Dataset Information

Oral cancer chemotherapy adherence and adherence assessment tools: a report from North Central Cancer Group Trial N0747 and a systematic review of the literature.

ABSTRACT: Oncologists are now prescribing more oral chemotherapy than ever before, thus placing the onus for taking the right dose at the right time under the right circumstances directly on the patient. This study was undertaken to understand emerging adherence issues and to explore available adherence assessment tools. This two-part study (1) examined N0747, a randomized phase II trial that tested the oral agents, sunitinib and capecitabine, in patients with metastatic esophageal cancer from an adherence standpoint, and (2) conducted a systematic review to compile and assess adherence tools that can be used in future clinical trials. First, in N0747, patients were assigned to sunitinib and capecitabine versus capecitabine; 53 chemotherapy cycles were prescribed to this 12-patient cohort. Nearly all patients denoted that they "always or almost always" took their pills as prescribed, and two patients who reported lack of full adherence suffered from grade 3+ adverse events. Surprisingly, however, over 14 cycles, 9 patients reported grade 3+ toxicity but checked "always or almost always" to describe their adherence. No relationships were observed between adherence and cancer outcomes. Secondly, 21 articles identified the following adherence tools: (1) healthcare providers' interviews, (2) patient-reported adherence with diaries/calendars, (3) patient-completed adherence scales, (4) medication event monitoring, (5) automated voice response, (6) drug/metabolite assays, and (7) prescription databases. Of note, only the automated voice response seems capable of real-time detection of over-adherence, as observed in N0747. Oral chemotherapy adherence should be further studied, particularly from the standpoint of over-adherence.

SUBMITTER: Patel K

PROVIDER: S-EPMC3815511 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Oral cancer chemotherapy adherence and adherence assessment tools: a report from North Central Cancer Group Trial N0747 and a systematic review of the literature.

Patel Krishna K Foster Nathan R NR Farrell Ann A Le-Lindqwister Nguyet Anh NA Mathew Josy J Costello Brian B Reynolds John J Meyers Jeffrey P JP Jatoi Aminah A

Journal of cancer education : the official journal of the American Association for Cancer Education 20131201 4

Oncologists are now prescribing more oral chemotherapy than ever before, thus placing the onus for taking the right dose at the right time under the right circumstances directly on the patient. This study was undertaken to understand emerging adherence issues and to explore available adherence assessment tools. This two-part study (1) examined N0747, a randomized phase II trial that tested the oral agents, sunitinib and capecitabine, in patients with metastatic esophageal cancer from an adherenc ...[more]

PMID: 23872949

Similar Datasets

Project description:BACKGROUND:Adherence to oral chemotherapy is crucial to maximize treatment outcomes and avoid health complications in cancer patients. Mobile phones are widely available worldwide, and evidence that this technology can be successfully employed to increase medication adherence for the treatment of other chronic diseases (eg, diabetes) is well established. However, the extent to which there is evidence that mobile phone-based interventions improve adherence to oral chemotherapy is unknown. OBJECTIVE:This scoping review aims to explore what is known about mobile phone-delivered interventions designed to enhance adherence to oral chemotherapy, to examine the reported findings on the utility of these interventions in increasing oral chemotherapy adherence, and to identify opportunities for development of future interventions. METHODS:This study followed Arksey and O'Malley's scoping review methodological framework. RESULTS:The review search yielded 5 studies reporting on 4 interventions with adults (aged >18 years) diagnosed with diverse cancer types. All interventions were considered acceptable, useful, and feasible. The following themes were evident: text messages and mobile apps were the main methods of delivering these interventions, the 2 most commonly employed oral chemotherapy adherence-enhancing strategies were management and reporting of drug-related symptoms and reminders to take medication, the importance of stakeholders' engagement in intervention design, and the overall positive perceptions of delivery features. Areas for future research identified by this review include the need for further studies to evaluate the impact of mobile phone-delivered interventions on adherence to oral chemotherapy as well as the relevance for future studies to incorporate design frameworks and economic evaluations and to explore the moderator effect of high anxiety, poor baseline adherence, and longer time taking prescribed drug on adherence to oral chemotherapy. CONCLUSIONS:Despite the increasing body of evidence on the use of mobile phones to deliver medication adherence-enhancing interventions in chronic diseases, literature on the oral chemotherapy context is lacking. This review showed that existing interventions are highly acceptable and useful to cancer patients. The engagement of stakeholders as well as the use of a design framework are important elements in the development of mobile phone-delivered interventions that can be translated into oncology settings.

