Protocol for the process evaluation of a counselling intervention designed to educate cancer patients on complementary and integrative health care and promote interprofessional collaboration in this area (the CCC-Integrativ study)

Abstract

Background Conducting a process evaluation is essential to understand how health interventions work in different healthcare settings. Particularly in the case of complex interventions, it is important to find out whether the intervention could be carried out as planned and which factors had a beneficial or hindering effect on its implementation. The aim of this study is to present the detailed protocol of the process evaluation embedded in the controlled implementation study CCC-Integrativ aiming to implement an interprofessional counselling program for cancer patients on complementary and integrative health care (CIH). Methods This mixed methods study will draw upon the “Consolidated Framework for Implementation Research” (CFIR) combined with the concept of “intervention fidelity” to evaluate the quality of the interprofessional counselling sessions, to explore the perspective of the directly and indirectly involved healthcare staff, as well as to analyze the perceptions and experiences of the patients. The qualitative evaluation phase consists of analyzing audio-recorded counselling sessions, as well as individual and group interviews with the involved persons. The quantitative evaluation phase applies questionnaires which are distributed before (T0), at the beginning (T1), in the middle (T2) and at the end (T3) of the intervention delivery. Discussion This protocol provides an example of how a process evaluation can be conducted parallel to a main study investigating and implementing a complex intervention. The results of this mixed methods research will make it possible to identify strengths and weaknesses of the team-based intervention, and to target more specifically the key factors and structures required to implement healthcare structures to meet patients’ unmet needs in the context of CIH. To our knowledge, this study is the first applying the CFIR framework in the context of interprofessional CIH counselling, and its results are expected to provide comprehensive and multidisciplinary management of cancer patients with complex supportive healthcare needs.

Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN) with Non-Pharmacological Interventions: Clinical Recommendations from a Systematic Scoping Review and an Expert Consensus Process

“…For future intervention research, the authors strongly recommend including a qualitative–quantitative process analysis running parallel to the main outcome study, so that it is possible to (1) include the perspective of the patients and the health professionals and (2) consider context and individual aspects that cannot be measured with quantitative data [ 135 ]. Another important aspect for future supportive care research, especially in the area of CIPN, is to include more patient-reported outcomes measures (PROMs, which are experienced by patients in everyday life) and patient-reported experience measures (PREMs, like patient satisfaction with conventional and complementary treatment), so that patient care interventions can be assessed in a validated and reliable way.…”