risk of distant recurrence in tamoxifen treated patients (pts) in node negative, estrogen receptor positive breast cancer (BC) and predict magnitude of chemotherapy benefit. We previously showed that the RS impacted medical oncologists (MOs) and pts adjuvant treatment decision making, decreased situational anxiety and decisional conflict, and improved pt satisfaction regarding adjuvant treatment decisions. Herein, we present the 12 month post-RS data for MOs and pts. Material and Methods: MOs stated their treatment recommendation and confidence in it pre- and post-RS assay, and completed a 12 month questionnaire. Pts completed 4 questionnaires pre- and immediately post-RS, and 12 months later: 1) Patient Treatment Decision Making Questionnaire; 2) Decisional Conflict Scale (DCS); 3) State-Trait Anxiety Inventory; and 4) Functional Assessment of Cancer Therapy-Breast. Frequency distributions, means and standard deviations summarized data. Paired samples t-tests and repeated measures ANOVA assessed quality of life, decisional conflict and anxiety. Results: Accrual goal was met with 89 evaluable pts. 16/17 (94%) MOs and 67 pts (75%) completed the 12 month assessment. There were no breast cancer recurrences recorded at 12 months. The majority of MOs reported increase confidence in their treatment recommendation (n=15, 93.8%), felt the RS provided additional information (n=15, 93.8%), and influenced treatment recommendation (n=14, 87.6%). Results from the DCS immediately post-RS indicate reduced conflict over treatment ( p <.0001), greater pt satisfaction, and increased confidence with choice of adjuvant therapy ( p <.0001). Pts reported they were glad they took the test 12 months later (n=62, 92.5%), found results easy to understand (n=60, 89.6%), and the test influenced treatment decision (n=54, 80.6%). Sixty four (95.5%) were satisfied with their adjuvant decision. State anxiety decreased over the year (mean 38.9 to 34.0, p . = 007), the most significant decline occurred pre- to immediately post-RS. Quality of life remained constant. Conclusions: The RS assay has an immediate and enduring impact on MOs and pts adjuvant decision making. MOs and pts report continued confidence and satisfaction with the assay. Pts had a decrease in decisional conflict right after the test, situational anxiety declined over the next 12 months and quality of life remained stable. Investigator initiated trial supported by an unrestricted clinical trials grant from Genomic Health Inc. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 3113.

Vitamin D Supplementation Improves Mood in Women with Type 2 Diabetes

Background: The majority of cancer survivors are breast cancer patients since about 80% live five years beyond diagnosis. It is projected that by 2020, demand for medical oncologists will exceed supply, in large part due to this increased number of cancer survivors. One proposed solution to address the disparity of resources is to enlist primary care physicians (PCP) in the care of cancer survivors. This pilot study aims to describe the perceptions of primary care physicians relative to cancer survivorship care.Materials and Methods: We conducted a prospective, cross sectional survey of PCPs including internists, family practitioners and gynecologists in the outpatient setting. The primary outcome measure was a 45 item measure of knowledge and perceived role of the PCP in the care of cancer survivors.Results: A total of 84 PCPs of 200 surveyed (42%) responded. Overall, 66 PCPs stated they are interested in participating in the care of cancer survivors (79%); however, only a minority of the PCPs commonly discuss the survivorship phase of the cancer control continuum (n=8, 10%). The majority of PCPs believe that the medical oncologist should remain active in the follow up care in association with the PCP (n=28, 36%) or as a single provider (n=17, 20%). Only 20 PCPs (25%) agreed or strongly agreed that survival outcomes are similar for PCPs and medical oncologists. Most PCPs felt that cancer survivors are more compliant with survivorship care recommendations when proposed by the medical oncologist versus PCP (n=42, 55%). The majority of PCPs felt that survivorship follow up care guidelines would be extremely helpful or very helpful (n=61, 81%), a treatment summary of care document would be extremely helpful or very helpful (n=60, 80%), and a treatment summary care plan would change current practice (n=67, 90%). PCPs treat co-morbidities such as diabetes mellitus, obesity and hypertension; however only a minority of PCPs are aware of the relationship between co-morbidities and cancer survivorship. A little over a third of the PCPs strongly agreed that co-morbidities impacted upon the incidence of cancer, incidence of cancer recurrence and overall cancer mortality; n=30, (39%), n=27 (35%), and n=41 (42%) respectively.Discussion: Although PCPs recognize the opportunity to favorably impact on cancer survivorship issues, there appears to be a level of uncertainty regarding their role. PCPs are receptive to participating in the care of cancer survivors provided that they are given the necessary educational resources to do so. Interventions need to be developed and validated to improve the role of the PCP cancer survivorship care. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 1061.

Multiple Breast Cancer Risk Factors Do Not Improve Patient Acceptance of Chemoprevention.

Objective The aim of this study was to determine the effect of vitamin D supplementation on improving mood (depression and anxiety) and health status (mental and physical) in women with type 2 diabetes mellitus (T2DM). Methods Fifty women with T2DM and significant depressive symptomology were enrolled into the “Sunshine Study,” where weekly vitamin D supplementation (ergocalciferol, 50,000 IU) was given to all participants for six months. The main outcomes included (1) depression (Center for Epidemiologic Studies Depression, CES-D, and Patient Health Questionnaire, PHQ-9), (2) anxiety (State-Trait Anxiety), and (3) health status (Short Form, SF-12). Results Forty-six women (92%) completed all visits. There was a significant decrease in depression (CES-D and PHQ-9, p < 0.001) and anxiety (state and trait, p < 0.001). An improvement in mental health status (SF-12, p < 0.001) was also found. After controlling for covariates (race, season of enrollment, baseline vitamin D, baseline depression (PHQ-9), and body mass index), the decline in depression remained significant (CES-D, p < 0.001). There was a trend for a better response to supplementation for women who were not taking medications for mood (antidepressants or anxiolytics) (p = 0.07). Conclusions Randomized trials to confirm that vitamin D supplementation can improve mood and health status in T2DM women are needed.