REBECCA – D1.2: REBECCA co-creation methodology and plan

This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 965231. Horizon 2020 EUROPEAN COMMISSION Directorate-General for Research and Innovation People, Combating Diseases D1.2 – REBECCA co-creation methodology and plan Project Acronym: REBECCA Grant Agreement No: 965231 Project Full Title: Research on breast cancer induced chronic conditions supported by causal analysis of multi-source data Starting Date: 1/4/ 2021 Duration in Months: 54 H2020SC1-DTH-12-2020 D1.2 2 | 51 Deliverable version 2.0 Date 11 February 2025 Nature of deliverable Report Dissemination level Public Work Package WP1 – User requirements and co-creation Lead Beneficiary KI Author(s) / Contributor(s) Alkyoni Glympi (KI), Ioannis Ioakeimidis (KI) Status Submitted H2020SC1-DTH-12-2020 D1.2 3 | 51 Document History Version1 Issue Date Status2 Content and Changes 0.1 20 December 2021 Draft Initial draft describing methodology and planning 1.0 20 January 2024 Final Complete version with evaluation framework and planning at M9 (Sections 2 and 3) 2.0 11 February 2024 Final Second complete version, reporting on updates and adjustments in the planning at M39 (Section 4) 1 Please use a new number for each new version of the deliverable. Use “0.#” for Draft and PeerReviewed. “x.#” for Submitted and Approved”, where x>=1.Add the date when this version was issued and list the items that have been added or changed. 2 A deliverable can be in one of these stages: Draft, Peer-Reviewed, Submitted and Approved. H2020SC1-DTH-12-2020 D1.2 4 | 51 Table of Contents Document History ..................................................................................................................... 3 Abbreviations and Acronyms ................................................................................................ 5 Executive Summary ................................................................................................................... 6 1 Introduction ......................................................................................................................... 8 1.1 Intended audience and reading suggestions ................................................................................. 8 1.2 Methodology ............................................................................................................................................... 8 1.3 Organization of the document ............................................................................................................. 8 2 Evaluation framework .................................................................................................... 10 2.1 Technology Acceptance Model .......................................................................................................... 10 2.2 The System Usability Scale ................................................................................................................... 12 2.3 The User Experience Questionnaire .................................................................................................. 13 3 Co-creation activities ..................................................................................................... 15 3.1 System co-creation through BCP focus groups ........................................................................... 15 3.2 Focused discussions and workshops with medical experts ..................................................... 16 3.3 Large-scale questionnaire survey ...................................................................................................... 17 3.4 Co-creation meetings to develop behavioural indicators ....................................................... 18 3.5 Preliminary use of the system – Pilot testing ................................................................................ 18 3.6 Development of individualized consultation protocol and reporting scheme ................ 19 3.7 Continuous co-creation and user feedback integration ........................................................... 19 3.8 Validation of the system ........................................................................................................................ 20 4 Updates and additions to co-creation activities at M39 .................................. 21 4.1 Overview of co-creation activities ..................................................................................................... 21 4.2 Companion App co-creation ............................................................................................................... 22 4.3 Norwegian Cancer Society meeting ................................................................................................. 22 4.4 Validation study ........................................................................................................................................ 22 4.5 Positive reporting categories into the pApp ................................................................................. 23 4.6 Feasibility study ........................................................................................................................................ 24 5 Conclusions ....................................................................................................................... 26 A. Annex A: Focus groups ................................................................................................. 