Project description:The interest in using physiologically-based pharmacokinetic (PBPK) models as a support to the drug development decision making process has rapidly increased in the last years. These kind of models are examples of the "bottom up" modelling strategy, which progressively integrates into a mechanistic framework different information as soon as they become available along the drug development. For this reason PBPK models can be used with different aims, from the early stages of drug development up to the clinical phases. Different software tools are nowadays available. They can be categorized in "designed software" and "open software". The first ones typically include commercial platforms expressly designed to implement PBPK models, in which the model structure is pre-defined, assumptions are generally not explicitly declared and equations are hidden to the user. Even if the software is validated and routinely used in the pharmaceutical industry, sometimes they do not allow working with the flexibility needed to cope with specific applications/tasks. For this reason, some scientists prefer to define and implement their own PBPK tool in "open" software. This paper shows how to build an in-house PBPK tool from species-related physiological information available in the literature and a limited number of drug specific parameters generally made available by the drug development process. It also reports the results of an evaluation exercise that compares simulated plasma concentration-time profiles and related pharmacokinetic (PK) parameters (i.e., AUC, Cmax and Tmax) with literature and in-house data. This evaluation involved 25 drugs with different physico-chemical properties, intravenously or orally administrated in three different species (i.e., rat, dog and man). The comparison shows that model predictions have a good degree of accuracy, since the average fold error for all the considered PK parameters is close to 1 and only in few cases the fold error is greater than 2. In summary, the paper demonstrates that addressing specific aims when needed is possible by creation of in-house PBPK tools with satisfactory performances and it provides some suggestions how to do that.

Project description:IntroductionOral, vaginal and other pre-exposure prophylaxis (PrEP) products for HIV prevention are in various stages of development. Low adherence poses a serious challenge to successful evaluation in trials. In a previous study, we developed tools to screen for general adherence and specifically monitor intravaginal ring adherence within the context of HIV prevention clinical trials. This study aimed to further validate the screening tool and to adapt and provide initial psychometric validation for an oral pill monitoring tool.Materials and methodsWe administered a cross-sectional survey between June and October 2018 at a trial site located near Cape Town, South Africa, and another in Thika, Kenya, with 193 women who had experience using daily oral pills. We fit confirmatory factor analysis models on the screening tool items to assess our previously-hypothesized subscale structure. We conducted an exploratory factor analysis of oral PrEP monitoring items to determine the underlying subscale structure. We then assessed the construct validity of each tool by comparing subscales against each other within the current sample and against our original sample, from a study conducted in four sites in South Africa, including Cape Town.ResultsThe screening tool structure showed moderate evidence of construct validity. As a whole, the tool performed in a similar way to the original sample. The monitoring tool items, which were revised to assess perceptions about and experiences using daily oral PrEP, factored into five subscales that showed moderate to good reliability. Four of the five subscales had a similar structure overall to the vaginal ring monitoring tool from which they were adapted.ConclusionsAccurate measurement of HIV-prevention product adherence is of critical importance to the assessment of product efficacy and safety in clinical trials, and the support of safe and effective product use in non-trial settings. In this study, we provide further validation for these measures, demonstrating the screening tool's utility in additional populations and adapting the monitoring tool's utility for different HIV-prevention products.

Dataset Information

Oral cancer chemotherapy adherence and adherence assessment tools: a report from North Central Cancer Group Trial N0747 and a systematic review of the literature.

Publications

Oral cancer chemotherapy adherence and adherence assessment tools: a report from North Central Cancer Group Trial N0747 and a systematic review of the literature.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets