Interprofessional evidence-based counselling programme for complementary and integrative healthcare in patients with cancer: study protocol for the controlled implementation study CCC-Integrativ

Abstract

IntroductionAccording to international literature, patients with cancer wish to have information on complementary and integrative healthcare (CIH). Medical guidelines recommend actively approaching patients with cancer discussing potential benefits and risks of individual CIH methods. While some CIH methods, for example, acupuncture and yoga, have been proven effective in high-quality studies, other CIH methods lack studies or bear the risk of interactions with chemotherapeutics, for example, herbal drugs. Therefore, an evidence-based interprofessional counselling programme on CIH will be implemented at four Comprehensive Cancer Centres in the federal state of Baden-Wuerttemberg, Germany.Methods and analysisA complex intervention consisting of elements on patient, provider and system levels will be developed and evaluated within a multilayer evaluation design with confirmatory evaluation on patient level. Patients with a cancer diagnosis within the last 6 months will receive three individual counselling sessions on CIH within 3 months (=intervention on patient level). The counselling will be provided by an interprofessional team of medical and nursing staff. For this purpose, an intensive online training programme, a CIH knowledge database and an interprofessional team-building process were developed and implemented (=intervention on provider level). Moreover, training events on the basics of CIH are offered in the outpatient setting (=intervention on system level). Primary outcome of the evaluation at the patient level is patient activation measured (PAM) with the PAM-13 after 3 months. Secondary outcomes, for example, quality of life, self-efficacy and clinical parameters, will be assessed at baseline, after 3 months and at 6 months follow-up. The intervention group (n=1000) will be compared with a control group (n=500, treatment as usual, no CIH counselling. The outcomes and follow-up times in the control group are the same as in the intervention group. Moreover, the use of health services will be analysed in both groups using routine data. A qualitative-quantitative process evaluation as well as a health economic evaluation will identify relevant barriers and enabling factors for later roll-out.Ethics and disseminationThe study has been approved by the appropriate Institutional Ethical Committee of the University of Tuebingen, No. 658/2019BO1. The results of these studies will be disseminated to academic audiences and in the community.Trial registration numberDRKS00021779; Pre-results.

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)

“…Power calculation was only performed for the primary endpoint (PAM-13) of the main study [9]. Consistent data on the distribution of the primary endpoint PAM-13 is found in the literature.…”

“…For pragmatic considerations regarding the implementation character of the study (existing staff, established structures), we aim to recruit 1000 patients in the intervention group and 500 patients in the control group. With a sample size of 1500 patients (1000+500) minus 30% dropouts, a group difference of 3.2 points on the PAM-13 would have a power of 90 [9]. A power calculation for the mixed-methods process evaluation was not necessary.…”

“…Patients whose data are used for the process evaluation are oncology patients in the four participating CCCs of the intervention group. A detailed description of the inclusion and exclusion criteria can be found in the study protocol of the main study [9].…”

“…Given this situation, the study CCC-Integrativ developed an evidence-based interprofessional CIH counselling program that incorporates workforce diversity and provides patient-, provider-, and system-level interventions [9,10]. The aim of the study is to empower and inform patients in the first six months after diagnosis (including relapse or progress) by providing individual advice (3 consultation sessions within 3 months) on the opportunities and risks of CIH, to enable them to make informed decisions on whether and which CIH they wish to use.…”

“…For the individual study participant, the study lasts 6 months including a follow-up survey (intervention group and control group). Further information on the study and the outcome evaluation can be found in the protocol of the main study [9].…”