Elissa T. Bantug

Breast Cancer Follow-Up and Management After Primary Treatment: American Society of Clinical Oncology Clinical Practice Guideline Update

PURPOSE To provide recommendations on the follow-up and management of patients with breast cancer who have completed primary therapy with curative intent. METHODS To update the 2006 guideline of the American Society of Clinical Oncology (ASCO), a systematic review of the literature published from March 2006 through March 2012 was completed using MEDLINE and the Cochrane Collaboration Library. An Update Committee reviewed the evidence to determine whether the recommendations were in need of updating. RESULTS There were 14 new publications that met inclusion criteria: nine systematic reviews (three included meta-analyses) and five randomized controlled trials. After its review and analysis of the evidence, the Update Committee concluded that no revisions to the existing ASCO recommendations were warranted. RECOMMENDATIONS Regular history, physical examination, and mammography are recommended for breast cancer follow-up. Physical examinations should be performed every 3 to 6 months for the first 3 years, every 6 to 12 months for years 4 and 5, and annually thereafter. For women who have undergone breast-conserving surgery, a post-treatment mammogram should be obtained 1 year after the initial mammogram and at least 6 months after completion of radiation therapy. Thereafter, unless otherwise indicated, a yearly mammographic evaluation should be performed. The use of complete blood counts, chemistry panels, bone scans, chest radiographs, liver ultrasounds, pelvic ultrasounds, computed tomography scans, [(18)F]fluorodeoxyglucose-positron emission tomography scans, magnetic resonance imaging, and/or tumor markers (carcinoembryonic antigen, CA 15-3, and CA 27.29) is not recommended for routine follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination.

Use of Pharmacologic Interventions for Breast Cancer Risk Reduction: American Society of Clinical Oncology Clinical Practice Guideline

PURPOSE To update the 2009 American Society of Clinical Oncology guideline on pharmacologic interventions for breast cancer (BC) risk reduction. METHODS A systematic review of randomized controlled trials and meta-analyses published from June 2007 through June 2012 was completed using MEDLINE and Cochrane Collaboration Library. Primary outcome of interest was BC incidence (invasive and noninvasive). Secondary outcomes included BC mortality, adverse events, and net health benefits. Guideline recommendations were revised based on an Update Committees review of the literature. RESULTS Nineteen articles met the selection criteria. Six chemoprevention agents were identified: tamoxifen, raloxifene, arzoxifene, lasofoxifene, exemestane, and anastrozole. RECOMMENDATIONS In women at increased risk of BC age ≥ 35 years, tamoxifen (20 mg per day for 5 years) should be discussed as an option to reduce the risk of estrogen receptor (ER) -positive BC. In postmenopausal women, raloxifene (60 mg per day for 5 years) and exemestane (25 mg per day for 5 years) should also be discussed as options for BC risk reduction. Those at increased BC risk are defined as individuals with a 5-year projected absolute risk of BC ≥ 1.66% (based on the National Cancer Institute BC Risk Assessment Tool or an equivalent measure) or women diagnosed with lobular carcinoma in situ. Use of other selective ER modulators or other aromatase inhibitors to lower BC risk is not recommended outside of a clinical trial. Health care providers are encouraged to discuss the option of chemoprevention among women at increased BC risk. The discussion should include the specific risks and benefits associated with each chemopreventive agent.

The role of informatics in promoting patient-centered care

Patient-centered care is an important aspect of high-quality care. Health informatics, particularly advances in technology, has the potential to facilitate, or detract from, patient-centered cancer care. Informatics can provide a mechanism for patients to provide their clinician(s) with critical information and to share information with family, friends, and other patients. This information may enable patients to exert greater control over their own care. Clinicians may use information systems (e.g., electronic medical records) to coordinate care and share information with other clinicians. Patients and clinicians may use communication tools and information resources to interact with one another in new ways. Caution in using new information resources is warranted to avoid reliance on biased or inappropriate data, and clinicians may need to direct patients to appropriate information resources. Perhaps the greatest challenge for both patients and providers is identifying information that is high quality and that enhances (and does not impede) their interactions.

What do these scores mean? Presenting patient-reported outcomes data to patients and clinicians to improve interpretability

Patient‐reported outcomes (PROs) (eg, symptoms, functioning) can inform patient management. However, patients and clinicians often have difficulty interpreting score meaning. The authors tested approaches for presenting PRO data to improve interpretability.

