Symptom Research Instrument Development

BS99-094: Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System

Principal Investigator: Loretta Williams  ● Funding: Industry

Clinicaltrials.gov # NCT00505245

The symptoms of cancer and cancer treatment significantly impair patient functioning and quality of life. Despite the tremendous impact that symptoms can have on patient well being, healthcare professionals may wait until patients spontaneously complain of symptoms before formally assessing them and are more apt to rely on their own experience or professional judgment than to utilize a standard and valid patient-reported outcomes (PRO)-based assessment tool.

In this protocol, we continue to develop and test the utility of the MD Anderson Symptom Inventory (MDASI), its various site-specific and treatment-specific modules, and other MD Anderson-developed PRO instruments. We also focus on symptom assessment and how symptoms affect quality of life. We will explore the feasibility of creating symptom-management pathways using these data. The development of new instruments, including MDASI modules, under this protocol is done in accordance with guidance from the US Food & Drug Administration on the development of PROs for use in drug trials to support labeling claims.

Primary Objective: To develop MD Anderson Inventory (MDASI) modules and other PRO instruments and to examine how they perform in various sample populations, including community dwelling adults and patients who have different cancer types, who have undergone various treatments, and who have different and/or more severe symptoms.

Secondary Objectives: (1) To evaluate the MDASI or other MD Anderson-developed PRO instrument as an estimate of functional status and quality of life. (2) To assess the impact of symptom severity on standard function and health-related quality of life measures, including both quantitative and qualitative measures (patient interviews). (3) To assess the pattern and severity of symptoms over multiple time points in order to assay the system’s responsiveness to changes caused by therapy or disease. (4) To explore the utility of an interactive voice response (IVR) system for enhancing the clinical care of outpatients. (5) To explore the effect of information from an IVR symptom assessment system on patterns of care and the development of interdisciplinary protocols. (6) To explore the feasibility of developing symptom management pathways for patients based on these symptom and quality-of-life data.

2004-0598: The Brief Sleep Disturbance Scale: Measuring Sleep Disturbance Among Cancer Patients

Principal Investigator: Tito Mendoza 

Clinicaltrials.gov # NCT00505544

The purpose of this study is to evaluate the reliability and validity of the Brief Sleep Disturbance scale (BSDS), a patient-report measure designed to screen for sleep disturbance among individuals with cancer. Having a brief, reliable, valid sleep measure for cancer patients will allow the longitudinal study of sleep problems and the evaluation of effective treatment strategies. BSDS scores from cancer patients will be compared with those from a community sample.

Primary Objectives: (1) To establish the concurrent criterion-related validity of the BSDS by correlating the scale with the Pittsburgh Sleep Quality Index. (2) To evaluate the construct validity of the BSDS through exploratory factor analysis. (3) To examine possible predictors of sleep disturbance. (4) To evaluate the reliability of the BSDS using Cronbach’s coefficient alpha and test-retest reliability. (5) To evaluate the sensitivity of the BSDS by administering it to the same group of patients prior to treatment with a regimen associated with sleep disturbance, during 4 weeks of treatment, and upon completion of treatment. (6) To evaluate the psychometric properties of the BSDS in a sample of community dwelling adults.

Secondary Objective: To obtain pilot data from a small sample of patients who will wear an actigraph for 1 week.

This study is ongoing but is not recruiting participants.

2009-0268: Validation Study of a Spanish Version of the Brief Fatigue Inventory (BFI-Sp) and the MD Anderson Symptom Inventory (MDASI-Sp)

Principal Investigator: Guadalupe Palos 

Common symptoms of cancer and cancer treatment significantly impair patient functioning and quality of life. If symptom management is to be improved, it is necessary to obtain data on symptom prevalence, severity, and impact on daily activities. It is also necessary to be able to document the effectiveness of various treatments, educational programs, and policy changes that intend to improve symptom management.

The current status of symptom management for cancer has been studied only partially in Spanish-speaking nations. The goal of this study is to psychometrically validate two Spanish-language symptom assessment instruments developed by the Department of Symptom Research, the Brief Fatigue Inventory (BFI) and the MD Anderson Symptom Inventory (MDASI), in order to establish instruments that are sensitive, reliable, and valid for use in cancer clinical trials in Spanish-speaking South American patients. These instruments will be validated in patients treated at the Arturo Lopez Perez Cancer Center in Santiago, Chile.

