Symptom Research Observational Studies

2005-0380: Automated Pain Intervention for Underserved Minority Breast Cancer Patients

Principal Investigator: Tito Mendoza  ● Funding: American Cancer Society

Clinicaltrials.gov # NCT00881010

Ethnic minority patients who are underserved due to socioeconomic and health care system factors are especially vulnerable for inadequate pain management. A multifaceted approach that targets both patients and physicians may help to optimize pain treatment for these patients. Multicomponent interventions, however, are difficult to implement in large understaffed public hospitals that typically serve socioeconomically disadvantaged minority patients. In this study of underserved minority patients with breast cancer, we evaluate an interactive voice response (IVR) system that prompts health care providers to follow practice guidelines and alerts providers when pain is moderate to severe. The IVR system will also provide patients with individualized education on pain management that is designed to remove patient-related barriers to optimal pain control.

Primary Objectives: (1) To pilot test the efficacy of the IVR system for improving pain management and quality of life. (2) To pilot test the efficacy of the IVR intervention for improving pain-related symptoms (fatigue, sleep disturbance, sadness).

Secondary Objective: To evaluate the feasibility of an IVR intervention for pain management that targets both patients and their health care providers.

This study is ongoing but is not recruiting participants.

2005-0404: Effects of Cancer Symptoms on Caregivers

Principal Investigator:  Guadalupe Palos  ●  Funding: NCI K07 CA102482

Clinicaltrials.gov # NCT00351988

Minority patients are more likely than nonminority patients to present with advanced disease at diagnosis, which negatively affects treatment outcomes, survival rates, and quality of life. In turn, the strain of caring for a symptomatic cancer patient can negatively affect the health of that patient’s caregiver. When the patient is medically underserved, as is often the case for ethnic minority patients, the caregiver’s risk for increased difficulties and poor health outcomes increases. This study investigates how pain and other symptoms in medically underserved patients with advanced cancer (lung, breast, cervical, other solid tumors) affect the physical and psychological health of their caregivers over the course of the patient’s treatment.

Primary Objectives: (1) To identify and compare the experiences of minority and nonminority caregivers, including the prevalence and severity of physical (fatigue, sleep disturbance) and psychological (depression, anxiety, stress) symptoms and their influence on caregiver symptom burden. (2) To assess the relationship between caregiver symptoms (physical and psychological) and patient symptoms at multiple time points over the patient’s treatment regimen.

Secondary Objective: To describe the experience of being a minority (African American/Black or Latino) or nonminority person caring for a medically underserved patient with advanced cancer over the course of the patient’s treatment regimen and follow-up clinic visits.

This study is ongoing but is not recruiting participants.

2006-1038: Longitudinal Assessment of Arthralgias and Related Symptoms in Breast Cancer Patients Receiving Aromatase Inhibitors

Principal Investigator:  Charles Cleeland  ● Funding: AstraZeneca

Clinicaltrials.gov # NCT00738998

Aromatase inhibitors (AIs) are the preferred adjuvant treatment for postmenopausal women with early-stage hormone receptor-positive breast cancer. AIs are associated with side effects such as menopausal symptoms, vaginal dryness, sexual dysfunction, and musculoskeletal disorders such as arthralgia (joint pain), new-onset osteoporosis, and bone fractures.

In this study, we assess joint pain and other symptoms in breast cancer patients undergoing adjuvant treatment with anastrozole, a commonly used AI, longitudinally for 3 years from the beginning of treatment.  We estimate the incidence of joint pain and other joint symptoms during AI therapy, identify onset of these joint symptoms, and describe what methods of symptomatic relief are offered. With information from this study, clinicians should be able to better anticipate these events and provide better symptom management, potentially improving compliance with treatment.

Primary Objective: To longitudinally describe the incidence, clinical course, and treatment of joint pain and other treatment-related symptoms and the effects of these symptoms on continuation of therapy.

