Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT)

Abstract

Background: There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management. Methods: This randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3, 6, and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilization data from Discover, an integrated care record of primary, secondary, and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per-protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results. Discussion: This study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination. Trial registration: The study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.

Mobile Applications Available in Germany Supporting Breast Cancer Patients During Treatment and Aftercare: a Systematic Review

“…The questions are explained very well in simple language. The efficacy of OWise is in improving patient motivation and activity in women with early-stage breast cancer, and was published in the BMC Trials in January 2020 2323 . The user data protection policy was in accordance with the latest EU data protection regulations.…”

Evaluating Barriers and Facilitators to the Uptake of mHealth Apps in Cancer Care Using the Consolidated Framework for Implementation Research: Scoping Literature Review

“…Of the 91 studies, 78 (86%) [8,9,12,16, were research articles, whereas 13 (14%) [119][120][121][122][123][124][125][126][127][128][129][130][131] Owing to their heterogeneous nature, the selected articles had different study durations, ranging from 2 weeks for small-scale trials to up to 2 years for larger-scale RCTs. The median sample size of the study participants was 51, ranging from a minimum of 5 to a maximum of 4475 patients.…”

“…The selected studies assessed mHealth impact using a wide range of outcome metrics analyzed using the taxonomy by Dodd et al [42]. Outcomes most recurrently fall under the Life impact area, with 73 outcomes in the Delivery of Care outcome domain [8,9,12,16,45,46,48- [66,69,84,115,125,126,131]. Within this core area, recurring metrics were the acceptability, usability, and feasibility of mHealth apps, which could be assessed either using validated questionnaires, or qualitatively, through study-specific questionnaires or interviews.…”

“…55,57-63,65,67,70,71,73-87,90-92, 94-104,107-116,119-122,128-131], 37 in Global quality of life[8,57,60,62,64,65,68,72,75,78,84,86,[88][89][90][91]93,97,101,103,105,106,112,114,115,[119][120][121][123][124][125][126][127][128][129][130][131], 16 in Emotional functioning and well-being[66,70,77,83,89,90,93,106,115,119,[125][126][127][128]…”

Measuring Clinical, Biological, and Behavioral Variables to Elucidate Trajectories of Patient-Reported Outcomes: The PROFILES Registry

“…Currently, the PROFILES approach is being copied in other countries where the PROFILES team advises colleagues about setting up and implementing similar infrastructures. The Royal Marsden Cancer Hospital in London has been using PROFILES since 2019, which stimulates collaboration in the study of rare cancers and enables comparison between the English and Dutch cancer care ( 84 , 85 ).…”