27 B. ANNEX B: Large scale survey ...................................................................................... 29 C. ANNEX C: Validation study protocol ....................................................................... 51 H2020SC1-DTH-12-2020 D1.2 5 | 51 Abbreviations and Acronyms BCP Breast Cancer Patients BCS Breast Cancer Survivors cApp Companion app CDC Centers for Disease Control and Prevention CRF Case Report Form ECFR Electronic Case File Repository EHR Electronic Health Record mHealth mobile Health pApp Patient app PoI Point of Interest QoL Quality of Life REDCap Research Electronic Data Capture SUS System Usability Scale TAM Technology Acceptance Model UEQ User Experience Questionnaire WCRF World Cancer Research Fund WHO World Health Organization H2020SC1-DTH-12-2020 D1.2 6 | 51 Executive Summary Executive summary (updated, for version 2.0) This document is the updated version of deliverable D1.2 at M39, incorporating new activities that were not included in the initial planning. These updates are highlighted in the newly added Section 4. While both the validation of the REBECCA system and the cApp co-creation were initially planned, their specific methodologies had not been determined. The cApp cocreation followed an iterative process, integrating feedback from clinical experts before being refined through workshops with Amazona members, KI, and AUTH. Similarly, in June 2023, a validation study was conducted to assess the functionality and accuracy of the GPS in identifying Points of Interest (PoIs), ensure proper data collection through the app and wearable devices, and refine the process based on participant feedback before the intervention studies. In addition to these planned but undefined in methodology activities, three additional co-creation initiatives were introduced: a meeting with the Norwegian Cancer Society, the integration of positive event reporting categories into the pApp, and the feasibility study. The Norwegian Cancer Society organized a meeting with 30 of its members to discuss the ongoing REBECCA study at SUH. The addition of positive event reporting in the pApp was a patient-driven initiative, with KI leading an internal process that culminated in focused discussions with Amazonas to finalize the annotation options. Lastly, the feasibility study has recently begun, incorporating new features and app updates to evaluate BCS acceptance, engagement, and usage of the REBECCA system in real-world settings. A secondary aim is to assess potential improvements in QoL through personalized lifestyle consultations. The results of these activities will be documented in D1.4. Executive summary (original, for version 1.0) This document outlines the co-creation methodology, plan, and processes for the REBECCA project, designed to foster meaningful collaboration among patients, healthcare professionals, technical teams, and stakeholders. The methodology ensures the development of a user-centred platform, underpinned by a flexible evaluation framework that will evolve throughout the project lifecycle. The document serves as a live resource, with updates planned for milestones M9 (v1.0) and M39 (v2.0). H2020SC1-DTH-12-2020 D1.2 7 | 51 The evaluation framework integrates three core components: an adapted version of the Technology Acceptance Model (TAM), the System Usability Scale (SUS), and the User Experience Questionnaire (UEQ). The TAM adaptation specifically incorporates dimensions such as Perceived Usefulness, Perceived Ease of Use, Perceived Security, and Perceived Trust, tailored to the REBECCA system’s objectives. SUS and UEQ questionnaires collectively assess user perceptions of the app’s utility, usability, and overall user experience Co-creation activities based on this framework involve engaging users and stakeholders through focus groups to assess user preferences, a large-scale survey collected broader data on user requirements, workshops, and testing/co-designing the app. Collaborative workshops and clinical site meetings brought together healthcare professionals and technical teams to develop behavioural indicators for cancer-related fatigue and osteoporosis and one more meeting is scheduled for March to discuss relevant indicators to peripheral neuropathy. A pilot testing scheduled for April 2022 will provide insights into the app’s usability and functionality, enabling refinements before full implementation. Additionally, to further evaluate the app’s reliability and effectiveness for real-world use, a system validation is planned for spring 2023. Finally, the development of a standardized advisory guide will ensure consistent and personalized lifestyle counselling for BCS across all clinical sites. The REBECCA project’s co-creation methodology is designed to be participatory, iterative, and evidence-based, ensuring that the resulting platform is both effective and user-friendly. By engaging a wide range of stakeholders and leveraging structured evaluation tools, the project aims to enhance the quality of life (QoL) for breast cancer survivors (BCS) and provide actionable resources for healthcare professionals. H2020SC1-DTH-12-2020 D1.2 8 | 51 1 Introduction This deliverable outlines the co-creation methodology and plan that will be implemented within the REBECCA project. The purpose of this document is to provide a comprehensive overview of the frameworks, processes, strategies, and activities involved in the co-creation efforts that have been carried out and are planned throughout the project's lifecycle. Co-creation plays a pivotal role in ensuring that the REBECCA system is developed in a way that effectively addresses the needs and perspectives of its key participants, including patients, healthcare professionals, the technical team, and other relevant parties. 