Secondary Objective: To identify risk factors and potential biological markers of joint pain and other treatment-related symptoms in these patients.

This study is ongoing but is not recruiting participants.

2007-0612: Identifying the Role of Inflammatory Cytokines in Symptom Production in Multiple Myeloma

Principal Investigator:  Xin Shelley Wang  ● Funding: AstraZeneca

Clinicaltrials.gov # NCT00688168

Many of the symptoms caused by multiple myeloma (MM) and its treatment may be caused by dysregulation of inflammatory cytokines and their precursors. Building on a large body of literature relating “sickness behavior” in animals (e.g., pain, sleep disorder, reduced appetite, decreased activity), we hypothesize that many MM-related and treatment-related symptoms might be improved by modulating inflammatory pathways. This study will address the link between changes in disease, the impact of therapy over time, and dynamic changes in cytokines and precursors, along with related symptom expression.

Primary Objectives: (1) To estimate the effects of novel induction agents on reducing MM-related symptoms and associated dynamic changes in cytokine levels. (2) To determine the course of the development of neuropathic pain caused by induction therapy and its association with inflammation markers in treatment-naïve patients with MM. (3) To study the association between cytokines and disease-driven symptom burden in treatment-naïve patients by examining serum cytokines and symptoms prior to cancer treatment, to further the development and interpretation of models correlating both disease-related and treatment-driven cytokines and symptoms. (4) To study the development of multiple symptoms in the acute phase of autologous stem cell transplantation and symptom severity as related to levels of serum inflammatory cytokines. (5) To track primary afferent function by quantitative sensory testing over time during chemotherapy. (6) To characterize neurocognitive and neuropsychiatric symptoms in patients with MM, using a neuropsychological test battery. (7) To evaluate symptom burden 1–5 years postdiagnosis for patients either receiving treatment or under observation only.

Secondary Objective: To analyze genetic variation from inflammation and other symptom-related genes with regard to risk for developing high symptom burden from MM and/or its treatment.

This study is ongoing but is not recruiting participants.

2007-0637: Prospective Study of Symptoms Related to Oxaliplatin-Based Regimens in the Treatment of Colorectal Cancer

Principal Investigator:  Xin Shelley Wang  ● Funding: AstraZeneca

Clinicaltrials.gov # NCT00777192

Oxaliplatin, a platinum-based chemotherapeutic agent that is combined with other chemotherapeutic agents for both first-line and salvage therapy for metastatic colorectal cancer, is associated with acute and chronic neuropathy. Whereas acute neuropathy typically resolves on its own several days after treatment stops, chronic neuropathy resulting from cumulative oxaliplatin treatment can be long lasting and problematic enough to be dose limiting for some patients, potentially affecting survival. In this study, we are conducting (1) a 12-month longitudinal study to gain a comprehensive understanding of oxaliplatin-induced neurotoxicity, cognitive impairment, and other symptoms experienced by patients with colorectal cancer and to investigate the potential role of inflammatory cytokines in producing such symptoms, and (2) a cross-sectional study to examine risk factors that may contribute to the development of high symptom burden during and after therapy for colorectal cancer.

Primary Objectives: (1) To identify the association between inflammatory markers and the development of treatment-related symptom burden (e.g., pain, neuropathy, fatigue, cognitive impairment). (2) To track primary afferent function by quantitative sensory testing over time. (3) To characterize neurocognitive and neuropsychiatric symptoms using a neuropsychological test battery at baseline and at selected follow-up points. (4) To evaluate the major symptom burden reported by patients during the first 5 years after diagnosis. (5) To analyze genetic variation from inflammation and other symptom-related genes with regard to risk for developing high symptom burden from cancer and therapy.

This study is ongoing but is not recruiting participants.