Primary Objectives: (1) To validate a Spanish version of the BFI in patients who have different degrees of cancer-related fatigue. (2) To validate a Spanish version of the MDASI in patients with different cancer types, who have undergone various treatments, and who have different levels of severity of cancer-related symptoms.

Secondary Objectives: (1) To utilize the newly validated instruments to study symptom prevalence, symptom severity, and symptom interference in these patients. (2) To determine the test–retest reliability of the instruments in a sample of patients receiving radiotherapy and/or chemotherapy.

This study is ongoing but is not recruiting participants.

2009-0882: Assessing Prostate Cancer Symptoms and Symptom Burden in Multi-Ethnic Men

Principal Investigator:  Guadalupe Palos

Symptoms associated with prostate cancer may be caused by the disease itself or by the toxicities related to the treatment regimen. Although the significant impact of these symptoms on patient quality of life is becoming increasingly clear, the effects of symptoms related to localized and metastatic prostate cancer and their treatment are often underestimated by physicians and other clinicians. Consequently, the patient’s self-report of the symptom experience and its impact on their quality of life is the best way to assess the symptom experience.

Primary Objectives: (1) To develop and psychometrically validate the MD Anderson Symptom Inventory prostate cancer module for use in clinical research and patient care. (2) To provide symptom profiles and symptom burden data (severity, interference with functioning) in patients with prostate cancer receiving various types of treatment.

Secondary Objective: To describe the symptom experience of racially diverse men (African-American, Asians, Latinos, and Caucasians) with prostate cancer.

This study is ongoing but is not recruiting participants.

2010-0267: Symptom Burden in Patients with Gastrointestinal Stromal Tumors

Principal Investigator:  Loretta Williams  ● Funding: Novartis

Clinicaltrials.gov # NCT01178307

Common symptoms of gastrointestinal stromal tumors (GISTs), such as gastrointestinal bleeding, abdominal pain, fatigue, nausea and vomiting, and difficulty swallowing, may contribute significantly to the burden of the disease. Because of their exophitytic growth pattern, GISTs can cause symptoms that are not always typical of gastrointestinal cancers, and the responses of GISTs to therapy can be difficult to assess with imaging techniques. There is little research on the symptoms experienced by patients with GISTs and their impact on daily functioning to direct interventions that may assist patients in returning to normal. A valid measure of the symptom burden of GIST and its treatment will improve the ability of clinicians to care for patients with GISTs, including making decisions about continuing or changing treatments. The goal of this study is to develop a valid and reliable measure of the symptom burden experienced by patients with GISTs and to delineate this burden over time.

Primary Objective: To develop and validate an MD Anderson Symptom Inventory module (the MDASI-GIST) to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with GISTs.

Secondary Objectives: (1) To develop a detailed description of the severity and interference with daily activities of symptoms experienced by these patients. (2) To assess the impact of symptom severity on standard function and quality of life (QOL) measures including both quantitative (ECOG Performance Status and single-item QOL scales) and qualitative measures (patient interviews). (3) To evaluate the MDASI-GIST as an estimate of functional status and QOL. (4) To identify common clusters of symptoms and symptom patterns occurring over multiple measurement time points. (5) To define the qualitative symptom experience of these patients. (6) To explore the feasibility of an interactive voice response system for measuring symptom severity and interference with daily activities over time.

This study is ongoing but is not recruiting participants.

2012-0033: Assessing Cervix Cancer Symptoms and Symptom Burden in Multi-Ethnic Women

Principal Investigators: Lois Ramondetta, Qiuling Shi

Comprehensive assessment of the physical, affective, and cognitive symptoms associated with cervix cancer and its treatment may help direct interventions that may decrease symptom burden and improve quality of life and daily functioning for patients. The purpose of this study is to delineate and measure the symptom burden experienced by patients with cervix cancer, including pain, nausea, distress, body image changes, sexual dysfunction, proctitis, cystitis, vaginal agglutination, fatigue, and diarrhea.

Primary Objective: To develop and validate a cervix cancer module of the MD Anderson Symptom Inventory (MDASI-CX) to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with cervix cancer.

Secondary Objectives: (1) To assess the impact of symptom severity according to standard functioning and quality-of-life measures. (2) To develop a qualitative description of symptom severity and symptom interference with daily activities experienced by racially and ethnically diverse patients with cervix cancer. (3) To validate a Spanish version of the MDASI-CX.

