A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial

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Abstract

Background

The well-being of breast cancer patients and reporting of adverse events require close monitoring. Mobile apps allow continuous recording of disease- and medication-related symptoms in patients undergoing chemotherapy.

Objective

The aim of the study was to evaluate the effects of a mobile app on patient-reported daily functional activity in a supervised and unsupervised setting.

Methods

We conducted a randomized controlled study of 139 breast cancer patients undergoing chemotherapy. Patient status was self-measured using Eastern Cooperative Oncology Group scoring and Common Terminology Criteria for Adverse Events. Participants were randomly assigned to a control group, an unsupervised group that used a mobile app to record data, or a supervised group that used the app and reviewed data with a physician. Primary outcome variables were change in daily functional activity and symptoms over three outpatient visits.

Results

Functional activity scores declined in all groups from the first to second visit. However, from the second to third visit, only the supervised group improved, whereas the others continued to decline. Overall, the supervised group showed no significant difference from the first (median 90.85, IQR 30.67) to third visit (median 84.76, IQR 18.29, P=.72). Both app-using groups reported more distinct adverse events in the app than in the questionnaire (supervised: n=1033 vs n=656; unsupervised: n=852 vs n=823), although the unsupervised group reported more symptoms overall (n=4808) in the app than the supervised group (n=4463).

Conclusions

The mobile app was associated with stabilized daily functional activity when used under collaborative review. App-using participants could more frequently report adverse events, and those under supervision made fewer and more precise entries than unsupervised participants. Our findings suggest that patient well-being and awareness of chemotherapy adverse effects can be improved by using a mobile app in collaboration with the treating physician.

ClinicalTrial

ClinicalTrials.gov NCT02004496; https://clinicaltrials.gov/ct2/show/NCT02004496 (Archived by WebCite at http://www.webcitation.org/6k68FZHo2)

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Most cited references 6

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The Patient Remote Intervention and Symptom Management System (PRISMS) – a Telehealth- mediated intervention enabling real-time monitoring of chemotherapy side-effects in patients with haematological malignancies: study protocol for a randomised controlled trial

Sibilah Breen, David Ritchie, Penelope Schofield … (2015)

Background Outpatient chemotherapy is a core treatment for haematological malignancies; however, its toxicities frequently lead to distressing/potentially life-threatening side-effects (neutropenia/infection, nausea/vomiting, mucositis, constipation/diarrhoea, fatigue). Early detection/management of side-effects is vital to improve patient outcomes, decrease morbidity and limit lengthy/costly hospital admissions. The ability to capture patient-reported health data in real-time, is regarded as the ‘gold-standard’ to allow rapid clinical decision-making/intervention. This paper presents the protocol for a Phase 3 multi-site randomised controlled trial evaluating a novel nurse-led Telehealth intervention for remote monitoring/management of chemotherapy side-effects in Australian haematological cancer patients. Methods/Design Two hundred and twenty-two patients will be recruited from two hospitals. Eligibility criteria include: diagnosis of chronic lymphocytic leukaemia/Hodgkin’s/non-Hodgkin’s lymphoma; aged ≥ 18 years; receiving ≥ 2 cycles chemotherapy. Patients will be randomised 1:1 to either the control or intervention arm with stratification by diagnosis, chemotherapy toxicity (high versus low), receipt of previous chemotherapy and hospital. Patients allocated to the control arm will receive ‘Usual Care’ whilst those allocated to the intervention will receive the intervention in addition to ‘Usual Care’. Intervention patients will be provided with a computer tablet and software prompting twice-daily completion of physical/emotional scales for up to four chemotherapy cycles. Should patient data exceed pre-determined limits an Email alert is delivered to the treatment team, prompting nurses to view patient data, and contact the patient to provide clinical intervention. In addition, six scheduled nursing interventions will be completed to educate/support patients in use of the software. Patient outcomes will be measured cyclically (midpoint and end of cycles) via pen-and-paper self-report alongside review of the patient medical record. The primary outcome is burden due to nausea, mucositis, constipation and fatigue. Secondary outcomes include: burden due to vomiting and diarrhoea; psychological distress; ability to self-manage health; level of cancer information/support needs and; utilisation of health services. Analyses will be intention-to-treat. A cost-effectiveness analysis is planned. Discussion This trial is the first in the world to test a remote monitoring/management intervention for adult haematological cancer patients receiving chemotherapy. Future use of such interventions have the potential to improve patient outcomes/safety and decrease health care costs by enabling early detection/clinical intervention. Trial registration ACTRN12614000516684. Date registered: 12 March 2014 (registered retrospectively).

