The study was guided by the MRC Framework for developing and evaluating complex interventions [22]. Building upon a thematic synthesis of CIPN patient experience [8] and systematic review of behavioural interventions in CIPN management [21] previously conducted by the lead author, we employed Experience-Based Co-Design (EBCD) [25] as a collaborative process to systematically develop the complex intervention with patients and clinicians. This process was informed theoretically by the Common-Sense Model of Self-Regulation [26].
(1) Intervention development using the EBCD approach
Stage 1: Setting up the project
The study was conducted in oncology clinics and a chemotherapy unit at a London cancer centre. Senior clinicians and managers were involved in planning study processes and arranging access to participants. Two patients who had experienced CIPN reviewed the study protocol and ethics applications (referred to as the non-clinical CIPN expert group or NCEG).
Following ethical and site approval, convenience purposive sampling was used to approach potential patient participants. Adults diagnosed with either breast or colorectal cancer, and who were due to receive or who were actively receiving neurotoxic chemotherapy were invited to participate. Staff involved in obtaining consent and/or conducting chemotherapy-related consultations with patients were recruited. All participants signed written informed consent and had the option to attend one or more of the study activities i.e. interview, observation, and workshops (see below).
Stage 2 and 3: Engaging patients and staff and gathering their experiences
Experience data were collected through observations of chemotherapy patient-clinician consultations, clinician interviews and filmed/audio recorded patient interviews. Inductive analysis of interview and observation data was carried out. Findings have been published elsewhere (cite qual paper here).
Patient interviews were analysed thematically, edited and compiled by MT into a ‘trigger film’. This film explored key themes and issues based on the experiences of people [27] who are at risk of or already have CIPN symptoms. Fundamental to the co-design process, key ‘emotional touchpoints’ in patients’ experiences were highlighted in the trigger film [28].
Patient feedback workshop
The workshop was attended by members of the NCEG and study patient participants. Patients who were unable to attend were invited to send their comments by email. The trigger film was shown for patients to check for accuracy and resonance with their experiences, as well as to encourage further discussion (member checking) [29]. An emotional mapping exercise was facilitated by MT where patients shared how they felt as recipients of information and support for CIPN [30, 31] at different points of their treatment journey. Following discussions, participants identified key patient priorities for improvement.
Clinician feedback workshop
Thematic analysis of findings from clinician interviews were presented to clinicians, followed by discussion of the broad priorities identified in the interviews and a prioritising exercise. Participants were asked to hypothetically allocate proportions of a set amount of funds according to what they perceived should be prioritised. Further discussions resulted in a set of agreed key clinician priorities.
Stage 4: Joint workshop (co-design)
Clinician and patient group priorities were presented by a nominated representative from each group. The trigger film was then shown; the first instance for clinicians to view the film.
In three mixed patient-clinician groups, participants discussed the issues presented in the film and group priorities. Each mixed group was given printed materials describing patient and clinician priorities and was asked to discuss and then reprioritise these. They then shared their views with the larger group to agree on a final set of joint priorities.
Stage 5: Small co-design teams
Specific tasks essential to intervention development were divided among smaller co-design teams. All participants were grouped into these patient-clinician teams to work on specific tasks in an iterative design and development process. Graphic designers and a film editor who provided creative input.
Stage 6: Celebration and progression event
Ten months after the initial joint event, a celebration event was held. This was co-presented by nominated patient group representatives and clinician group representatives. The purpose of the event was to provide the study update, present the co-designed intervention, reflect upon the co-design process and inform participants of the next steps. The event was attended by patient and clinician participants, NCEG and other invited stakeholders who were not directly involved in the co-design process.
All workshops were audio-recorded and co-facilitated by MT, who has extensive facilitation experience in higher education settings. Researcher field notes and workshop transcriptions were analysed, then communicated back to the co-design teams to inform the focus of both the subsequent workshop and ongoing intervention development.
(2) Theoretical modelling using the Common-Sense Model
The use of existing theory when developing interventions is proposed within the MRC Framework [22]. During initial inductive analysis of workshop discussions and comparisons with earlier interview and observation findings, the core constructs from the Common-Sense Model of Self-Regulation (CSM) [26, 32] were recognised as relating to the discussions and outputs. CSM focuses on how individual cognitive and emotional illness representations influence action plans and behaviours for self-management [26]. Although CSM is largely used to understand perception of illness e.g. cancer, it has been used in research to understand perceptions of key symptoms such as fatigue [33] and pain [34]. CSM research has identified six cognitive illness-representations dimensions namely: identity (beliefs about how the condition is identified or labelled and symptoms associated with the label); timeline (beliefs related to how long the illness might last); consequences (beliefs about the physical and social effects of the specific health condition on them); cause (perceived reason or cause for the development of the illness); controllability (the individual’s beliefs of how much they or their treatment can manage or control the illness and its symptoms) and illness coherence (whether the person feels they have a coherent understanding of the illness) [26, 35]
Following the first joint and two succeeding workshops with smaller co-design teams, a separate online workshop was attended by patients in which participants validated the key dimensions of CSM with their CIPN experiences. Using CSM as a framework, MT deductively analysed the qualitative data and workshop discussions to understand perceptions of and coping strategies for managing CIPN. Themes were reviewed by GR and JA, followed by confirmation and sense-checking by patient participants. Our emerging analysis informed ongoing intervention modelling by the smaller co-design teams.
(3) Developing a logic model
The MRC Framework recommends a clear description of the intervention and its causal assumptions be provided [22]. We developed a logic model [36] to diagrammatically present a description of the anticipated intervention components (the intended activities), delivery mechanisms (the structures in place to deliver the intervention), mechanisms of impact (our assumptions about how the intervention will produce intended effects) and intended outcomes. Behaviour change techniques (BCT) were specified using the Behaviour Change Taxonomy version 1[37] and links between BCTs and mechanisms of action (MoA) were identified using information from a guide developed from a synthesis of BCT-MoA links as frequently described in the literature [38].
Intervention development was completed within 15 months (longer than initially planned due to the COVID-19 pandemic). Figure 1 provides an overview of the key elements of the intervention co-design process.