1.1 Intended audience and reading suggestions The intended audience for this document includes the REBECCA project development teams, representatives of the project's end-users within the consortium, and stakeholders with backgrounds in clinical research, technology, medicine, or policy. Readers are encouraged to follow a sequential reading approach through the chapters. 1.2 Methodology Co-creation activities have been designed to involve all relevant parties to the project at every stage of development, ensuring that their insights and expertise contribute to the refinement of the system and its components. These activities, designed based on the TAM framework, include focus groups, a large-scale survey, expert workshops, clinical site meetings, testing of the app, and user experience evaluations through structured tools. The iterative nature of these processes allows for ongoing adjustments and improvements based on user feedback, ensuring that the system is aligned with the needs of all involved parties and maximizes its potential to improve patient outcomes. 1.3 Organization of the document The updated document is structured into three main sections: evaluation framework (Section 2), the co-creation activities (Section 3) and the updates and additions to co-creation activities at M39 (Section 4). Section 2 provides a description of the methodology and tools that will be employed to assess the usability, user experience, and acceptance of the REBECCA system. Section 3 outlines both the completed and planned co-creation efforts aimed at actively involving key stakeholders in the development process. Sections 2 and 3 were developed during the first version of the document (M9) and are designed to offer a comprehensive understanding of the H2020SC1-DTH-12-2020 D1.2 9 | 51 processes guiding the project’s development, with an emphasis on user-centred design and continuous improvement. Then, Section 4, which was added for the second version of the document (M39), provides an overview of both the planned activities and those conducted up to M39 that were not initially included in the co-creation activity plan. H2020SC1-DTH-12-2020 D1.2 16|51 alongside a secondary companion app. It highlighted routines and key functionalities to help participants identify priorities, constraints, and opportunities for improvement. The second scenario, “System use during a clinical meeting of a BCP and their doctor,” illustrated how the system could support doctors in gaining a detailed view of a patient’s condition before meetings, showcasing various levels of information detail. The entire scenarios are given in the Appendix of D1.1. Women of all ages who had been diagnosed with breast cancer, initiated or undergone primary breast cancer treatment, and were registered members of Amazona were invited via email to participate. The invitation email included information about the workshop, the first version of the survey questionnaire (to gather feedback for the next phase of the study), and a consent form. Participants were stratified based on age into two groups: i) above 60 and ii) 60 and below. This stratification assumed that younger individuals might be more adept at adopting new technology and that the groups would therefore have different user needs and preferences. 3.2 Focused discussions and workshops with medical experts An online workshop was held in July 2021 with members from most consortium partners, including all three clinical partners (INCLIVA, SUH, RSTO) and all technical teams, to define the system functionalities required for clinical trials. These discussions will continue throughout the project to ensure alignment with clinical needs. The workshop covered the following key goals: • Configuration and structure of clinical trials in the REBECCA system • Measurement instruments and their relation to the REBECCA Information Model • The questionnaires to be answered through the mobile app • The dashboard data views • Exporting data sets for further analysis • Open questions regarding deployment and data access The narrative scenarios created for the focus groups were also utilized in this meeting to identify key use cases of the REBECCA system in clinical practice and research. One additional narrative scenario was specifically designed to describe how the system will be used by the doctors and researchers. This scenario covered aspects such as system organization (adding BCPs, mapping studies, and CRF functionalities), design choices (data input methods, cloud-based or distributed systems), and data presentation (views, levels of detail, and comparisons between individual BCPs and population statistics). High-fidelity mock-ups and wireframes supported these discussions. H2020SC1-DTH-12-2020 D1.2 17|51 Additional details and outcomes of these decisions will be documented in Deliverable D1.4. 