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)

PLoS One. 2022 May 13;17(5):e0268091. doi: 10.1371/journal.pone.0268091. eCollection 2022.


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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Counseling
  • Delivery of Health Care*
  • Health Facilities
  • Humans
  • Neoplasms* / therapy
  • Research Design

Grants and funding

This work was supported by the Innovationsfonds of the Federal Joint Committee Berlin 2019-2022 for the area “new forms of care” (funding years: October 2019 – March 2023). Grant number: 01NVF18004. The funder of the study has no influence on the study design, data collection, analysis, interpretation, and in writing the manuscript. Since this is a government grant, there is no commercial interest.