2008-0327: Identification and Treatment of Depression in Underserved African American and Latino Patients with Cancer

Principal Investigator:  Tito Mendoza  ● Funding: Robert Wood Johnson Foundation

Clinicaltrials.gov # NCT00863200

The prevalence of clinically significant depression in patients with cancer is estimated to be 15%–30% or higher, a rate 3–5 times greater than in the general population. Poorly managed depression is a major source of distress and impaired physical and social functioninfor patients and families. Depression can also result in the postponement or cessation of potentially curative therapies for cancer. Depression and depressive coping with cancer are significantly associated with shorter survival, independent of biomedical prognostic factors. When minority patients are underserved due to socioeconomic and health care system factors, they are even more vulnerable to inadequate identification and management of depression.

This project evaluates the feasibility and effectiveness of a novel computer-automated intervention for the assessment and treatment of depression that targets underserved minority patients and their providers.

Primary Objective: To evaluate the effectiveness of a telephone-based interactive voice response (IVR) alert intervention for improving treatment of depression in underserved African American and Latino patients with cancer.

Secondary Objective: To determine the utility of the IVR system for identifying clinically significant depression in underserved African American and Latino patients with cancer.

This study is ongoing but is not recruiting participants.

2008-0582: A Feasibility Study for Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients with Metastatic Pancreatic Cancer

Principal Investigator:  Xin Shelley Wang

Clinicaltrials.gov # NCT00805688

Pancreatic cancer is a highly symptomatic and rapidly lethal disease. Even small reductions in symptom burden and improvements in quality of life may do more for a pancreatic cancer patient’s well-being than an additional few weeks of survival.

Although a number of cross-sectional studies have investigated the symptoms of pancreatic cancer, little is known about their trajectories over the course of the disease or potential correlations between patient-reported symptoms and inflammation. Polymorphisms in single nucleotide polymorphisms in relevant genes coding for inflammatory cytokines or drug-metabolizing enzymes have been implicated in differences in symptom control, treatment effectiveness, and survival in other cancers. We hypothesize that symptom development in patients with advanced pancreatic cancer, as assessed with the MD Anderson Symptom Inventory (MDASI), a multisymptom patient-reported outcomes tool, will correlate with increasing levels of serum cytokines and tumor markers during disease progression.

Primary Objective: To determine the value of patient reported pain and other symptoms for predicting overall survival in patients with pancreatic cancer.

Secondary Objectives: (1) To categorize the longitudinal course of the multiple symptoms experienced by patients with metastatic pancreatic cancer. (2) To explore the relationships between cancer symptoms and polymorphisms of genes relating to inflammation, chemotherapeutic drugs, and opiate metabolism. (3) To explore the association of inflammatory cytokines with disease-driven symptom development and its predictive value for survival in these patients. (4) To evaluate the association between an objective measure of physical functioning (daily step count), patient-reported physical symptom severity, and physician-reported performance status.

This study is ongoing but is not recruiting participants.

2010-0020: Usability Testing of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Principal Investigator:  Tito Mendoza  ● Funding: NCI N02-PC-85002-29

This study is the usability testing component of the National Cancer Institute’s Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) initiative, which included creating/validating new adverse symptom items for use in NCI-sponsored trials; conducting cognitive interviews to ensure patient understanding of items; and developing a user interface to administer these items. Specifically, this protocol assesses the usability of the software system, including a website and an interactive voice response system.

In usability testing, people who are representative of future users interact with a product/system in a realistic environment that simulates “real world” use, in order to uncover problems, collect quantitative data on user performance (e.g., time to task completion, error rate), determine user satisfaction, and identify areas for improvement.

Primary Objective: To measure users’ ability to respond to PRO-CTCAE items safely, effectively, efficiently, and enjoyably, by (1) observing users interacting with the system, guided by “think aloud” protocols, and taking extensive field notes; and (2) gathering user feedback through brief semistructured interviews immediately after their use of the system.

This study is ongoing but is not recruiting participants.

