Capturing the patient's experience: using qualitative methods to develop a measure of patient-reported symptom burden: an example from ovarian cancer.

CONTEXT: Experts in patient-reported outcome (PRO) measurement emphasize the importance of including patient input in the development of PRO measures. Although best methods for acquiring this input are not yet identified, patient input early in instrument development ensures that instrument content captures information most important and relevant to patients in understandable terms. OBJECTIVES: The M. D. Anderson Symptom Inventory (MDASI) is a reliable valid PRO instrument for assessing cancer symptom burden. We report a qualitative (open-ended, in-depth) interviewing method that can be used to incorporate patient input into PRO symptom measure development, with our experience in constructing an MDASI module for ovarian cancer (MDASI-OC) as a model. METHODS: Fourteen patients with ovarian cancer (OC) described symptoms experienced at the time of the study, at diagnosis, and during prior treatments. Researchers and clinicians used content analysis of interview transcripts to identify symptoms in patient language. Symptoms were ranked on the basis of the number of patients mentioning them and by clinician assessment of relevance. RESULTS: Forty-two symptoms were mentioned. Eight OC-specific items will be added to the 13 core symptom items and six interference items of the MDASI in a test version of the MDASI-OC on the basis of the number of patients mentioning them and clinician assessment of importance. The test version is undergoing psychometric evaluation. CONCLUSION: The qualitative interviewing process, used to develop the test MDASI-OC, systematically captures common symptoms important to patients with OC. This methodology incorporates the patient experience recommended by experts in PRO instrument development.

Anastrozole-associated joint pain and other symptoms in patients with breast cancer.

UNLABELLED: More than a third of breast cancer patients undergoing aromatase inhibitor (AI) treatment report joint pain. We conducted a longitudinal study to characterize the course of AI-induced joint pain and other symptoms and to identify potential predictors for developing these symptoms. Patients were recruited before AI initiation. The Brief Pain Inventory, M. D. Anderson Symptom Inventory, and a joint-pain questionnaire were administered at baseline and then biweekly for 1 year. Analysis included logistic regression, Cox models, and mixed-effects models. Of 47 patients assessed, 16 (34%) reported joint pain at least once. Median time to first report of joint pain was 7 weeks (range, 1-38). Baseline pain was the only predictor for both incidence of joint pain and time to first event. In the first 6 weeks, emergence of joint pain was associated with increase in general pain, fatigue, disturbed sleep, hot flashes, vaginal dryness, and decreased sexual activity. After week 6, having joint pain was associated with increase in general pain and with persistently high fatigue. Having AI-associated joint pain correlated with increase in or persistence of other symptoms likely related to AI therapy. Further research is needed to validate predictors of AI-associated symptoms. PERSPECTIVE: We demonstrate for the first time that AI-induced joint pain associates with development of other symptoms and that pretreatment pain level is a potential, measurable predictor of symptom development during treatment. Because baseline pain is easily assessed with a brief questionnaire, it can be applied clinically with minimal patient burden.

Acute and late onset cognitive dysfunction associated with chemotherapy in women with breast cancer.

BACKGROUND: Growing evidence supports cognitive dysfunction associated with standard dose chemotherapy in breast cancer survivors. We determined the incidence, nature, and chronicity of cognitive dysfunction in a prospective longitudinal randomized phase 3 treatment trial for patients with T1-3, N0-1, M0 breast cancer receiving 5-fluorouracil, doxorubicin, and cyclophosphamide with or without paclitaxel. METHODS: Forty-two patients underwent a neuropsychological evaluation including measures of cognition, mood, and quality of life. Patients were scheduled to be assessed before chemotherapy, during and shortly after chemotherapy, and 1 year after completion of chemotherapy. RESULTS: Before chemotherapy, 21% (9 of 42) evidenced cognitive dysfunction. In the acute interval, 65% (24 of 37) demonstrated cognitive decline. At the long-term evaluation, 61% (17 of 28) evidenced cognitive decline after cessation of treatment. Within this group of patients, 71% (12 of 17) evidenced continuous decline from the acute interval, and, notably, 29% (5 of 17) evidenced new delayed cognitive decline. Cognitive decline was most common in the domains of learning and memory, executive function, and processing speed. Cognitive decline was not associated with mood or other measured clinical or demographic characteristics, but late decline may be associated with baseline level of performance. CONCLUSIONS: Standard dose systemic chemotherapy is associated with decline in cognitive function during and shortly after completion of chemotherapy. In addition, delayed cognitive dysfunction occurred in a large proportion of patients. These findings are consistent with a developing body of translational animal research demonstrating both acute and delayed structural brain changes as well as functional changes associated with common chemotherapeutic agents such as 5-fluorouracil.