3.3 Large-scale questionnaire survey The survey was conducted in August 2021 and aimed to gather data on user needs and preferences. The questionnaire was electronically distributed to both BCP and BCS. Women of all ages who have been diagnosed with breast cancer and have initiated or completed primary breast cancer treatment were invited to participate in the survey. An invitation email containing information about the study and a link to the questionnaire will be sent to five breast cancer societies (Amazona, BCF Rosa Gotland, BCF Maria, BCF Moa-Lina, and Ung Cancer) in Sweden to distribute it online to their members. The questionnaire shared (Annex B.1), was a revised version of the questionnaire discussed in the co-creation workshop and was developed and administered using REDCap. It included a mix of single-choice, multiple-choice, and ranking questions, and covered multiple topics, such as demographic information, internet usage, eHealth tools, social media, and preferences related to smartphone apps, smartwatches, and companion apps. It was available in both Swedish and English. The Swedish version (Figure 5) underwent review by a group of native Swedish-speaking BCP to ensure clarity and relevance. Figure 5. Large scale survey H2020SC1-DTH-12-2020 D1.2 18|51 3.4 Co-creation meetings to develop behavioural indicators Three co-creation meetings are designed to bring together clinical and technical partners to collaboratively develop behavioural indicators for cancer-related fatigue, osteopenia/osteoporosis and peripheral neuropathy. The meetings, held online between each clinical site and AUTH, focusing on identifying and addressing the specific needs related to the health conditions assigned to each clinical site. The meeting with INCLIVA in November 2021 and with SUH in December 2021 gathered insights on relevant indicators to osteopenia/osteoporosis and treatmentinduced fatigue. The upcoming meeting at RSTO in March 2022 will address the relevant indicators to peripheral neuropathy. These meetings are essential for ensuring continuous input from all partners throughout the project’s duration, especially after each major system’s release. 3.5 Preliminary use of the system – Pilot testing A pilot testing is planned for spring 2022 and will be designed to provide insights into the app’s usability, user experience, and functionality, as well as to identify areas for improvement before broader implementation. This pilot will aim to evaluate the proposed app and compare its usage among participants between the first and second week of testing. The testing will follow a single-centre pilot design, consisting of an initial information meeting, a supervised pilot-test of the app, a follow-up meeting, and an unsupervised pilot-test of the app (Figure 6). Figure 6. Study design Inclusion criteria for participation will comprise women aged 18 years or older, able to speak and read Swedish, having completed their primary breast cancer treatment within the previous 10 years (self-reported), owning an Android or iOS smartphone, and having daily access to the internet. Exclusion criteria will include current cancer recurrence or the presence of medical conditions (e.g., dementia, anorexia) that might independently affect app usage. All participants will receive comprehensive H2020SC1-DTH-12-2020 D1.2 19|51 information about the study and will provide written informed consent prior to participating. Participants will attend an informational meeting in small groups to receive detailed guidance on study procedures and app usage. During the meeting, participants will provide written consent before gaining access to the app. Throughout the supervised one-week period, participants will use the app under guided conditions with support from researchers. Following this, a second week will allow participants to use the app freely without any guidance. A feedback questionnaire will be developed and distributed to participants during the follow-up meeting. The questionnaire will include a mix of standardized items and open-ended questions to gather user feedback on the app’s usability and functionality. 3.6 Development of individualized consultation protocol and reporting scheme To support the goal of enhancing follow-up care and QoL of BCS, KI will develop a comprehensive advisory guide to serve as a practical tool for all clinical sites, ensuring consistent and personalized lifestyle counselling for patients during intervention studies. The guide will be based on post-cancer lifestyle guidelines, drawing from international and local resources such as the WHO, WCRF, and CDC. These guidelines will be synthesized across key lifestyle areas (e.g. diet, physical activity, sleep, alcohol use, etc.) and tailored to REBECCA’s real-world data indicators. Before its finalization, the advisory guide will be shared with all project partners for feedback, suggestions, and collaborative input. The finalized advisory guide will present these recommendations in a standardized, user-friendly format, offering practical examples to address patient challenges based on collected data from the REBECCA system. 