2013-0335: Relationship Stress, Socioeconomic Status, and Inflammation: Pathways to Cancer-Related Fatigue

Principal Investigator:  Cobi Heijnen  ● Funding: PI Startup Funds

Fatigue is the most debilitating problem among cancer survivors post-treatment, yet the underlying causes of cancer-related fatigue are poorly understood. Patients who are of low socioeconomic status and/or are overweight are at especially high risk for cancer-related fatigue. In addition, the stress associated with a turbulent marriage can prime or sensitize the inflammatory stress response and increase cancer-related fatigue. Marital stress may be an important conduit through which low socioeconomic status and obesity are linked to cancer-related fatigue.

This pilot study evaluates the feasibility of a larger trial to assess changes in fatigue and proinflammatory cytokine production across the day after stressful marital interactions between breast cancer survivors and their spouses.

Primary Objective: To evaluate the feasibility of conducting 4 serial draws (1 before a stressor and 3 after) to assess proinflammatory cytokines over a 6-hour visit at MD Anderson.     

Secondary Objectives: (1) To estimate the average changes in inflammation and fatigue levels. (2) To evaluate the feasibility of administering nightly diaries to assess daily fatigue and stress. (3) To assess variables related to quality-of-life outcomes and predictors. 

This study is ongoing but is not recruiting participants.

2013-0573: Stress and Post-Treatment Immune Responses to the Influenza Vaccine: Implications for Cancer Health Disparities

Principal Investigator:  Cobi Heijnen  ● Funding: PI Startup Funds

The Centers for Disease Control and the American Cancer Society recommend that all cancer survivors receive the seasonal trivalent influenza virus vaccine, which reduces mortality rates and decreases the frequency and duration of hospital visits. Despite these recommendations, little is known about the extent to which the vaccine effectively protects against influenza in this vulnerable population. If the standard dosage of the influenza vaccine is ineffective, or if certain subgroups of cancer survivors are particularly vulnerable to inadequate antibody response, public health leaders will need to reevaluate current dosage recommendations. This study is being conducted in both breast cancer survivors (stages 0, I, II, IIIa) and noncancer patients.

Primary Objectives: (1) To evaluate the feasibility of conducting serial draws before and after the flu shot to assess the following factors: antibody titers to the influenza vaccination, inflammatory markers, antibody titers to Epstein-Barr virus, cytomegalovirus (as a marker of cellular immune dysregulation), and telomere length. (2) To assess demographic and psychosocial variables related to potential predictors for these factors. (3) To assess potential predictors for these factors. (4) To estimate average relationships (effect sizes) between potential psychosocial predictors (socioeconomic status, early life stress, social support) and these factors.

This study is ongoing but is not recruiting participants.

2014-0511: Exploring the Neuroimmune Basis of Cancer-Related Fatigue using Behavioral Measures

Principal Investigator:  Robert Dantzer  ● Funding: MD Anderson IRG

Clinicaltrials.gov # NCT02255773

Fatigue is a prominent symptom associated with head and neck cancer and its treatment. Cancer-related fatigue (CRF) develops into a chronic condition in a significant proportion of this population. A prominent aspect of CRF is decreased motivation, characterized by a diminished willingness to exert effort in order to obtain a goal; whereas habitual behavior is highly economical in terms of attentional processes and cognitive effort, goal-directed behavior requires sustained attention and constant adjustment in the nature and intensity of the behavioral response. Impaired ability to transition from the rigidity of habitual behavior to the flexibility of goal-directed behavior when the situation requires it might account for the symptom of cognitive confusion often reported by individuals suffering from CRF. Further, inflammation has been associated with fatigue in various disease conditions and with reduced motivation and depressive-like behavior in mice.

This study aims to objectively characterize neurobehavioral components of persistent CRF experienced by male head and neck cancer survivors and to elucidate the neuroimmunological mechanisms underlying these components. Validated computerized tasks are used to objectively assess motivation, learning of goal-directed and habitual behavior, and flexibility to switch between behavioral strategies. Insight into the neuroimmunological mechanisms related to these behavioral alterations may inform the development of novel therapeutic targets for interventions aimed at preventing or treating CRF.

