Aim 3: Improve the Experience of Patients During Treatment and Post-Treatment Survivorship

Our research in Aim 3: Improve the experience of patients during treatment and post-treatment survivorship focuses on:

  • Symptom control, toxicities and quality of life
  • Molecular epidemiology and informatics approaches to improve prognosis and other health outcomes
  • Health care delivery and health disparities

Major ongoing research efforts related to Aim 3 include:

  • A proof-of-concept study to investigate whether patient-specific adult stem cell-derived neurons can predict the susceptibility to chemotherapy-induced peripheral neuropathy, which affects 30% to 40% of patients treated with neurotoxic chemotherapy and results in dose-limiting pain, numbness and weakness that can lead to long-term illness (R01 CA211887; Nathan P. Staff, M.D., Ph.D., principal investigator).

  • Monitoring physical activity during multiagent chemotherapy using wearable devices paired with patient reports and objective measures of fitness (FDA CERSI project, Gita Thanarajasingam, M.D., principal investigator).

  • A study to test whether a male hormone blocker (topical ketoconazole) will palliate a rash caused by epidermal growth factor receptor (EGFR) inhibitors in a diverse cohort of patients with cancer. The rash is common (50% to 90% of patients; severe in 10% to 20%), commonly affects the face, and can cause significant cutaneous pain, psychosocial distress and isolation, leading to discontinuation of a highly effective treatment (R01 CA207183; Aminah Jatoi, M.D., principal investigator).

  • Improving and reducing disparities in management of insomnia, pain, anxiety, depression, fatigue and physical dysfunction for patients with cancer in the Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial (UM1 CA233033, Andrea L. Cheville, M.D., principal investigator).

  • Research to inform best practices for tabulating and reporting the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) data, which will enable more systematic and patient-centered evaluations of drug tolerability in cancer clinical trials (U01 CA233046; Amylou C. Dueck, Ph.D., and other principal investigators).

  • Research in cardio-oncology, including TACTIC, a randomized trial assessing carvedilol as a cardioprotectant during and after HER2-directed cancer therapy (R01 CA233610; Kathryn J. Ruddy, M.D., and Joerg Herrmann, M.D., and other principal investigators).

  • Research in adolescent and young adult cancer survivorship, including as part of a multi-institutional assessment of clinical care gaps and unmet needs (P01 CA233432; Kathryn J. Ruddy, M.D., project co-leader).

  • A study in collaboration with Mayo Clinic Comprehensive Cancer Center's Hematologic Malignancies Program to systematically discover, validate and integrate tumor and host genetic biomarkers into actionable clinical information focused on early clinical failures in diffuse large B cell lymphoma, the most common non-Hodgkin lymphoma (R01 CA212162; James R. Cerhan, M.D., Ph.D., and other principal investigators).

  • Research on less-studied histological types of ovarian cancer that uses integrated analysis of multiple layers of information, including relationships between risk factors and genomic and prognostic associations, to provide powerful biological and mechanistic insight into ovarian cancer biology with potential to point to novel targeted therapeutic options (R01 CA248288; Ellen L. Goode, Ph.D., principal investigator).

  • Research to develop a highly accurate, automated and low-cost ctDNA test to monitor efficacy of treatment for patients with metastatic breast cancer by identifying the emergence of certain DNA mutations in plasma samples (75N91019C00035; Minetta C. Liu, M.D., principal investigator).

  • A population science project as part of the University of Iowa/Mayo Clinic Lymphoma SPORE to systematically discover, validate and integrate clinical, tumor and host genetic biomarkers into useful clinical information focused on early clinical failures in patients treated with immunochemotherapy (P50 CA097274 – Project 4; James R. Cerhan, M.D., Ph.D., co-leader).

  • Core infrastructure support for the Lymphoma Epidemiology of Outcomes (LEO), a cohort study of more than 16,000 patients with non-Hodgkin lymphoma with the goal of supporting broad and cutting-edge research that identifies clinical, epidemiologic (including lifestyle and other exposures), host genetic, tumor and treatment factors, and the interaction among these factors, on short- and long-term outcomes (2U01 CA195568; James R. Cerhan, M.D., Ph.D., and other principal investigators).