3.7 Continuous co-creation and user feedback integration Co-creation activities will be a cornerstone of the project’ss development, ensuring a user-centred approach. Amazona established a dedicated testing group to evaluate the pApp and cApp, provide detailed feedback, identify bugs, and foster collaboration. Regular weekly meetings between the technical team and Amazona will ensure seamless engagement, with a focus on planning, monitoring progress, and refining system functionalities to align with user needs and project goals. H2020SC1-DTH-12-2020 D1.2 20|51 3.8 Validation of the system A validation of the system is planned for spring 2023 to ensure the patient app’s reliability and suitability for its intended purpose. The aim will be to evaluate the app’s ability to accurately collect and analyse real-world data related to lifestyle factors, ensuring its effectiveness as a tool for personalized patient counselling. The specific methodology for validation will be decided at a later stage, based on emerging needs and the aspects that require further testing. H2020SC1-DTH-12-2020 D1.2 21|51 4 Updates and additions to co-creation activities at M39 4.1 Overview of co-creation activities This section presents the updates made to the co-creation activities up to M39, compared to the initial planning at M9. It includes an overview (Table 1) of the originally planned activities, the activities planned but not initially defined in detail (marked with * in Table 1) and the additional ones introduced (marked with bold in Table 1) during the project’s progression. Table 1. Co-Creation Activities (M9–M39) Date Month Activity June 2021 M3 Co-creation workshop / Focus groups July 2021 M4 Workshop with medical experts August 2021 M5 Large-scale survey November 2021 M8 Osteopenia / Osteoporosis meeting (INCLIVA) December 2021 M9 Treatment-Induced Fatigue (SUH) Activities after M9 March 2022 M12 Peripheral Neuropathy (RSTO) May 2022 M14 Pilot testing January - April 2023* M22-M25 cApp co-creation March 2023 M24 Norwegian Cancer Society meeting May 2023 M26 Individualized consultation protocol June 2023* M27 Validation study November 2023 M32 Positive reporting categories into the pApp April 2024 M37 Feasibility study *Activities planned in M9 but not predefined in its approach and methodology H2020SC1-DTH-12-2020 D1.2 22|51 Following the table, this section describes the methodology of the three new cocreation activities, along with the validation study and the cApp co-creation, both of which were planned in M9 but not initially defined in detail. The validation study was conducted to assess key aspects of system performance, while the cApp co-creation followed an iterative approach to finalize user requirements. The newly introduced activities (the Norwegian Cancer Society meeting, the integration of positive event reporting categories into the pApp, and the feasibility study) were designed to strengthen system validation, enhance user engagement, and refine the REBECCA system based on patient and expert feedback. A comprehensive presentation of the results from all activities described in this deliverable can be found in D1.4. 4.2 Companion App co-creation To finalize the cApp, an iterative co-creation process was conducted, integrating feedback from clinical experts, patients, and consortium members. Initially, from January to February 2023, clinical experts (including doctors, researchers, and study nurses) were asked to provide input on the in-app questions via Teamwork. These questions aimed to capture patients’ behaviour and QoL from the perspective of their companions as external observers. Subsequently, in March and April 2023, workshop activities were organized by Amazona, AUTH, and KI, engaging a focus group of six BCS members. Two iterative workshops were held to refine the cApp’s content and functionality, ensuring it aligned with user needs and clinical requirements. 4.3 Norwegian Cancer Society meeting On March 21, 2023, the Norwegian Cancer Society organized a meeting with 30 of its members to discuss the ongoing REBECCA study at SUH. The meeting aimed to present the project’s objectives and gather feedback and provided valuable insights, reaffirming the critical role of the REBECCA project in addressing unmet needs in postcancer care. 4.4 Validation study The aim of this validation study was to evaluate the functionality and accuracy of the GPS in identifying Point of Interest (PoIs), ensure proper data collection through the app and wearable devices, and gather feedback from participants to refine the process and address potential issues before conducting the intervention studies. The study protocol can be found in Annex C. H2020SC1-DTH-12-2020 D1.2 23|51 Respondents who agreed to participate in the study were invited in groups of 4 to 6 people, for a 3-hour activity. Four sessions were held, one in the morning 09:00 -12:00 and three in the evening 16:30-19:30. The validation study was conducted for three days during the week 19-22 of June 2023. The study was divided into three parts: an indoor session, an outdoor activity, and a final indoor session. It began at the Amazona head office in Stockholm, where participants were briefed on the study, trained to use an app and smartwatches, and completed a health questionnaire. The outdoor activity included a meal at a restaurant, where participants photographed their food and drink, followed by a brief stop at a shopping mall. Afterward, they returned to the office, provided feedback, and removed the watches (Figure 7). Figure 7. Study protocol 4.5 Positive reporting categories into the pApp A dedicated co-creation meeting was held with the participation of four Amazona volunteers, for integrating positive life events reporting into the pApp. This initiative builds on initial patient feedback from SUH, INCLIVA, and Amazona volunteers during the previous reporting period, where participants expressed a desire to report positive life events through the app. In response to this feedback, in September 2023 KI attempted to create positive categories for integration into the pApp. KI