Engaging stakeholders to improve presentation of patient-reported outcomes data in clinical practice

PurposePatient-reported outcomes (PROs) can promote patient-centered care, but previous research has documented interpretation challenges among clinicians and patients. We engaged stakeholders to improve formats for presenting individual-level PRO data (for patient monitoring) and group-level PRO data (for reporting comparative clinical studies).MethodsIn an iterative process, investigators partnered with stakeholder workgroups of clinicians and patients to address previously identified interpretation challenges. Candidate approaches were then tested in semi-structured, one-on-one interviews with cancer patients and clinicians. Interpretation issues addressed included conveying score meaning (i.e., what is good/bad) and directional inconsistency (whether higher scores are better/worse). An additional issue for individual-level PROs was highlighting potentially concerning scores and, for group-level PROs, identifying important between-group differences (clinical, statistical).ResultsOne-on-one interviews in a purposive sample of clinicians (n = 40) and patients (n = 39) provided insights regarding approaches to address issues identified. For example, adding descriptive labels to the Y-axis (none, mild, moderate, severe) helps address directional inconsistency and aids interpretation of score meaning. Red circles around concerning data points or a threshold line indicating worse-than-normal scores indicate possibly concerning scores for individual-level PRO data. For group-level PRO data, patients and some clinicians are confused by confidence limits and clinical versus statistical significance, but almost all clinicians want p values displayed.ConclusionsVariations in interpretation accuracy demonstrate the importance of presenting PRO data in ways that promote understanding and use. In an iterative stakeholder-driven process, we developed improved PRO data presentation formats, which will be evaluated in further research across a large population of patients and clinicians.

Coordination of care in breast cancer survivors: an overview.

The number of breast cancer survivors in the United States is increasing. With longer survival, there has been an increase in the complexity and duration of posttreatment care. Multidisciplinary care teams are needed to participate across the broad spectrum of issues that breast cancer survivors face. In this setting, the need for well-established patterns of communication between care providers is increasingly apparent. We have created a multidisciplinary approach to the management of breast cancer survivors to improve communication and education between providers and patients. This approach could be extended to the care and management of survivors of other types of cancer.

Adapting a couple-based intimacy enhancement intervention to breast cancer: A developmental study.

OBJECTIVE Sexual concerns continue to be poorly addressed for women treated for breast cancer and evidence-based interventions that adequately address these concerns are scarce. The objective of this study was to adapt a telephone-based intimacy enhancement intervention, previously tested in couples facing colorectal cancer, to the needs of women with breast cancer through qualitative focus groups, cognitive interviews, and expert review. METHOD Three semistructured qualitative focus groups in partnered posttreatment breast cancer survivors (n = 15) reporting sexual concerns were conducted to investigate experiences of breast cancer-related sexual concerns and intervention preferences. Focus group data were coded using the framework approach to qualitative analysis; 8 key themes were identified and used to develop the content and format of the intervention. Feedback from cognitive interviews with study-naïve breast cancer survivors (n = 4) and expert review of materials were also incorporated in finalizing the intervention materials. RESULTS Qualitative findings centered on the impact of breast cancer and its treatment on womens sexuality and on the intimate relationship, experiences of helpful and unhelpful coping methods, and explicit intervention preferences. Focus group data were particularly helpful in identifying the scope of educational topics and in determining how to structure intervention skills practice (e.g., intimacy-related communication) to be optimally relevant and helpful for both women and their partners. Cognitive interview feedback helped refine intervention materials. CONCLUSION An intimacy enhancement intervention was adapted for women with breast cancer and their partners. This intervention offers a promising, potentially disseminable approach to addressing breast cancer-related sexual concerns. (PsycINFO Database Record

Presenting comparative study PRO results to clinicians and researchers: beyond the eye of the beholder