2012-1045: A Comparison Study to Cross-Validate the LASA, PROMIS, and PRO-CTCAE in Assessing Cancer Patient Well-being

Principal Investigator: Tito Mendoza; Grant PI: Charles Cleeland  ● Funding: NIH R01 CA026582

Clinicaltrials.gov # NCT00505245

Capturing the patient’s perspective of well-being effectively and efficiently is critical to designing and evaluating interventions to ameliorate the impact of cancer and its treatments. At present, there is little information on the relative merits of the available patient-reported outcomes (PRO) measures and a lack of consensus on how to best select and deploy them. Through the Patient-Reported Outcomes Measurement Information System (PROMIS) and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) initiatives, the National Institutes of Health has made a major investment in the development and standardization of PRO measurement. However, few large-scale prospective assessments of the PROMIS measures have been undertaken among cancer patients, and no studies have directly compared the psychometric and prognostic properties of the PROMIS measures to the newly developed PRO-CTCAE and other brief measures such as the Linear Analogue Self-Assessment (LASA). This protocol brings together a multi-disciplinary team of investigators to leverage the investment in PROMIS and PRO-CTCAE and extend prior work on assessing symptoms, toxicity, and quality of life in cancer patients.

Primary Objective: To assess the convergent validity of each PRO-CTCAE, LASA, and PROMIS item by comparing each item by good-vs-poor performance status at baseline.  Convergent validity will be further assessed by repeating the primary analysis at the longitudinal time point, by assessing the correlation among the various PRO measures of each symptom, and by comparing selected symptoms between groups of patients as defined by disease type and clinical anchors.

Secondary Objectives: (1) To assess the responsiveness (sensitivity to change) and clinical significance of each PRO-CTCAE item by comparing change scores within groups of patients as defined by the patient responses to global impression of change items. (2) To estimate the minimally important differences of the various PRO measures for varying disease types and patient subgroups as well as overall. (3) To compare the relative prognostic power of each PRO item for overall survival, disease-free survival, and progression-free survival. (4) To describe and compare the agreement of responses between pairs of modes, via the intra-class correlation coefficient (for ordinal responses) and kappa (for nominal responses).

This study is ongoing but is not recruiting participants.

2015-0271: Preliminary Testing of the MD Anderson Symptom Inventory (Adolescent Version)

Principal Investigator: Loretta Williams  ● Funding: Genentech

Clinicaltrials.gov # NCT02515383

The goal of this study is to measure and delineate the symptom burden experienced by adolescent patients with cancer, using a modified version of the MD Anderson Symptom Inventory (MDASI). We modified one MDASI symptom interference item (Work (including work around the house)) to wording more appropriate to activities of adolescents (Work (including school work and chores)) to form the MDASI (adolescent version). “Symptom burden” is defined as the impact of symptoms on the ability of patients to function as they did prior to becoming ill or undergoing treatment, and it includes both the severity of symptoms experienced by patients and the degree to which these symptoms interfere with daily activities.

Primary Objective: To examine how the MDASI as modified for use with adolescents performs in adolescent patients who have various cancer types, who have undergone various treatments, and who have varying levels of symptom burden.

Secondary Objectives: (1) To explore the feasibility of various methods for collecting MDASI (adolescent version) data (for example, paper-and-pencil forms, face-to-face and telephone interviews, electronic data capture methods such as electronic tablets or automated telephone systems). (2) To evaluate the MDASI (adolescent version) as an estimate of functional status and quality of life in adolescent cancer patients.

PA13-0476: Retrospective Analysis of the Alopecia Areata Registry Symptom Data

Principal Investigator:  Tito Mendoza  ● Funding: National Alopecia Areata Foundation

Alopecia areata is a nonscarring, recurrent, and, at times, untreatable disease in which hair follicles surrounded by lymphocytes have abnormal keratinocyte differentiation, resulting in breakage of antigen hairs and in baldness. Patients with alopecia areata believe that their illness has strongly affected their lives and their self-esteem, and they have higher risk for developing psychiatric comorbidities, including high rates of depression and generalized anxiety disorder. This is a retrospective study of patient data from the Alopecia Areata Registry.

Primary Objective: To describe the severity of symptoms in patients with alopecia areata.

Secondary Objective: To validate the Alopecia Areata Symptom Impact Scale (AASIS).