Recently published highlights related to Aim 3 include:

  • Biomarkers of ovarian reserve before and after oncologic treatment may help inform treatment decisions for patients with cancer who are in premenopause. Our researchers in interprogrammatic collaboration with Mayo Clinic Comprehensive Cancer Center's Women's Cancer Program published two critical papers in 2021 in this field. The first paper used menstrual data from the NSABP B47 trial to confirm that a lower prechemotherapy antimullerian hormone level is predictive of a higher likelihood of amenorrhea with two standard chemotherapies used to treat stage 1 to 3 breast cancer. This finding may influence how patients who are interested in future fertility are assessed soon after a cancer diagnosis. (Ruddy, et al., Antimullerian Hormone as a Serum Biomarker for Risk of Chemotherapy-Induced Amenorrhea. J Natl Cancer Inst. 2021 Aug 2;113(8):1105-1108. doi: 10.1093/jnci/djaa160.) The second paper reported on amenorrhea rates in TBCRC 033, the ATEMPT trial. Amenorrhea at 18 months was found to be less likely in recipients of the novel T-DM1 therapy than trastuzumab. These data will be important for counseling patients in premenopause who are considering treatment with either of these regimens. (Ruddy, et al. Chemotherapy-Related Amenorrhea (CRA) After Adjuvant Ado-Trastuzumab Emtansine (T-DM1) Compared to Paclitaxel in Combination with Trastuzumab (TH). Breast Cancer Res Treat. 2021 Aug;189(1):103-110. doi:10.1007/s10549-021-06267-8. Epub 2021 Jun 12.)

  • Program researchers were funded by the Cancer Moonshot Research Initiative, facilitating the development of a cluster-randomized trial to improve management of insomnia, pain, anxiety, depression, fatigue and physical dysfunction across the medical oncology practices at Mayo Clinic in Rochester and at Mayo Clinic Health System in the Midwest. An early paper from this project identified that only 39% of 1,204 symptom assessments on which at least 1 severe symptom was documented indicated receptivity to a nurse phone call to help with symptom management. The fact that many patients with severe symptoms were not receptive to a nurse phone call as part of this intervention means that better understanding of reasons for refusal and strategies for improving patient receptivity are needed. (Wintheiser, et al. Receptivity to a Nurse-Led Symptom Management Intervention Among Highly Symptomatic Patients With Cancer. J Natl Cancer Inst. 2021 Sep 11;djab172. doi:10.1093/jnci/djab172. Online ahead of print.)

  • Lymphedema is a feared complication of many local therapies (e.g., axillary node dissection) for cancer, and risk of lymphedema is greater in patients with obesity. Several researchers in our program published findings from a randomized cooperative group study to prevent lymphedema in women treated for breast cancer (CALGB 70305). In this clinical trial, exercise was tested as a potential prevention strategy for lymphedema by randomizing patients to a physical therapist-led exercise intervention (performed while wearing a compression garment) or to an education control arm. Lymphedema rates did not differ between the arms, but range of motion seemed to recover more quickly for participants in the exercise intervention arm. The poor adherence to the recommended exercises in the intervention arm and this study's failure to meet its primary endpoint suggest that alternative strategies are needed to reduce lymphedema in this population. (Paskett, et al. A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer: CALGB 70305 (Alliance). Cancer. 2021 Jan 15;127(2):291-299. doi:10.1002/cncr.33183. Epub 2020 Oct 20.)

  • Cancer-associated cachexia is common in patients with lung cancer. Program researchers led a pivotal study on cachexia by pooling weight change and survival data from patients with non-small-cell lung cancer from prospectively conducted trials within the Alliance for Clinical Trials in Oncology (1998-2008), including 656 patients with baseline and cycle 2 weight data available. Of these, 208 (32%) gained weight; 225 (34%) lost less than 2% of baseline weight; and 223 (34% of 656) lost 2% or more. Median survival from the beginning of Cycle 2 was 13.0, 10.9 and 6.9 months for patients with weight gain, weight loss of less than 2%, and weight loss of 2% or more, respectively. In multivariate analyses, adjusted for age, sex, performance score, type of treatment and body mass index, weight loss of 2% or more was associated with poor overall survival compared with weight gain [hazard ratio (HR) = 1.66; 95% confidence interval (CI): 1.33-2.07; P < 0.001] and compared with weight loss of less than 2% (HR = 1.57; 95% CI: 1.27-1.95; P < 0.001). Similar findings were observed in a separate 255-patient validation cohort, arguing that weight should be integrated into cancer cachexia trials because of its ease of frequent measurement and sustained prognostic association. (Le-Rademacher, et al. Weight Loss Over Time and Survival: A Landmark Analysis of 1000+ Prospectively Treated and Monitored Lung Cancer Patients. J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1501-1508. doi:10.1002/jcsm.12625. Epub 2020 Sep 17.)

  • Our researchers are national leaders in using informatics science to improve prognosis and other health outcomes. In a paper published in late 2020, a framework is presented for transforming free-text problem descriptions into standardized Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) models, which will greatly facilitate research using electronic health records. (Peterson, et al. A Corpus-Driven Standardization Framework for Encoding Clinical Problems with HL7 FHIR. J Biomed Inform. 2020 Oct;110:103541. doi:10.1016/j.jbi.2020.103541. Epub 2020 Aug 16.)