Primary Objective: To determine whether cancer survivors with moderate to severe CRF who have been treated for head and neck cancer are impaired in their self-motivation, ability to learn new behaviors, and ability to switch between behavior strategies.

Secondary Objectives: (1) To evaluate the association between markers of inflammation/cellular damage, self-reported fatigue, and self-motivation and/or the ability to acquire and switch between behavior strategies. (2) To explore the extent to which individual differences in self-reported fatigue, self-motivation, and the ability to acquire and switch between behavior strategies can be explained by individual variations in the Val158Met alleles of the catechol-O-methyltransferase (COMT) gene and in the Variable Number Tandem Repeats (VNTR) in the 3’ untranslated region of the dopamine active transporter 1 (DAT1) gene. (3) To explore clinical and treatment-related factors for their impact on fatigue and behavior.

This study is ongoing but is not recruiting participants.

2015-0500: Using Biobehavioral Measures to Explore the Neuroimmune Basis of Cancer-Related Fatigue

Principal Investigator:  Robert Dantzer  ● Funding: MD Anderson IRG

Fatigue is a prominent symptom associated with cancer and its treatment. Fatigue develops into a chronic condition in a significant proportion of the cancer population. This study aims to objectively characterize neurobehavioral components of persistent fatigue (hereafter referred to as cancer-related fatigue, or CRF) experienced by cancer survivors and to elucidate their neuroimmune mechanisms.

Primary Objective: To determine whether cancer patients with fatigue are impaired in their motivation and their ability to switch between behavioral strategies.

Secondary Objectives: (1) To evaluate the association between markers of inflammation/cellular damage, self-reported fatigue, self-motivation, and the ability to switch between behavioral strategies. (2) To explore the extent to which individual differences in self-reported fatigue, self-motivation, and the ability to acquire and switch between behavioral strategies can be explained by individual variations in the alleles of the catechol-O-methyltransferase (COMT) gene, where valine is replaced by methionine at position 158 in the gene (i.e., Val158Met), and in the Variable Number Tandem Repeats (VNTR) in the 3’ -untranslated region (3'-UTR) of the dopamine active transporter 1 (DAT1) gene. (3) To explore clinical and treatment-related factors for their impact on fatigue and behavior.

This study is ongoing but is not recruiting participants.

DR10-0984: Symptom Patterns in Treatment-Naïve Patients with Head and Neck Cancer

Principal Investigator:  Tito Mendoza

The symptom burden associated with newly diagnosed head and neck cancer prior to any cancer-related therapy has not been well studied. Documenting the presenting symptoms of patients with head and neck cancer will facilitate referral for further care or follow up if needed. In this study, we analyze patient-reported symptoms in patients with newly diagnosed, untreated head and neck cancer. Our ultimate goals are to gain a better understanding of the prevailing symptom patterns experienced by these patients and to lay a foundation for the design of future symptom-intervention strategies and prospective clinical investigations.

Primary Objectives: (1) To assess the severity of symptoms reported by patients with previously untreated head and neck cancer, in order to compare symptom burden across various cancer subsites. (2) To determine potential relationships between patient-reported symptom data and corresponding patient data, including demographic data and clinical information on initial diagnosis.

This study is ongoing but is not recruiting participants.

PA13-0339: Integrated Program in Toxicity Genomics in Patients Treated for Acute Myelogenous Leukemia/Myelodysplastic Syndrome

Principal Investigator: Dimitrios Kontoyiannis; Collaborator: Cobi Heijnen  ● Funding: MD Anderson Moon Shot Knowledge Gap

The goal of this study, which is part of the MD Anderson Moon Shot Knowledge Gap, is to develop critical preliminary data to be competitive for the external funding needed to develop a large-scale program in understanding how to prevent and treat cancer-related and treatment-related toxicities. We hypothesize that the combination of host genomic factors in specific inflammatory pathways, together with cancer therapy-induced changes in the host microbiome, determine the severity of cancer therapy-induced fatigue and other behavioral toxicities. This pilot study is being performed in patients with acute myelogenous leukemia/myelodysplastic syndrome (AML/MDS) undergoing induction remission chemotherapy.