researchers convened a brainstorming session with 10 women from their research group to identify meaningful events that could enhance the app by better reflecting the positive and significant aspects of daily life for BCS. This process generated an extensive initial list of events, which was subsequently organized into broader domains. The list was further refined with input from consortium partners and finalized during in-depth discussions with Amazona H2020SC1-DTH-12-2020 D1.2 24|51 representatives in November 2023. The process of developing the annotation categories is depicted in Figure 8. Figure 8. Process of creating positive reporting categories into the pApp. 4.6 Feasibility study The REBECCA-KI-Feas-QoL study aims to evaluate BCS acceptance, engagement, and usage of the REBECCA system in real-world implementation, and it is conducted in the context of Task 6.1. The secondary aim of the study includes assessing QoL improvements through personalized lifestyle consultations. Over a 3-month monitoring period, the study gathers data via the REBECCA app, wearable devices and self-reports through the app, tracking participants’ physical activity, diet, emotional well-being, and internet history. The study, which began in April 2024 and will conclude in January 2025, is designed to run in two rounds with the goal of reaching 50 participants. The first round began on April 8 and will be completed in September 2024, and the second round will begin on August 26 and the data collection is expected to conclude by the end of November. Participants attend a baseline meeting at the start of the study, followed by a midpoint personalized consultation (in-person or remote), and an exit meeting at the study’s conclusion. Personalized lifestyle consultations are conducted midway through the study, informed by continuous data monitoring. Figure 9 presents the outline of the feasibility study. H2020SC1-DTH-12-2020 D1.2 25|51 Figure 9. Feasibility study design H2020SC1-DTH-12-2020 D1.2 32|51 q Fatigue/tiredness q Neuropathy q Bone health problems (osteoporosis) / joint pain q Depression q Eating disorders q Anxiety q Neurological disease q Other q I prefer not to answer q This is not relevant for me q What other health-related problems have you experienced at any time after the primary treatment? 13. Are you participating in any research / clinical study regarding breast cancer right now, or have you participated in the past? q I am participating in one or more studies right now q I have previously participated in one or more studies q I have never participated in any study q I prefer not to answer H2020SC1-DTH-12-2020 D1.2 33|51 Familiarity / experience with a particular technology This section contains questions about how familiar and experienced you are in using certain technologies. It aims to help us understand the needs of breast cancer patients and to better design and adapt the REBECCA System to your lifestyle and needs. 14. How often do you use the internet? o Daily o A few times a week o Once a week o Rarely o Never o I prefer not to answer 15. What different devices do you use to access the internet? q Android mobile q iPhone q Android tablet q iPad q Windows laptop or PC q Apple laptop or PC q I prefer not to answer q This is not relevant for me 16. Which browser do you use on your smartphone? q Google Chrome q Safari q Microsoft Edge q Mozilla Firefox q Other q I do not know q I prefer not to answer q This is not relevant for me q What other browsers do you use with your phone? 17. Which browser do you use on your android tablet / iPad? q Google Chrome q Safari q Microsoft Edge q Mozilla Firefox q Other q I do not know H2020SC1-DTH-12-2020 D1.2 34|51 q I prefer not to answer q This is not relevant for me q What other browsers do you use with your android tablet / iPad? 18. Which browser do you use on your laptop / PC (Microsoft Windows or Apple)? q Google Chrome q Safari q Microsoft Edge q Mozilla Firefox q Other q I do not know q I prefer not to answer q This is not relevant for me q What other browsers do you use with your laptop / PC (Microsoft Windows or Apple)? 19. What language do you usually use when reading / writing while you are surfing? q Swedish q English q Arabic q Spanish q Finnish q Polish q Other language What other language do you usually use when reading / writing while you are surfing? Use of social media 20. Do you use social media? o Yes o No o I prefer not to answer o This is not relevant for me 21. How do you connect to social media? q I use pre-installed apps on my device (phone, tablet, iPad) q I use a web browser (either on phone, tablet, iPad, or laptop, MacBook, PC) q I prefer not to answer q This is not relevant for me 22. What different social media platforms do you use? q Facebook H2020SC1-DTH-12-2020 D1.2 35|51 q Facebook Messenger q YouTube q Instagram q Twitter q Reddit q Quora q Medium q LinkedIn q WhatsApp q Tumblr q Pinterest q Flickr q Viber q Snapchat q Breast cancer related forums for breast cancer patients q Other q I prefer not to answer q This is not relevant for me q Which different forums for breast cancer patients do you use? q What other social media do you use? 23. What types of activities do you do via social media in relation to your breast cancer? q Chatting with friends and other cancer patients q Commenting on posts about cancer-related issues q Following other cancer patients q Posting health updates for family or friends or friends q Following patient