Systematic development of CHEMO-SUPPORT, a nursing intervention to support adult patients with cancer in dealing with chemotherapy-related symptoms at home

Chemotherapy is associated with multiple, often distressing, side effects. The negative impact of these on quality of life is widely recognized [1, 2]. Typically, these side effects are experienced at home, in the absence of professional assistance [3]. Consequently, chemotherapy that includes ambulatory treatments forces patients to actively self-manage their symptoms. However, few patients seem to be able to do so adequately [4]. Performance of symptom self-management strategies is generally poor [5‐8]. Also, patients sub-optimally report their symptoms to healthcare professionals [9, 10]. Patients report lacking knowledge and experience [11], and report high levels of unmet needs in relation to self-care support [12]. Evidence suggests that greater symptom burden is associated with poorer self-care [8, 13].

The burden of chemotherapy-related symptoms and (often unmet) patient needs related to their self-management has catalysed the development of several new nursing interventions to address these issues [12, 14‐16]. Many have focused on managing a single symptom, such as oral mucositis or fatigue, but it is likely that meaningful improvement in quality of life can only be achieved by interventions that focus on multiple symptoms that cancer patients face [17]. Some interventions targeting multiple symptoms have indeed produced a positive impact on symptom burden [18, 19]. However, a recent systematic review revealed that these interventions have produced inconsistent results [20]. Combined with variable degrees of efficacy, many of these intervention studies face reproducibility limitations. Some studies contain little description of the studied interventions, their core components and intervention development [17, 21, 22]. The usual care that was employed for comparison is generally poorly described [20]. Intermediate outcomes, contributing to a better understanding of the effect mechanism of the intervention, are evaluated and reported in only one study [23]. Also, qualitative data on the intervention is presented in only one case [24‐27]. Consequently, many questions remain unanswered: How were outcomes reached? Which intervention components produced measurable effects and by what mechanism(s)? Also, what factors promoted or hindered their results? [28, 29].

While the systematic development of complex interventions using the best available evidence and appropriate theory is becoming increasingly encouraged and acknowledged [30‐32], such approaches are rarely applied or reported in interventions targeting chemotherapy-related symptom burden [20]. The Intervention-Mapping Approach (IM) is a conceptual framework for systematically developing healthcare programmes [33‐35]. It has been used to further advance theory and evidence-based health promotion programmes in many health domains, such as smoking cessation, preventing HIV transmission, sun protection, asthma management, etc. [34] The framework assists programme developers in making and documenting decisions for influencing change in behaviour and improving health, while making use of available evidence and theory and collaborating with future intervention providers and receivers. Using IM in intervention development is presumed to improve the potential effects of healthcare programmes [34].

This paper describes a step-by-step overview of the development of a nursing intervention aimed at reducing chemotherapy-related symptom burden. We call it CHEMO-SUPPORT. In the development process, we used the best available evidence and theory and employed the IM Approach. The second aim of this paper is to fully describe the actual intervention, as it will be implemented and studied. We used the Template for Intervention Description and Replication (TIDieR) checklist to describe our intervention. The TIDieR is presented as an extension of the CONSORT 2010 statement and the SPIRIT 2013 statement with the aim of improving the completeness of reporting and ultimately the replicability of interventions [36].

We followed the Intervention Mapping Approach of Bartholomew et al. [34] to guide development of the intervention. Table 1 summarizes the 6 steps and their specific objectives. It also provides an overview of the methods used and the results obtained at each step.

Two groups of individuals were involved throughout development of the intervention. A panel of multidisciplinary health professionals from several different centres comprised one group. This panel included 3 oncologists and 4 nurses from 3 different hospitals (1 academic and 2 non-academic); 1 general practitioner; 3 home care nurses from different primary care organisations; and 1 psychologist, with expertise in self-management of chronic disease.

The other panel of individuals included patients and caregivers. Five of them were patients who had been treated with chemotherapy, and 2 were family caregivers (spouses in both cases). They represented patients/caregivers from 3 different hospitals (1 academic and 2 non-academic). Patients were recruited with the help of nurses and doctors from the hospitals, or through self-help groups. One participating caregiver also came from a self-help group, other caregivers from a group session for partners of people with cancer.

The cancer diagnoses associated with the seven participants comprising the patient and caregiver group spanned a mix of diagnoses (haematological cancer, digestive tract cancer, breast cancer, brain tumour, and gynaecological cancer). Three patients were women and 2 were men, 1 caregiver was a man, and the remaining one was a woman. The mean age in this panel was 54 years. Patients’ age ranged from 18 to 69 years. This mix was important to achieve a diversity of perspectives [34] and to produce an intervention that is employable and generalizable to patients with cancer regardless of their demographical or clinical variables.

All panel members participated in five meetings for which they were compensated. Anonymity, confidentiality, non-binding and well-informed participation were closely guarded as ethical principles of the panel members’ involvement.

