Patient satisfaction while enrolled in clinical trials: A literature review

Patient satisfaction surveys may not adequately reflect organizations that conduct research in patients who enroll in clinical trials. The purpose of this systematic literature review was to summarize the current state of knowledge of patient satisfaction while enrolled in clinical trials utilizing a widely used, validated patient satisfaction instrument. A comprehensive literature search was conducted using CINAHL, EMBASE, PsycInfo, PubMed and Web of Science. Studies were evaluated in terms of clinical trial participation; assessment conducted during or after participation; utilization of a validated instrument; a pharmacological intervention; and the paper was published in English. Only nine studies met this review’s inclusion criteria. Eight studies utilized investigator-developed patient satisfaction instruments and only one study used a widely-used, validated patient satisfaction instrument. Two studies evaluated patient satisfaction during the development of the instrument. Of the nine studies identified, only five patient satisfaction domains were common across the studies and only study evaluated the associations of patient satisfaction responses with clinical outcomes. Given the importance of patient satisfaction surveys, future studies need to focus on this subset of patients enrolled in clinical trials to evaluate a patient’s experience and its impact on protocol compliance and protocol outcomes. Future studies need to focus on domains associated with clinical trial participation and look beyond the current patients’ general expectations about healthcare accessibility, facilities, healthcare team clinical skills, and their ability to focus and listen to the patients’ concerns. Experience Framework This article is associated with the Policy & Measurement lens of The Beryl Institute Experience Framework. (https://www.theberylinstitute.org/ExperienceFramework). Access other PXJ articles related to this lens. Access other resources related to this lens

Designing a broad-spectrum integrative approach for cancer prevention and treatment.

Targeted therapies and the consequent adoption of "personalized" oncology have achieved notable successes in some cancers; however, significant problems remain with this approach. Many targeted therapies are highly toxic, costs are extremely high, and most patients experience relapse after a few disease-free months. Relapses arise from genetic heterogeneity in tumors, which harbor therapy-resistant immortalized cells that have adopted alternate and compensatory pathways (i.e., pathways that are not reliant upon the same mechanisms as those which have been targeted). To address these limitations, an international task force of 180 scientists was assembled to explore the concept of a low-toxicity "broad-spectrum" therapeutic approach that could simultaneously target many key pathways and mechanisms. Using cancer hallmark phenotypes and the tumor microenvironment to account for the various aspects of relevant cancer biology, interdisciplinary teams reviewed each hallmark area and nominated a wide range of high-priority targets (74 in total) that could be modified to improve patient outcomes. For these targets, corresponding low-toxicity therapeutic approaches were then suggested, many of which were phytochemicals. Proposed actions on each target and all of the approaches were further reviewed for known effects on other hallmark areas and the tumor microenvironment. Potential contrary or procarcinogenic effects were found for 3.9% of the relationships between targets and hallmarks, and mixed evidence of complementary and contrary relationships was found for 7.1%. Approximately 67% of the relationships revealed potentially complementary effects, and the remainder had no known relationship. Among the approaches, 1.1% had contrary, 2.8% had mixed and 62.1% had complementary relationships. These results suggest that a broad-spectrum approach should be feasible from a safety standpoint. This novel approach has potential to be relatively inexpensive, it should help us address stages and types of cancer that lack conventional treatment, and it may reduce relapse risks. A proposed agenda for future research is offered.Multiple funders. See acknowledgments within article for details.This is the final version of the article. It first appeared from Elsevier via http://dx.doi.org/10.1016/j.semcancer.2015.09.00