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      Mobile Health Intervention to Increase Oral Cancer Therapy Adherence in Patients With Chronic Myeloid Leukemia (The REMIND System): Clinical Feasibility and Acceptability Assessment

      research-article
      , BNurs, MPH, MHealthEc 1 , 2 , , DipEd, BSc (Hons) 3 , , BSc (Biochem), MSc (Biochem), PGDip (Epi) 4 , , BA (Hons), PhD 4 , , RN 5 , , MBBS, PhD 6 , 7 , , BA (Hons), DipEd, MClinPsych, MPH, PhD 8 , , BSc (Hons), MSc, PhD 9 , , BCompSc (Hons) 9 , , RN, BAppSci, MN, PhD, GAICD 3 , 10 , , BSc (Hons), PhD 3 , 11 , , BPharm, GradDipHospPharm, FSHP 12 , 13 , , BBus, CPA 3 , , BSc (Hons), PhD 3 , 7 , 14 ,
      (Reviewer), (Reviewer)
      JMIR mHealth and uHealth
      JMIR Publications
      mobile phone, neoplasms, Internet, medication adherence

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          Abstract

          Background

          Optimal dosing of oral tyrosine kinase inhibitor therapy is critical to treatment success and survival of patients with chronic myeloid leukemia (CML). Drug intolerance secondary to toxicities and nonadherence are significant factors in treatment failure.

          Objective

          The objective of this study was to develop and pilot-test the clinical feasibility and acceptability of a mobile health system (REMIND) to increase oral drug adherence and patient symptom self-management among people with CML (chronic phase).

          Methods

          A multifaceted intervention was iteratively developed using the intervention development framework by Schofield and Chambers, consisting of defining the patient problem and iteratively refining the intervention. The clinical feasibility and acceptability were examined via patient and intervention nurse interviews, which were audiotaped, transcribed, and deductively content analyzed.

          Results

          The intervention comprised 2 synergistically operating elements: (1) daily medication reminders and routine assessment of side effects with evidence-based self-care advice delivered in real time and (2) question prompt list (QPL) questions and routinely collected individual patient adherence and side effect profile data used to shape nurses’ consultations, which employed motivational interviewing to support adoption of self-management behaviors. A total of 4 consultations and daily alerts and advice were delivered over 10 weeks. In total, 58% (10/17) of patients and 2 nurses participated in the pilot study. Patients reported several benefits of the intervention: help in establishing medication routines, resolution of symptom uncertainty, increased awareness of self-care, and informed decision making. Nurses also endorsed the intervention: it assisted in establishing pill-taking routines and patients developing effective solutions to adherence challenges.

          Conclusions

          The REMIND system with nurse support was usable and acceptable to both patients and nurses. It has the potential to improve adherence and side-effect management and should be further evaluated.

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          Most cited references50

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          Intrinsic Motivation and Self-Determination in Human Behavior

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            Development and testing of a short form of the patient activation measure.

            The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. The measure was developed using Rasch analyses and is an interval level, unidimensional, Guttman-like measure. The current analysis is aimed at reducing the number of items in the measure while maintaining adequate precision. We relied on an iterative use of Rasch analysis to identify items that could be eliminated without loss of significant precision and reliability. With each item deletion, the item scale locations were recalibrated and the person reliability evaluated to check if and how much of a decline in precision of measurement resulted from the deletion of the item. The data used in the analysis were the same data used in the development of the original 22-item measure. These data were collected in 2003 via a telephone survey of 1,515 randomly selected adults. Principal Findings. The analysis yielded a 13-item measure that has psychometric properties similar to the original 22-item version. The scores for the 13-item measure range in value from 38.6 to 53.0 (on a theoretical 0-100 point scale). The range of values is essentially unchanged from the original 22-item version. Subgroup analysis suggests that there is a slight loss of precision with some subgroups. The results of the analysis indicate that the shortened 13-item version is both reliable and valid.
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              Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial.