Every panel meeting had its specific objectives according to the stage in the IM process, e.g. validating the needs assessment and getting consensus about the program objective. Relevant evidence was collected in preparation for panel meetings and additional literature was searched after collaborative consultation at the meetings, when necessary. The project leader (A.C.) applied different techniques to facilitate interpersonal communication, idea generation and consensus: e.g. responding to a paper or presentation of evidence, brainstorming, nominal group technique.

In the results section, we present the outcomes and decisions made at each step of the intervention development process. Evidence and panel opinions supporting these decisions are available in Additional file 1.

We systematically developed a nursing intervention—called CHEMO-SUPPORT—aimed at reducing chemotherapy-related symptom burden that patients experience at home. This process resulted in an intervention including in-person coaching, telephone counselling, written patient information, and online/on-call access to nursing support. The intervention uses a tailored motivational approach instead of the educational approach for transferring standardized information and advice to the patient, unlike what is currently used in standard care.

Overall, earlier studies on nursing interventions targeting chemotherapy-related symptom burden have been unclear about intervention development methods [20]. Developing complex interventions using evidence and theory has been increasingly encouraged [30, 31], and by doing so, it is assumed that intervention developers improve the intervention’s potential effects. Consistent with this hypothesis, the clinical utility of using a systematic development approach for our intervention should be judged on the results of the intervention, which will be reported later. However, reporting of the intervention development process alone has merit in clarifying the chosen objectives, methods, and strategies of the intervention. This will help readers and other programme developers not only to adequately interpret intervention results but also to replicate or build on research findings and further adapt the intervention content and delivery modalities [36].

Designing interventions using IM is a time-consuming process. Yet, we believe the mandate of having a clear focus, objectives, methods, and strategies, alongside stepwise planning of the intervention and inclusion of evidence and professional and patient expertise, is crucial in shaping the intervention toward its final content. For example, the complete make-over of our standard patient information was not anticipated at the start of this study but resulted from the patient panel’s clear statement that reorientation of information material was necessary for better supporting patients in meeting their POs. As we moved through the six steps of IM, our decisions shaping the intervention were evidence- and theory-informed to the greatest extent possible. Meetings with the panels at each step of IM helped to complement the evidence with clinical and patient experience and to make clinically relevant and patient-centred decisions, all of which helped us to move forward in the development process.

It is important to note the limitations of our process of systematic intervention development and, as a consequence, of our intervention. First, social support as a determinant for adequate symptom self-management has received relatively little attention in the development of the intervention. While social support is clearly addressed in the counselling manual, the intervention could probably still benefit from better matching methods to change and mobilise social support [34, 40]. From what is known about the role of social support during treatment with chemotherapy, family caregivers’ role, as well as patients’ expectations, is very variable [45‐48]. Caregivers sometimes act as co-managers of side effects, or sometimes as coaches. However, caregivers experience the patient’s disease, treatment, and symptoms differently than the patient. So some patients feel that this difference prevents spouses and family members from developing a partnership to deal with all the burden. Also, some patients don’t feel the need to have someone support their symptom management, while others simply have no one available. More in-depth research is needed to come to a better understanding of how to engage family caregivers in the symptom management process.

Secondly, our intervention development was mainly directed at tackling patient-related determinants of poor symptom self-management. Concerning the environmental-level determinants (see Fig. 1), lack of time and concern were addressed by hiring highly motivated auxiliary nurses who believed in the value of the intervention. Thus, the decision to plan an intervention study allowed us to delay dealing with some of the environmental determinants, specifically time and attitude. These issues will surface again as we discuss the adoption and sustainability of the intervention in daily practice. However, both quantitative and qualitative evidence on CHEMO-SUPPORT will facilitate the planning of further actions towards future programme providers and policymakers.

Finally, we did not pilot test the intervention or intervention components with intended programme receivers, as is recommended as part of step 4 of IM [34]. Given the active involvement of patients as well as professionals on the one hand, and our familiarity with the implementation of interventions in this clinical domain and in this clinical setting on the other hand, we were confident that the intervention could be delivered as planned. Also, we planned thorough qualitative evaluation of the intervention alongside our quasi-experimental study. However, pilot testing remains useful for getting a sense of the possible effects, determining how the intervention is perceived by naïve patients (i.e., those who have not participated in the intervention development process), and in determining problems with implementation [34]. Ultimately, our mixed-methods evaluation will guide the revision of the intervention before further implementation.

We used the IM Approach to design a self-management intervention aimed at reducing chemotherapy-related symptom burden at home. Given the impact of chemotherapy-related symptoms and the outpatient organisation of cancer treatment, self-management is a logical goal for nursing care. However, generally poor self-management suggests that well-designed nursing interventions are imperative. The combination of evidence, theory, and clinical and patient experience in the step-by-step IM Approach resulted in a clearly described self-management support intervention to be tailored according to the patient’s self-management profile. The complete description of the intervention in this developmental study provides a foundation on which others can build on for future research and practice.