PurposePatient-reported outcome (PRO) results from clinical trials can inform clinical care, but PRO interpretation is challenging. We evaluated the interpretation accuracy and perceived clarity of various strategies for displaying clinical trial PRO findings.MethodsWe conducted an e-survey of oncology clinicians and PRO researchers (supplemented by one-on-one clinician interviews) that randomized respondents to view one of the three line-graph formats (average scores over time for two treatments on four domains): (1) higher scores consistently indicating “better” patient status; (2) higher scores indicating “more” of what was being measured (better for function, worse for symptoms); or (3) normed scores. Two formats displayed proportions changed (pie/bar charts). Multivariate modeling was used to analyze interpretation accuracy and clarity ratings.ResultsTwo hundred and thirty-three clinicians and 248 researchers responded; ten clinicians were interviewed. Line graphs with “better” directionality were more likely to be interpreted accurately than “normed” line graphs (OR 1.55; 95% CI 1.01–2.38; p = 0.04). No significant differences were found between “better” and “more” formats. “Better” formatted graphs were also more likely to be rated “very clear” versus “normed” formatted graphs (OR 1.91; 95% CI 1.44–2.54; p < 0.001). For proportions changed, respondents were less likely to make an interpretation error with pie versus bar charts (OR 0.35; 95% CI 0.2–0.6; p < 0.001); clarity ratings did not differ between formats. Qualitative findings informed the interpretation of the survey findings.ConclusionsGraphic formats for presenting PRO data differ in how accurately they are interpreted and how clear they are perceived to be. These findings will inform the development of best practices for optimally reporting PRO findings.

A qualitative exploration of the experiences, needs, and roles of caregivers during and after cancer treatment: “That’s what I say. I’m a relative survivor”

PurposeThe transition out of acute cancer treatment has been identified as a time of stress and uncertainty for cancer survivors, but little is known about how caregivers fare during this period. In this paper, we discuss caregiving work up to and including transition from initial care and the needs of caregivers during transition and beyond.MethodsWe held four focus groups with breast, prostate, and colorectal cancer survivors who had completed treatment with intent to cure and two with caregivers for the same population. Participants were affiliated with either an urban academic or rural community cancer center. The discussions focused on cancer-related experiences and needs during the transition out of acute cancer care.ResultsFocus groups included 47 people: 28 survivors and 19 caregivers. Three key caregiving themes identified the significance of support for the patient in the clinic, support for the patient in the home, and for caregiver self-care.ConclusionsDiscussions revealed aspects of caregiving that created difficulties for the caregiver themselves or between the caregiver and the cancer survivor. Caregiver experiences and needs may warrant explicit attention as survivors and caregivers are adjusting to a “new normal” that is no longer centered on getting through treatment.Implications for cancer survivorsPatients and informal caregivers are often conceptualized as a “unit of care”; consideration of the needs of both is important for the provision of appropriate and effective health services.

Making it work: Breast cancer survivorship care at Johns Hopkins.

61 Background: Breast cancer survivor numbers are increasing due to population aging and improved treatment outcomes but many of their long-term health care needs are unmet. Integrated follow-up care strategies that enhance care coordination, education, and access to survivorship resources are needed to provide patients with evidence-based care that addresses medical and psychosocial needs after cancer treatment. METHODS In 2008, we established the Johns Hopkins Breast Cancer Survivorship Program with representation from the Schools of Nursing, Public Health, and Medicine to address the needs of patients completing initial cancer treatment and transitioning to long-term follow-up. Patient educational resources were created within an interactive website ( http://bit.ly/hZfzFi ) including > 35 patient/provider educational video clips, blogs and social media. Activities including provider educational events, educational folders, and trainee curriculum additions have been ongoing. Starting May 2011, Hopkins patients were offered a one-time transition visit with a nurse practitioner focusing on individualized treatment summary/survivorship care plan activities (e.g., cancer screening/surveillance, medical intervention, psychosocial support, and care coordination with non-cancer providers). RESULTS Our website is averaging 3,000 hits monthly. We have participated in 22 provider/trainee formal educational presentations. In the pilot phase of these transition visits (n=40), age/race breakdown of participants were representative of our breast cancer population (median age 51, range 34-69; 17% African Americans). Our post-visit survey (n=37), 97% found the survivorship visit beneficial and all reported that this one-time consultation helped with transitioning away from treatment. CONCLUSIONS A multidisciplinary patient-centered approach to breast cancer survivorship allowed us to develop comprehensive clinical and educational service models to benefit patients and their cancer/non-cancer providers. This program aims to enhance education, overcome the fragmentation of the health care system, and improve overall health and wellness of breast cancer survivors as they transition to long-term survivorship.