Primary Objectives: (1) To relate serial changes in the gastrointestinal microbiome to the occurrence of gram-negative septicemia (gram-negative bacterial infection and the intestinal microbiome). (2) To relate whole genome content of viridans group streptococci (VGS) to the severity of VGS bloodstream infection (streptococci and pathogen genetics). (3) To determine whether there is a relationship between host fibrinogen polymorphisms and development of staphylococcal catheter-related bloodstream infections (staphylococci and host genetics). (4) To determine if there is an association between cytokine levels, genetic polymorphisms in inflammatory pathways, and the development of behavioral toxicities during induction remission chemotherapy for AML/MDS (behavioral toxicity, inflammation, and host genetic factors). (5) To correlate changes in the host microbiome to inflammatory cytokine levels and the development of behavioral toxicities in AML/MDS patients (behavioral toxicity, inflammation, and the host microbiome). 

This study is ongoing but is not recruiting participants.

PA15-0685: Parkinson Patients Serum Samples

Principal Investigator:  Cobi Heijnen  ● Funding: Parkinson’s Foundation, PI Startup Funds

Although fatigue has been well-studied in cancer, less is known about fatigue in Parkinson disease. Parkinson-related fatigue, which includes motivational deficits, anxiety, sadness, and trouble concentrating or thinking, differs from normal post-exertion fatigue, typically described as physical exhaustion or sleepiness. The extent to which the incidence and prevalence of fatigue among Parkinson survivors differs from similar adults without a Parkinson history is not well understood.

In general, depressive symptoms are the strongest predictor of fatigue, and the ties between depression and fatigue are of particular concern given the relative prevalence of depression in Parkinson patients. The focus of this proposal is on inflammation and its association with depression and Parkinson-related fatigue; this is a prospective study of serum specimen collected at an outside institution.

Primary Objective: To assess the association between inflammation and fatigue cross-sectionally at various time points, as well as the extent to which higher levels of inflammatory markers at initial diagnosis predict subsequent fatigue.

Secondary Objective: To evaluate relationships between past or current syndromal depression and/or depressive symptoms and inflammatory markers, nuclear factor-kB activation, and fatigue, as well as their association with subsequent inflammation and fatigue.

PA15-0704: Marital Hostility, Autonomic Activity, Inflammation, and Quality of Life: A Dyadic Approach

Principal Investigator:  Cobi Heijnen

The first two years of the survivorship period requires management of ongoing physical symptoms and fears of recurrence that necessarily involve the spouse. Cancer survivors and spousal caregivers often report congruent levels of psychological distress and symptom burden. Accordingly, when the spousal relationship is troubled (as reflected by hostile marital interactions), this may increase the psychological and physiological burden on both members of the dyad. Marital hostility has been associated with key physiological markers that underlie symptom burden, such as inflammation, dysregulation of the hypothalamic–pituitary–adrenal axis, and autonomic nervous system activity. To help manage symptoms effectively, we must better understand predictors of symptoms and symptom clusters at a dyadic level.

Primary Objective: To assess whether marital hostility dysregulates autonomic, neuroendocrine, and inflammatory activity in breast cancer survivors and their spouses differently than it does in age-matched female controls and their spouses.

PA15-0745: Project Heart: Biobehavioral Effects on Cardiovascular Risk for Bereaved Spouses

Principal Investigator:  Cobi Heijnen  ● Funding: NIH R01 Subcontract, PI Startup Funds

The loss of a spouse is a highly stressful event that increases the risk for morbidity (including cardiovascular disease, stress, anxiety, and depression) and even mortality. Psychological stress and depression enhance promotion of proinflammatory cytokines. Inflammation is central to all stages of cardiovascular disease, from initial lesion to end-stage thrombotic complications. Attachment theory may explain individual differences in people’s ability to adjust to the loss of a loved one: people with high attachment anxiety use hyperactivating emotional coping strategies, whereas people with high attachment avoidance are uncomfortable depending on others for support and use coping strategies that inhibit or suppress distressing experiences. Individual differences in attachment style may be prognostic for who is most at risk for enhanced inflammation and ultimately cardiovascular disease after the loss of a spouse.

