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To co-design a nurse-led family support intervention for patients with cancer and their family members.
An intervention co-design process.
The Experience-Based Co-Design method was conducted in a hospital in northern Spain from January 2024 to February 2025 with nurses, patients and family members, following The Point of Care Foundation's eight steps: observations, individual interviews, editing the trigger film, feedback events, co-design and validation events and celebration event.
Four themes emerged from the integrated dataset. (1) Cancer: a family affair, (2) Needs of patients with cancer and their families, (3) The importance of establishing a trust-based nurse-family relationship and (4) Barriers and facilitators for a family-oriented approach in care. These findings informed feedback events where stakeholders identified critical intervention areas, including family support, illness communication, emotional expression and the importance of trust. Based on these results, the Family CARE-ON intervention was structured around three core components: Engaging, Supporting and Empowering.
This study highlights the value of the Experience-Based Co-Design methodology, with active engagement from stakeholders, to develop a family support intervention in oncology care. Further research is needed to evaluate the feasibility and effectiveness, as well as to explore the implementation and scalability of the intervention in oncological settings.
Co-designing a family support intervention together with stakeholders ensures alignment with their needs and expectations, while also fostering the feasibility of the intervention in clinical practice.
The results show how stakeholders co-designed a family support intervention, drawing from their own experiences and perspectives on the impact of cancer on the family.
Guidance for reporting intervention development studies in health research (GUIDED) and Template for Intervention Description and Replication (TIDieR).
Nurses, patients and family members were involved in designing the family support intervention.
To investigate the experience with and progress of the implementation of a Family Support Intervention (FSI) into adult intensive care units (ICUs) as part of the cluster-randomised FICUS trial.
A mixed-methods process evaluation using a multiple case study approach guided by the normalisation process theory.
This study took place between June 2022 and July 2023 in eight Swiss ICUs randomised to the intervention arm. A tailored implementation strategy was used to introduce the multicomponent FSI, consisting of a new family nursing role and a family care pathway, into interprofessional ICU teams. Participants were 40 ICU key clinical partners. Qualitative data were collected twice, early (3–6 months) and mid-implementation (9–12 months), using small group interviews. A questionnaire with psychometric measures (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Intervention Appropriateness Measure, Normalisation Measure Development Questionnaire) was administered at mid-implementation. RITA pragmatic rapid thematic analysis and descriptive statistics were used to analyse the data. Qualitative and quantitative results were then compared across ICUs (cases).
Findings indicated the desired progress of the FSI integration overall and across cases, with high acceptability and appropriateness ratings but only moderate to high feasibility scores. Study-related barriers were noted in all ICUs (i.e., FSI delivery as part of a clinical trial). Implementation barriers included family nurses' limited capacity and clinician's attitudes towards the FSI. Leadership support and interprofessional collaboration were identified as facilitators. Case-based, integrated findings yielded two implementation pathways, namely early and protracted adopters.
Implementation barriers were related to the feasibility of FSI delivery within the study context that required a high degree of standardisation and protocol adherence. Implementation progress was shaped by an interprofessional culture of family care, sufficient staff and time resources, and leadership support. The study's findings will inform future implementation of complex health interventions in ICUs.
Good reporting of a Mixed-Methods Study (GRAMMS).
Within the FICUS trial, a patient and family advisory board with a patient expert, three family members and a patient with own lived experience of critical care collaborate with the research team.
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