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A Telemedicine-Based Intervention Reduces the Frequency and Severity of COPD Exacerbation Symptoms: A Randomized, Controlled Trial

Francis Cordova, David Ciccolella, Carla L Grabianowski … (2015)

Background: Patients with chronic obstructive pulmonary disease (COPD) may not recognize worsening symptoms that require intensification of therapy. They may also be reluctant to contact a healthcare provider for minor worsening of symptoms. A telemedicine application for daily symptom reporting may reduce these barriers and improve patient outcomes. Materials and Methods: Patients hospitalized for a COPD exacerbation within the past year or using supplemental O 2 were approached for participation. Patients received optimal COPD care and were given a telecommunication device for symptom reporting. Initial symptom scores were obtained while patients were in their usual state of health. Patients were randomly assigned to an intervention group or a control group (usual medical care). The control group patients were instructed to seek medical care if their condition worsened. The intervention group symptom scores were assessed by a computer algorithm and compared with initial values. Scores 1 or more points above the initial score generated an “alert,” and patients were reviewed by a nurse and referred to a physician who prescribed treatment. Results: Eighty-six patients were screened; 79 met entry criteria and were randomized (intervention group, n =39; control group, n =40). Twelve patients submitted five or fewer symptom reports (5 intervention; 7 control) and were excluded from the analysis. Daily peak flow and dyspnea scores improved only in the intervention group. There were no differences in hospitalization and mortality rates between groups. No serious adverse events were reported. Conclusions: A telemedicine-based symptom reporting program facilitated early treatment of symptoms and improved lung function and functional status.

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Blowing in the Wind: Unanchored Patient Information Work during Cancer Care.

Predrag Klasnja, Andrea Hartzler, Kent T Unruh … (2010)

Patients do considerable information work. Technologies that help patients manage health information so they can play active roles in their health-care, such as personal health records, provide patients with effective support for focused and sustained personal health tasks. Yet, little attention has been paid to patients' needs for information management support while on the go and away from their personal health information collections. Through a qualitative field study, we investigated the information work that breast cancer patients do in such 'unanchored settings'. We report on the types of unanchored information work that patients do over the course of cancer treatment, reasons this work is challenging, and strategies used by patients to overcome those challenges. Our description of unanchored patient information work expands our understanding of patients' information practices and points to valuable design directions for supporting critical but unmet needs.

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Author and article information

Contributors

Andreas Trojan:

Breast-Center ZurichHardturmstrasse 135Zurich, 8005Switzerland41 43 344 33 3341 43 344 33 44andreas.trojan@ozh.ch

ORCID: http://orcid.org/0000-0001-7257-9312

Journal

Journal ID (nlm-ta): J Med Internet Res

Journal ID (iso-abbrev): J. Med. Internet Res

Journal ID (publisher-id): JMIR

Title: Journal of Medical Internet Research

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Print): 1439-4456

ISSN (Electronic): 1438-8871

Publication date Collection: September 2016

Publication date (Electronic): 06 September 2016

Volume: 18

Issue: 9

Electronic Location Identifier: e238

Affiliations

[1] ¹Department of Clinical Pharmacology and Toxicology University Hospital Zurich and University of Zurich ZurichSwitzerland

[2] ²EBPI Department of Biostatistics University of Zurich ZurichSwitzerland

[3] ³Department of Orthopedics and Emergency Department Waid City Hospital ZurichSwitzerland

[4] ⁴Advocacy AG ZurichSwitzerland

[5] ⁵Breast-Center Zurich ZurichSwitzerland

Author notes

Corresponding Author: Andreas Trojan andreas.trojan@ 123456ozh.ch

Author information

Marco Egbring http://orcid.org/0000-0002-4201-1483

Elmira Far http://orcid.org/0000-0002-7339-9329

Malgorzata Roos http://orcid.org/0000-0001-6636-098X

Michael Dietrich http://orcid.org/0000-0003-2512-3368

Mathis Brauchbar http://orcid.org/0000-0001-8686-6304

Gerd A Kullak-Ublick http://orcid.org/0000-0002-0757-4408

Andreas Trojan http://orcid.org/0000-0001-7257-9312

Article

Publisher ID: v18i9e238

DOI: 10.2196/jmir.6414

PMC ID: 5030453

PubMed ID: 27601354

SO-VID: 62265476-74d0-422a-9e75-3dadb2d2adb3

Copyright © ©Marco Egbring, Elmira Far, Malgorzata Roos, Michael Dietrich, Mathis Brauchbar, Gerd A Kullak-Ublick, Andreas Trojan. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.09.2016.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

History

Date received : 26 July 2016

Date revision requested : 11 August 2016

Date revision received : 18 August 2016

Date accepted : 21 August 2016

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