Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer

Ann Langius-Eklöf, Marie-Therése Crafoord, Mats Christiansen, Maria Fjell, Kay Sundberg, Ann Langius-Eklöf, Marie-Therése Crafoord, Mats Christiansen, Maria Fjell, Kay Sundberg

Abstract

Background: Cancer patients are predominantly treated as out-patients and as they often experience difficult symptoms and side effects it is important to facilitate and improve patient-clinician communication to support symptom management and self-care. Although the number of projects within supportive cancer care evaluating mobile health is increasing, few evidence-based interventions are described in the literature and thus there is a need for good quality clinical studies with a randomised design and sufficient power to guide future implementations. An interactive information and communications technology platform, including a smartphone/computer tablet app for reporting symptoms during cancer treatment was created in collaboration with a company specialising in health care management. The aim of this paper is to evaluate the effects of using the platform for patients with breast cancer during neo adjuvant chemotherapy treatment and patients with locally advanced prostate cancer during curative radiotherapy treatment. The main hypothesis is that the use of the platform will improve clinical management, reduce costs, and promote safe and participatory care.

Method: The study is a prospective, randomised, controlled trial for each patient group and it is based on repeated measurements. Patients are consecutively included and randomised. The intervention groups report symptoms via the app daily, during treatment and up to three weeks after end of treatment, as a complement to standard care. Patients in the control groups receive standard care alone. Outcomes targeted are symptom burden, quality of life, health literacy (capacity to understand and communicate health needs and promote healthy behaviours), disease progress and health care costs. Data will be collected before and after treatment by questionnaires, registers, medical records and biomarkers. Lastly, participants will be interviewed about participatory and meaningful care.

Discussion: Results will generate knowledge to enhance understanding about how to develop person-centred care using mobile technology. Supporting patients' involvement in their care to identify problems early, promotes more timely initiation of necessary treatment. This can benefit patients treated outside the hospital setting in regard to maintaining their safety.

Clinical trial registration: June 12 2015 NCT02477137 (Prostate cancer) and June 12 2015 NCT02479607 (Breast cancer).

Keywords: Application; Cancer supportive care; Clinical trial; Cost-effectiveness; Information communications technology; Participatory care; RCT; Study protocol; mHealth.

Conflict of interest statement

Ethical approval and consent to participate

Ethical approval has been obtained from the Regional Ethical Review Board in Stockholm (record number 2013/1652–31/2). All patients to be included in the study will be given oral and written information underscoring the voluntary nature of participation. All participants who agree to participate will sign a written consent form. Logged participant data will be accessible only to researchers in the group and health personnel managing reports and generated alerts when caring for the patient. Only the researchers in the research group will be able to access additional data on participants such as all data collected via questionnaires and in interviews. Data and any other information on participants, collected for, used in or generated by this project will not be used for any other purpose. The results will be presented in such a way that no participant can be identified.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Illustration of the ICT-platform
Fig. 2
Fig. 2
SPIRIT flow chart RCT-study prostate cancer
Fig. 3
Fig. 3
SPIRIT flow chart RCT-study breast cancer

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