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
Open accessAbstract
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).
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Researchers evaluated a range of measures that aligned with their target chronic condition, such as blood glucose, weight, symptoms, patient-reported outcomes, diary entries, and steps.
“Researchers evaluated a range of measures that aligned with their target chronic condition, such as blood glucose [56,60,61,64,73], weight [56,73,74], symptoms [66,68,69], patient-reported outcomes [38,46,52,65,71], diary entries [47,66], and steps [51].”
From A Library of Analytic Indicators to Evaluate Effective Engagement with Consumer mHealth Apps for Chronic Conditions: Scoping Review (2019) · cites this paper as [69]
Reviewed studies assessed the number of videos watched from a playlist, educational modules completed, or self-care advice accessed.
“Others assessed the number of videos watched from a playlist [36,55], educational modules completed [52], or self-care advice accessed [69].”
From A Library of Analytic Indicators to Evaluate Effective Engagement with Consumer mHealth Apps for Chronic Conditions: Scoping Review (2019) · cites this paper as [69]
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Pham, Q., Graham, G., Carrion, C., Morita, P. P., Seto, E., Stinson, J. N., & Cafazzo, J. A. (2019) · JMIR mHealth and uHealth · doi:10.2196/11941 · Cited by 131 · see citing works
- Authors
- Langius-Eklöf, A., Crafoord, M.-T., Christiansen, M., Fjell, M., & Sundberg, K.
- Affiliations
- Karolinska Institutet (SE)
- Venue
- BMC Cancer
- Published
- 2017-07-04
- Volume
- 17
- Issue
- 1
- Pages
- 466-466
- ISSN
- 1471-2407 (ISSN-L)
- PMC
- PMC5496395
- OpenAlex
- W2732199202
- Cited by
- 51
- References
- 72
- Citations by year
- 2026: 5 · 2025: 5 · 2024: 5 · 2023: 6 · 2022: 9 · 2021: 1 · 2020: 10 · 2019: 5 · 2018: 5
- FWCI
- 8.83
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- BMC Cancer (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DiVA (University of Gävle) (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Familjen Kamprads stiftelse (20150015)
- Vetenskapsrådet (521-2014-2723)
- Forskningsrådet om Hälsa, Arbetsliv och Välfärd (2014-4713)
- Cancerfonden (140711)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Keywords
- mobile health, symptom distress, early detection, participatory care, person-centred care, breast cancer, prostate cancer, neoadjuvant chemotherapy, radiotherapy, patient-clinician communication, health literacy, quality of life, health care costs, cancer supportive care, self-care
- MeSH terms
- Patient Reported Outcome Measures, Breast Neoplasms, Clinical Protocols, Female, Humans, Male, Prostatic Neoplasms, Outcome Assessment, Health Care, Telemedicine, Early Detection of Cancer, Workflow, Health Communication, Standard of Care
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