organizations and associations related to my disease q Writing about or posting my own health-related experiences q Attending online lectures / online events related to cancer q Providing support to other breast cancer patients, either in groups or individually q Participating in breast cancer discussion groups q Other q I do nothing related to my breast cancer diagnosis q I prefer not to answer q This is not relevant for me q What other types of activities do you perform via social media that relate to your current health status? H2020SC1-DTH-12-2020 D1.2 36|51 Use of the internet 24. Where do you search for medical information online? q Google (or other search engines) q Wikipedia q YouTube q Blogs q Facebook groups q Various breast cancer related forums q 1177.se q Other q Cancer-related websites, such as the Cancer Foundation or the Breast Cancer Association q Medical databases such as PubMed q I do not seek medical information online q I prefer not to answer q This is not relevant for me Which forums do you visit to look for medical information? Where else do you look for medical information? 25. Where do you seek support and other social interactions online? q Facebook q Facebook Messenger q YouTube q Instagram q Twitter q Reddit q Quora q Medium q LinkedIn q WhatsApp q Tumblr q Pinterest q Flickr q Viber q Snapchat q Various breast cancer related forums q Other q I prefer not to answer H2020SC1-DTH-12-2020 D1.2 37|51 q This is not relevant for me What specific forums do you use to get support and other social interactions online? Where else do you seek support and other social interactions online? Online activities 26. What kind of activities do you do online in relation to your breast cancer? q Participating in virtual forums and events related to cancer q Reading about other breast cancer patients' experiences q Watching videos and the like related to cancer q Writing a diary or running a blog q Searching for medical cancer-related information q Attending training courses related to cancer q Psychotherapeutic techniques to deal with anxiety q Looking for ways to deal with emotional crisis and depression q Searches related to psychosocial problems and how to improve my mood q Participating in discussion forums related to cancer q Searching for newly available treatments q Providing support to other breast cancer patients, either in groups or individually q Searching for ongoing clinical trials for cancer q Searching for job opportunities and/or financial support for cancer survivors q Other q None of the above q I prefer not to answer q This is not relevant for me What other types of activities do you perform online in relation to your current health status? 27. How do you express your thoughts and concerns online or via social media? q I make posts via my profile to describe my concerns and problems q I share videos where I express how I feel q I only comment in private groups and forums about how I deal with my worries and problems q I join specific forums to express my anxiety and concerns q I use emojis to express how I feel q I share other people's stories about cancer to express what I feel q Other H2020SC1-DTH-12-2020 D1.2 38|51 q I don't make posts or comments about how I feel q I prefer not to answer q This is not relevant for me In what other ways do you express your thoughts and problems online or via social media? 28. How often do you use the above ways to express your thoughts, concerns and problems? o Never o Daily o Weekly o When I feel anxious or depressed o Other o I prefer not to answer o This is not relevant for me How often do you use the above ways to express your thoughts, worries and problems? Please specify: 29. Do you use (or have you used) any apps related to breast cancer? o I am currently using such an app o I have used such an app in the past o I prefer not to answer o This is not relevant for me What type of app related to cancer have you used so far? 30. Have you ever used a smartwatch or other activity bracelet? o Yes o No o I prefer not to answer o This is not relevant for me 31. What type of smartwatch / activity bracelet have you used? q Fitbit (e.g. Charge, Versa, Sense) q Garmin (e.g. Venu, Vivoactive) q Apple Watch q WearOS (Android) watch (e.g., Samsung Galaxy Watch, q Huawei Watch) q Other What type of smartwatch / activity wristband have you used? Specify brand or type. H2020SC1-DTH-12-2020 D1.2 39|51 32. Some systems (such as Google) allow you to export parts of your personal data (for example browsing history). This process usually requires a few clicks. How willing would you be to perform such a procedure (with the help of a detailed guide) every one or two months in order to provide the exported data for analysis by the REBECCA system? I would never do that ------------------------------------------------ I can easily do that H2020SC1-DTH-12-2020 D1.2 40|51 Overall questions about the REBECCA system and participation The following questions will help us to prioritize which aspects of behaviour to focus on during the development of the REBECCA system. Lifestyle questions How important are the following factors to your quality of life after completing primary breast cancer treatment? 1: Not important 7: Very important Leave it blank if it is not relevant. 