Impact of Open Dialogue about Complementary Alternative Medicine—A Phase II Randomized Controlled Trial

Abstract

Complementary alternative medicine (CAM) may reduce the symptom burden of side effects to antineoplastic treatment but also cause new side effects and non-adherence to conventional treatment. The aim of this RCT was to investigate the impact of open dialogue about complementary alternative medicine (OD-CAM) on cancer patients’ safety, health and quality of life (QoL). Patients undergoing antineoplastic treatment were randomly assigned to standard care (SC) plus OD-CAM or SC alone. The primary endpoint was frequency of grade 3–4 adverse events (AE) eight weeks after enrollment. Secondary endpoints were frequency of grade 1–4 AE, QoL, psychological distress, perceived information, attitude towards and use of CAM 12 and 24 weeks after enrollment. Survival was analyzed post hoc. Fifty-seven patients were randomized to the OD-CAM group and fifty-five to the SC group. No significant difference in frequency of grade 3–4 AEs was shown. The same applied to grade 1–4 AEs and QoL, psychological distress and perceived information. A tendency towards better QoL, improved survival and a lower level of anxiety was found in the OD-CAM group. OD-CAM is not superior to SC in reducing the frequency of AEs in patients undergoing antineoplastic treatment. OD-CAM does not compromise patient safety; it may reduce psychological stress and improve QoL and overall survival.

Multi-Institutional Analysis of Cancer Patient Exposure, Perceptions, and Trust in Information Sources Regarding Complementary and Alternative Medicine

“…Recent publications demonstrate that systematically incorporating direct dialogue regarding CAM therapy into oncology clinic visits can improve patient experience without compromising patient safety or treatment efficacy. [28][29][30] Patients are not always comfortable disclosing CAM use with their physicians, as highlighted by our finding that approximately a quarter of patients do not tell their treating oncologist of their CAM use. A recent systematic review reported a 41% weighted disclosure rate of CAM use in North America, placing the rates of disclosure found in our study much higher.…”

Efficacy of open dialogue about complementary and alternative medicine compared with standard care in improving quality of life in patients undergoing conventional oncology treatment (CAMONCO 2): protocol for a randomised controlled trial

“…OD-CAM has been developed and described in our previous study (CAMONCO 1) 32. As in CAMOCO 1, patients in the intervention group will receive SC and participate in one or two sessions on OD-CAM facilitated by a nurse-specialist, who has completed the programme Fellowship in Integrative Medicine at The University of Arizona, USA.…”

“…The nurse-specialist does not offer CAM treatments. The guideline for OD-CAM is presented in table 1, and was developed in our previous study (CAMONCO 1) 32…”

“…These studies, however, are limited by the fact that the elements of the CAM counselling were heterogeneous with no clear description, and the changes in symptoms, QoL and well-being lack comparison with a control group. In a previous phase II randomised, controlled study including 112 patients and a qualitative interview of 15 patients (The CAMONCO 1 study),32 we developed and described the intervention ‘open dialogue about CAM’ (OD-CAM). Based on a person-centred and evidence-based approach a specialist nurse guides the patient in safe and health promoting use of CAM.…”

Complementary and Integrative Approaches to Cancer: A Pilot Survey of Attitudes and Habits among Cancer Patients in Italy

“…Despite the growing interest of healthcare professionals in TCIM and the increasing number of scientifically validated studies, patients often turn to TCIM without professional input, taking information from unverifiable sources such as social networks, friends, and other patients, taking these products as self-medication [19][20][21], often underestimating the risks of adverse events, especially when taken in combination with chemotherapy (CT) [22][23][24][25]. Patients expect as main benefits a reduction of chemotherapy side effects, damage avoidance or minimization, boosting the immune system, and improvement of the response to conventional therapies [26,27].…”