Effective palliative support for people with advanced cancer and their relatives depends on addressing individual needs, preferences and wishes, with communication as a central element. The diagnosis and trajectory of advanced cancer can disrupt personhood and create diverse needs related to illness, end-of-life care, dying and death. Previous interventions have often focused on healthcare professionals, yet evidence suggests that directly supporting patients and relatives can improve participation in end-of-life discussions. eHealth approaches provide a potential avenue to deliver accessible, tailored information and to support communication and patient engagement. The ASTENZ web-based application was developed to respond to these needs and the present protocol details a feasibility study to evaluate its usability, acceptability and implementation in routine clinical care.
The trial has three principal objectives:
ASTENZ was developed by a multidisciplinary team including experts in oncology, palliative care, nursing, psychology, psychotherapy, public health, theology, medical ethics and artificial intelligence. Development drew on two preparatory works: a qualitative study of experiences and needs among patients, relatives and professionals, and a systematic review of communication needs in palliative cancer care. The app is implemented as a progressive web application, enabling use similar to a conventional mobile app without requiring a separate user account; participants receive a unique study ID to log in for the feasibility study.
The prototype comprises an introductory section and 10 chapters covering key topics identified in preliminary work. Each chapter includes multiple media formats:
To improve accessibility for users who may experience disease-related impairments, text was kept to a minimum and attention was paid to readability, colour contrast and font sizes. Two interactive functions support user engagement: the ability to create bookmarks with brief personal notes (forming a personalised list akin to a question prompt list that can be emailed for clinic preparation) and an option to share personally relevant topics or lists with the study team. When shared, a study nurse assesses needs and can facilitate referral to appropriate services or consultations.
A qualitative study conducted in advance involved in-depth interviews with advanced cancer patients (n=17), relatives (n=15) and care professionals (n=22). Analysis identified that illness can disrupt personhood and highlighted eight thematic categories—disease and therapy, structures of care, advance planning, psychological condition, dying, existential issues, communication and relationships—that informed app content. A conceptual model framed four domains for intervention: knowledge, communication, relationships and confidence. A systematic review of communication needs complemented these findings and underscored the importance of personalised, tailored approaches to end-of-life communication; these insights shaped topic selection and content presentation.
This is a single-centre, randomised, controlled, two-arm pilot trial with mixed methods elements and a realist approach. The design aims to determine feasibility and acceptability and to generate contextualised explanations of what works, for whom and under which conditions. Quantitative outcome measures will be complemented by qualitative interviews to explore user experiences and contextual factors.
Patients aged over 18 years with advanced cancer and/or their relatives will be recruited from the interdisciplinary ambulatory chemotherapy unit, the palliative care unit and the dermatology cancer unit at the University Hospital of Marburg, Germany. The planned sample size is n=171 participants (114 patients and 57 relatives). Participants will be randomly assigned in a 2:1 ratio to the intervention group (access to the ASTENZ app) or the control group (treatment as usual). Control group participants will receive access to the app after the survey period.
Primary outcomes are feasibility, usability and acceptability, measured using the System Usability Scale (SUS), MARS-G section E, technical usage data and qualitative interviews. Secondary outcomes include knowledge on end-of-life topics, confidence and readiness for end-of-life conversations, app functionality metrics, anxiety and depression, psychosocial distress, logged technical data and number of consultations initiated. Assessments are scheduled at baseline, 4 weeks and 8 weeks. Primary analyses will be descriptive to inform feasibility parameters and sample size estimations for a later effectiveness trial.
The study adopts a realist evaluation perspective to understand mechanisms and contextual conditions influencing outcomes. Quantitative analyses will primarily describe feasibility indicators, usability scores and usage metrics. Qualitative interview data will be used to explain how and why the app may be beneficial, for whom, and under what circumstances, guiding refinement of the intervention and hypotheses for subsequent trials.
Ethics approval was granted by the Ethics Committee for Human Research at Philipps University Marburg (ref. 25–292 BO). The trial is preregistered in the German Clinical Trials Register (DRKS00037577). Written informed consent will be obtained from all participants prior to inclusion. Study results will be submitted to peer-reviewed journals, presented at scientific conferences and used to inform the design of a future large-scale effectiveness trial and potential wider dissemination of the app.
Strengths include multidisciplinary, patient-centred development; explicit targeting of existential and end-of-life informational needs; and a mixed-methods, realist design that can elucidate contextual factors. The current pilot focuses on assessing the prototype’s usability, acceptability and feasibility rather than demonstrating efficacy; findings will therefore inform refinement and the planning of a larger trial to test effectiveness.
Recruitment for the feasibility trial is planned to start on 12 February 2026. The study will enrol participants according to the protocol described above and will evaluate feasibility outcomes over an 8-week assessment period.