33. Physical activity level (e.g., number of steps per day, number of exercise sessions, duration and intensity) 34. Dietary and nutritional habits (e.g., number of meals, snacks, time of day, irregular eating, type of food, home meals vs. restaurants vs. fast food) 35. Smoking (e.g., frequency, quantity) 36. Personal transportation (e.g., being mobile at home, ability to make leisure trips and visits to places outside the local area, performing social leisure activities such as going to reading clubs or similar) 37. Being able to spend time at home, enjoying time with pets or other quiet hobbies 38. Work (e.g., working vs. not working, working from home or office, commuting method, sick leave) 39. Social interaction, relationships with family members and friends 40. Sex drive 41. Online activities, breast cancer related activity (e.g., internet searches, online discussions, social media, various forums) H2020SC1-DTH-12-2020 D1.2 41|51 Based on the previous question, which of these factors have been significantly affected by breast cancer and breast cancer treatment? 1: not at all 7: great impact Leave it blank if it is not relevant. 42. Physical activity level (e.g., number of steps per day, number of exercise sessions, duration and intensity) 43. Dietary and nutritional habits (e.g., number of meals, snacks, time of day, irregular eating, type of food, home meals vs. restaurants vs. fast food) 44. Smoking (e.g., frequency, quantity) 45. Personal transportation (e.g., being mobile at home, ability to make leisure trips and visits to places outside the local area, performing social leisure activities such as going to reading clubs or similar) 46. Being able to spend time at home, enjoying time with pets or other quiet hobbies 47. Work (e.g., working vs. not working, working from home or office, commuting method, sick leave) 48. Social interaction, relationships with family members and friends 49. Sex drive 50. Online activities, breast cancer related activity (e.g., internet searches, online discussions, social media, various forums) H2020SC1-DTH-12-2020 D1.2 48|51 o This is not relevant for me 74. How experienced are you in using a wearable device such as a smartwatch (e.g., Android WearOS, Apple watch, Samsung smartwatch) or an activity bracelet (e.g., Fitbit Versa/Charge, Garmin band)? Never used---------------------------------------------------------------------------------- It is part of my daily routine (Place a mark on the scale above) If you are used to using a smartwatch or other activity bracelet, which features are important to you? 1: completely unimportant 7: very important Leave it blank if it is not relevant. 75. Information on physical activity such as number of steps, calories, altitude 76. Gym and training sessions 77. Heart rate monitoring 78. Sleep monitoring 79. View and / respond to messages from your phone H2020SC1-DTH-12-2020 D1.2 49|51 Companion app The Companion app is an optional component of the REBECCA system. It is a smartphone application that can be used by a selected partner of the breast cancer patient (e.g., life partner, siblings, friends) to provide additional information about the patient. The purpose is to obtain an external image of the breast cancer patient. 80. Would you like to know what kind of questions are asked in the Companion app? o Yes o No o I prefer not to answer o This is not relevant for me 81. Would you like the option to opt out of certain questions? o Yes o No o I prefer not to answer o This is not relevant to me 82. Would you like to know what your selected companion answers? o Yes o No o I prefer not to answer o This is not relevant for me 83. Would you rely on your companion to decide which questions are relevant to answer? o Yes o No o I prefer not to answer o This is not relevant to me H2020SC1-DTH-12-2020 D1.2 50|51 The best potential value of the REBECCA system The Rebecca system aims to support breast cancer patients who have completed their primary treatment in their everyday life and improve their communication with healthcare professionals. This is done by collecting information on patients' daily behaviours such as physical activity, eating habits, sleep and information related to their online behaviours. 84. How long after completion of primary treatment would the REBECCA system have been most useful and important to you? q Immediately after completion of primary treatment (0 to 6 months) q 6-12 months after completion of primary treatment q 12-24 months after completion of primary treatment q Later than 24 months after completion of q Primary treatment q I prefer not to answer q This is not relevant for me H2020SC1-DTH-12-2020 D1.2 51|51 C. ANNEX C: Validation study protocol Actions Duration Prepare – Information meeting Info for the experiment - Sign consent form 30-40 min Installation + watches distributed + instructions Fill in Health Questionnaires 15 min Data collection starts Walk to the bus stop Hälsingegatan 2 min Experiment Take the bus no 53 to the restaurant 11 min (bus ride) Go off at Centralen stop Walk to the restaurant Urban Deli https://urbandeli.se/en/sveavagen 11 min Eat lunch / dinner 30-40 min Walk from the restaurant to the metro station Hötorget 5 min Take the metro to Odenplan 4 min (bus ride) From Odenplan: Walk to Åhlens 2 min Stop: Åhlens 2 participants will enter. 3 participants wait outside 5 min at least From Åhlens walk back to Amazonas offices 8 min Take off the watches Data collection over Fill in Evaluation Questionnaires Prepare for the next day Give to take home: 1. Instructions (manually sync, etc.) 2. Chargers for the watches 3. Envelopes 4. Template for the diary TOTAL TIME Around 3 hours