Factors affecting symptom presentation in an early-phase clinical trials clinic patient population.

Increasing numbers of oncology therapies are being approved based on early-phase single-arm studies. Yet, little is known regarding the use of patient-reported outcomes in single-arm oncology trials testing novel therapies. We examined patient-reported symptom severity and symptom interference with activity- (WAW: work, general activity, walking) and mood-(REM: relations with others, enjoyment of life, mood) related functioning, and their association with factors known to influence symptom severity reporting, in early-phase clinical trials clinic patients. Patients completed the validated MD Anderson Symptom Inventory, containing 13 severity items and six interference items, each rated on a 0-10 scale (higher scores = worse symptom severity/interference). Performance status (ECOG-PS) and age were ascertained. Multiple linear regression was performed. In 248 phase I patients (51% female, 90% ECOG 0-1, and 74% ≤65 years), 67% of patients had ≥seven concurrent symptoms of any severity level, and 51% of patients described ≥three concurrent symptoms as moderate-to-severe (severity rating ≥ 5). Composite symptom severity, WAW and REM were worse in patients with ECOG-PS ≥ 2 vs. 0-1, and worse in patients with ECOG-PS = 1 than in patients with ECOG-PS = 0. Compared with patients over 65y, adolescent and young adult (AYA) patients (18y-39y) and patients aged 40y to 65y had worse composite symptom severity. As expected, being employed full-time/retired was associated with better symptom profiles in phaseI patients. The variation of symptom burden by performance status and age suggest that these factors need to be considered in the design of early-phase trials, particularly if patient-reported symptoms are used as primary/secondary/exploratory endpoints.

Cancer-Related Internet Use and Its Association With Patient Decision Making and Trust in Physicians Among Patients in an Early Drug Development Clinic: A Questionnaire-Based Cross-Sectional Observational Study.

BACKGROUND: The role of cancer-related internet use on the patient-physician relationship has not been adequately explored among patients who are cancer-related internet users (CIUs) in early-phase clinical trial clinics. OBJECTIVE: We examined the association between cancer-related internet use and the patient-physician relationship and decision making among CIUs in an early drug development clinic. METHODS: Of 291 Phase I clinic patients who completed a questionnaire on internet use, 179 were CIUs. Generations were defined by the year of patient's birth: "millennials" (after 1990) and "Generation X/Y" (1965-1990) grouped as "Millennials or Generation X/Y"; "Baby Boomers" (1946-1964); and "Greatest or Silent Generation" (1945 and earlier). Statistical analyses included the Wilcoxon matched-pairs signed-rank test and the Mann-Whitney U test. RESULTS: CIUs were 52% (94/179) female, 44% (78/179) were older than 60 years, and 60% (108/179) had household incomes exceeding US $60,000. The sources of information on cancer and clinical trials included physicians (171/179, 96%), the internet (159/179, 89%), and other clinical trial personnel (121/179, 68%). For the overall sample and each generation, the median values for trust in referring and Phase I clinical trial physicians among early drug development clinic CIUs were 5 on a 0-5 scale, with 5 indicating "complete trust." CIUs' trust in their referring (5) and phase 1 (5) physicians was higher than CIUs' trust in Web-based cancer-related information (3; P<.001 for both). CIUs who reported visiting the National Cancer Institute (NCI) website, NCI.org, to learn about cancer reported higher levels of trust in Web-based cancer-related information than CIUs who did not use the NCI website (P=.02). Approximately half of CIUs discussed internet information with their doctor. Only 14% (23/165) of CIUs had asked their physician to recommend cancer-related websites, and 24% (35/144) of CIUs reported at least occasional conflict between their physician's advice and Web-based information. CONCLUSIONS: Despite the plethora of websites related to cancer and cancer clinical trials, patients in early-phase clinical trial settings trust their physicians more than Web-based information. Cancer-related organizations should provide regularly updated links to trustworthy websites with cancer and clinical trial information for patients and providers and educate providers on reliable cancer websites so that they can better direct their patients to appropriate internet content.

Sleep quality and its association with fatigue, symptom burden, and mood in patients with advanced cancer in a clinic for early-phase oncology clinical trials.

BACKGROUND: Limited data exist about sleep quality for patients with advanced cancer in phase 1 clinical trials. Poor sleep quality is often not captured as an adverse event, and its association with fatigue, one of the most frequently reported adverse events, is not documented routinely. This article describes sleep quality and its relation with fatigue, symptom burden, and mood in patients recruited from an early-phase clinic for targeted therapy. METHODS: Sleep, fatigue, symptom burden, and mood were assessed with the Pittsburgh Sleep Quality Index (PSQI), the Brief Fatigue Inventory, the MD Anderson Symptom Inventory (MDASI), and the Brief Profile of Mood States, respectively; the Eastern Cooperative Oncology Group (ECOG) performance status (PS) was determined from medical records. RESULTS: The sample (n = 256) was 51.2% female, 90% had an ECOG PS of 0 or 1, and the mean age was 58 ± 0.8 years. Poor sleepers (global PSQI score > 5) constituted 64% of the sample. In separate multiple regression models, poor sleepers had higher levels of fatigue (P < .001), symptom burden (P < .001), and overall mood disturbance (P < .001) than good sleepers. Also, compared with good sleepers, poor sleepers had greater fatigue-related and symptom-related interference with daily activities (all P values < .001). The MDASI disturbed-sleep item correlated well with the global PSQI score (Pearson's r = 0.679, P < .001), and this suggests its usefulness as a patient-reported outcome screener of sleep quality in early-phase clinical trials clinics. CONCLUSIONS: Poor sleep quality was a significant problem in the current study and was associated with greater fatigue, symptom burden, and mood disturbance. Sleep quality should be routinely assessed in patients with advanced cancer who are participating in early-phase clinical trials. Cancer 2016;122:3401-3409. © 2016 American Cancer Society.

Factors related to biopsy willingness in patients with advanced cancer in a phase 1 clinic for molecularly targeted therapy.

PURPOSE: Tumor biopsies are critical for delineating pharmacodynamic effects of drugs and for optimal patient selection during oncology clinical trials of molecular targeted therapies. The purpose of this study was to identify factors related to patients' willingness to provide study-related tumor biopsies in phase 1 clinical trials of molecularly targeted therapy. METHODS: An investigator-designed survey, that assessed biopsy willingness, demographic and clinical factors, was completed anonymously by patients with advanced cancer in a phase 1 clinic for targeted therapy. Data were analyzed using multivariate logistic regression models with odds ratios (OR) and 95 % confidence intervals (CI). RESULTS: Three hundred and sixty-two patients with advanced cancer (50 % male, 56 % aged ≤ 60 years) participated. In univariate analyses, willingness to provide study-related biopsy was associated with male gender, white race, higher income, using the Internet for cancer-related information, and having had a biopsy previously (p < 0.05). In multivariate analyses, male gender (OR 2.41, 95 % CI 1.54, 3.78) and having had a biopsy (OR 3.71, 95 % CI 1.68, 8.15) were associated with willingness to have one biopsy; male gender (OR 1.97, 95 % CI 1.30, 3.00) and relying on the Internet as a source of information (OR 1.87, 95 % CI 1.21, 2.89) were associated with willingness to have more than one biopsy. CONCLUSIONS: The results suggest that male gender is associated with greater stated willingness to undergo biopsy. Also, the Internet is an important source of information for patients with cancer and may strongly influence their decisions about whether to consent to biopsies in early clinical trials.