              Imatinib treatment significantly improves survival in patients with chronic myeloid leukaemia (CML), but little is known about whether treatment can safely be discontinued in the long term. We aimed to assess whether imatinib can be discontinued without occurrence of molecular relapse in patients in complete molecular remission (CMR) while on imatinib. In our prospective, multicentre, non-randomised Stop Imatinib (STIM) study, imatinib treatment (of >2 years duration) was discontinued in patients with CML who were aged 18 years and older and in CMR (>5-log reduction in BCR-ABL and ABL levels and undetectable transcripts on quantitative RT-PCR). Patients who had undergone immunomodulatory treatment (apart from interferon α), treatment for other malignancies, or allogeneic haemopoietic stem-cell transplantation were not included. Patients were enrolled at 19 participating institutions in France. In this interim analysis, rate of relapse was assessed by use of RT-PCR for patients with at least 12 months of follow-up. Imatinib was reintroduced in patients who had molecular relapse. This study is registered with ClinicalTrials.gov, number NCT00478985. 100 patients were enrolled between July 9, 2007, and Dec 17, 2009. Median follow-up was 17 months (range 1-30), and 69 patients had at least 12 months follow-up (median 24 months, range 13-30). 42 (61%) of these 69 patients relapsed (40 before 6 months, one patient at month 7, and one at month 19). At 12 months, the probability of persistent CMR for these 69 patients was 41% (95% CI 29-52). All patients who relapsed responded to reintroduction of imatinib: 16 of the 42 patients who relapsed showed decreases in their BCR-ABL levels, and 26 achieved CMR that was sustained after imatinib rechallenge. Imatinib can be safely discontinued in patients with a CMR of at least 2 years duration. Imatinib discontinuation in this setting yields promising results for molecular relapse-free survival, raising the possibility that, at least in some patients, CML might be cured with tyrosine kinase inhibitors. Copyright © 2010 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                Journal
                JMIR Mhealth Uhealth
                JMIR Mhealth Uhealth
                JMU
                JMIR mHealth and uHealth
                JMIR Publications (Toronto, Canada )
                2291-5222
                December 2017
                06 December 2017
                : 5
                : 12
                : e184
                Affiliations
                [01] 1 Centre for Nursing Research Cabrini Institute Malvern, Victoria Australia
                [02] 2 Faculty of Medicine, Nursing and Health Sciences Monash University Clayton, Victoria Australia
                [03] 3 Department of Cancer Experiences Research Peter MacCallum Cancer Centre East Melbourne, Victoria Australia
                [04] 4 School of Nursing and Midwifery Faculty of Health Deakin University Geelong, Victoria Australia
                [05] 5 Department of Haematology Royal Adelaide Hospital Adelaide, South Australia Australia
                [06] 6 Department of Haematology Peter MacCallum Cancer Centre East Melbourne, Victoria Australia
                [07] 7 Sir Peter MacCallum Department of Oncology Faculty of Medicine, Dentistry and Health Sciences The University of Melbourne Parkville, Victoria Australia
                [08] 8 School of Psychology The University of Sydney Sydney, New South Wales Australia
                [09] 9 School of Science RMIT University Melbourne, Victoria Australia
                [10] 10 Cancer Council Australia Sydney, New South Wales Australia
                [11] 11 Public Health Group, Stroke Division The Florey Institute of Neuroscience and Mental Health Heidelberg , Victoria Australia
                [12] 12 Pharmacy Department Monash Health Clayton, Victoria Australia
                [13] 13 Faculty of Pharmacy and Pharmaceutical Sciences Monash University Parkville, Victoria Australia
                [14] 14 Department of Psychology School of Health Sciences, Faculty of Health, Arts and Design Swinburne University of Technology Hawthorn, Victoria Australia
                Author notes
                Corresponding Author: Penelope Schofield pschofield@ 123456swin.edu.au
                Author information
                http://orcid.org/0000-0002-8353-8230
                http://orcid.org/0000-0003-2957-5767
                http://orcid.org/0000-0002-3806-0020
                http://orcid.org/0000-0002-2473-8435
                http://orcid.org/0000-0002-2985-7791
                http://orcid.org/0000-0003-2188-6835
                http://orcid.org/0000-0003-3562-6954
                http://orcid.org/0000-0001-7464-857X
                http://orcid.org/0000-0003-0034-8368
                http://orcid.org/0000-0003-4170-9799
                http://orcid.org/0000-0001-9896-004X
                http://orcid.org/0000-0002-4029-3288
                http://orcid.org/0000-0002-1476-201X
                http://orcid.org/0000-0001-9495-9543
                Article
                v5i12e184
                10.2196/mhealth.8349
                5738545
                29212628
                51796ebe-defb-4075-a5bd-997d31f57b85
                ©Amanda Pereira-Salgado, Jennifer A Westwood, Lahiru Russell, Anna Ugalde, Bronwen Ortlepp, John F Seymour, Phyllis Butow, Lawrence Cavedon, Kevin Ong, Sanchia Aranda, Sibilah Breen, Suzanne Kirsa, Andrew Dunlevie, Penelope Schofield. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 06.12.2017.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mhealth and uhealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included.

                History
                : 5 July 2017
                : 27 September 2017
                : 4 October 2017
                Categories
                Original Paper
                Original Paper

                mobile phone,neoplasms,internet,medication adherence
                mobile phone, neoplasms, internet, medication adherence

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