Primary Objective: To determine if bereavement enhances inflammation after the loss of a spouse in a demographically diverse sample of bereaved individuals and controls, and to evaluate the time frame for these changes.

Secondary Objectives: (1) To assess the extent to which bereavement modulates typical stress-related increases in cytokine production. (2) To evaluate associations between attachment insecurity, depressive symptoms, and inflammation and to compare the magnitude of these associations in bereaved individuals versus age-matched non-bereaved individuals (who are married or have been cohabitating with a partner for at least 3 years).

PA15-1060: Symptom Patterns at Presentation to MD Anderson Cancer Center: Effects of Prior Cancer Treatment

Principal Investigator:  Charles Cleeland

Although several studies have examined symptom burden in patients with cancer before and during  treatment, literature on the symptom burden experienced by patients with newly diagnosed cancer, prior to any cancer-related therapy (i.e., disease-related symptoms), is lacking. Data capture based on the MD Anderson Symptom Inventory (MDASI) portion of the MD Anderson Patient History Database (PHDB) provides an excellent avenue for examining patient-reported symptoms (severity, incidence, and prevalence) in newly diagnosed and untreated patients with cancer in our institution.

The goals of this protocol are to characterize the prevailing symptom patterns experienced by treatment-naïve patients with cancer, to generate disease-related symptom patterns that will serve as target outcomes for toxicity evaluation once treatment begins, and to lay a foundation for the design of future symptom-intervention strategies and extramurally funded prospective clinical investigations. We will compare results from these patients with results from patients who had previous therapy.

Primary Objectives: (1) To assess the severity of symptoms reported by cancer patients newly referred to MD Anderson, in order to identify and compare symptom burden across various cancer sites and between patients who are treatment naïve and those who were treated previously. (2) To determine, in patients with previously untreated cancer, potential relationships between patient-reported symptom data and corresponding patient data (e.g., demographic data, clinical information on initial diagnosis and survival). (3) To determine, in patients with previously treated cancer, potential relationships between patient-reported symptom data and corresponding patient data (e.g., demographic data, clinical information on initial diagnosis, previous treatments, and survival).

PA16-0185: Establishing Clinically Meaningful Interpretation for the MD Anderson Symptom Inventory in Clinical Research

Principal Investigator: Qiuling Shi

This study characterizes patient-reported functional status in cancer survivors using data derived from the Eastern Cooperative Oncology Group (ECOG) E2Z02 Symptom Outcomes and Practice Patterns study, which included 3,123 cancer patients, with 1,332 no-evidence-of-disease survivors, from 38 health care institutions. Patients rated the severity of their cancer symptoms and the degree to which these symptoms interfered with daily functioning, using a multisymptom patient-reported outcomes (PRO) instrument, the MD Anderson Symptom Inventory (MDASI).  

Primary Objectives: (1) To develop a clinically meaningful interpretation of PRO-based (MDASI) symptom and functional-status results and to provide a normative profile for symptom burden in patients with cancer. (2) To provide essential parameters for using PRO-based measures in clinical research and to facilitate integration of PRO-based measures in decision making and in future clinical trials.

This study is ongoing but is not recruiting participants.

PA13-0568: Changes in Symptoms and Inflammatory Markers During Treatment with Ruxolitinib

Principal Investigator: Charles Cleeland

Under this protocol, members of the Department of Symptom Research mentor analysts at the Mayo Clinic about the modeling techniques needed to examine the association between inflammatory markers and symptoms.