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Towards an open and effective dialogue on complementary medicine in oncology: protocol of patient participatory study 'COMMON'.

ABSTRACT: Approximately half of patients with cancer use some form of complementary medicine alongside conventional cancer treatment. The topic of complementary medicine often remains undiscussed in consultations between patients with cancer and their healthcare providers. This results in increased risks for adverse or interaction effects and decreased access to the benefits of evidence-based complementary medicine for patients with cancer. This paper describes the design of patient participatory study titled 'COMMON' that aims to explore and enhance open and effective communication about complementary medicine in oncology. The study is carried out in collaboration with 12 (former) patients with breast cancer as coresearchers. The study complies with the six steps of the intervention mapping framework. Three non-academic hospitals recruit participants (patients with cancer, oncology healthcare providers and managers) for interviews about the organisation, experiences and needs regarding complementary medicine. To assess communication about complementary medicine, recorded oncology consultations are analysed. For an overview of evidence-based complementary medicine available to patients with cancer, a review of reviews is conducted on the evidence on cancer patient-reported outcomes of complementary medicine frequently used by patients with cancer, supplemented with an online search and survey among organisations and persons providing complementary medicine to patients with cancer. Together, these steps generate input for the development of a toolbox that supports an open and effective discussion on complementary medicine in oncology. In a pilot study, acceptability and usability of the toolbox are assessed among patients with cancer and oncology healthcare providers. Dissemination of the toolbox is covered by the commitment of stakeholder parties. The Medical Ethics Committee Arnhem-Nijmegen declared the study was exempted from formal approval under the Dutch Medical Research Involving Human Subjects Act. The results will be disseminated through open-access, peer-reviewed publications, stakeholder-reporting and presentations at relevant conferences.

SUBMITTER: Mentink M

PROVIDER: S-EPMC8529983 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionComplementary and alternative medicine (CAM) has been shown to reduce symptoms and adverse effects and improve quality of life of patients undergoing conventional oncology treatment, but CAM might also cause symptoms and adverse effects such as headache and fatigue. Thus, patients need guidance towards safe and healthy use of CAM. According to published results, open dialogue about CAM (OD-CAM) between health professionals and patients as an integral part of anticancer treatment may improve patients' quality of life and well-being. Since the literature on the issue is sparse, the aim of this study is to assess the efficacy of OD-CAM integrated early in conventional oncology treatment versus standard care (SC) in patients undergoing standard anticancer treatment.Methods and analysisThe study is a randomised controlled trial, being conducted at an oncology outpatient clinic in Denmark. 207 patients undergoing curative or palliative oncology treatment for breast, gynaecological, prostate, pulmonary, colorectal, anal or pancreatic cancer will be randomly assigned to SC with or without OD-CAM. A nurse specialist will facilitate the OD-CAM in one or two sessions. The primary endpoint is patient reported quality of life in relation to psychological well-being 8 weeks after enrollment. Secondary endpoints are patient reported level of depression and anxiety, top concerns, and decision regret 8, 12 and 24 weeks after enrolment, and overall survival.Ethics and disseminationAccording to the Committee on Health Research Ethics for Southern Denmark, ethics approval of this study is not required (S-20202000-5, 20/1019). The Region of Southern Denmark (Journal no. 20/11100) approved the storing and handling of data. Participants' informed consent will be obtained before inclusion and randomisation. The results of the study, whether positive, negative or inconclusive, will be disseminated through open-access, peer-reviewed publications, stake-holder-reporting and presentations at relevant conferences.Trial registration numberNCT04299451.

Project description:BackgroundOut-of-pocket expenditures of over 34 billion dollars per year in the US are an apparent testament to a widely held belief that complementary and alternative medicine (CAM) therapies have benefits that outweigh their costs. However, regardless of public opinion, there is often little more than anecdotal evidence on the health and economic implications of CAM therapies. The objectives of this study are to present an overview of economic evaluation and to expand upon a previous review to examine the current scope and quality of CAM economic evaluations.MethodsThe data sources used were Medline, AMED, Alt-HealthWatch, and the Complementary and Alternative Medicine Citation Index; January 1999 to October 2004. Papers that reported original data on specific CAM therapies from any form of standard economic analysis were included. Full economic evaluations were subjected to two types of quality review. The first was a 35-item checklist for reporting quality, and the second was a set of four criteria for study quality (randomization, prospective collection of economic data, comparison to usual care, and no blinding).ResultsA total of 56 economic evaluations (39 full evaluations) of CAM were found covering a range of therapies applied to a variety of conditions. The reporting quality of the full evaluations was poor for certain items, but was comparable to the quality found by systematic reviews of economic evaluations in conventional medicine. Regarding study quality, 14 (36%) studies were found to meet all four criteria. These exemplary studies indicate CAM therapies that may be considered cost-effective compared to usual care for various conditions: acupuncture for migraine, manual therapy for neck pain, spa therapy for Parkinson's, self-administered stress management for cancer patients undergoing chemotherapy, pre- and post-operative oral nutritional supplementation for lower gastrointestinal tract surgery, biofeedback for patients with "functional" disorders (eg, irritable bowel syndrome), and guided imagery, relaxation therapy, and potassium-rich diet for cardiac patients.ConclusionWhereas the number and quality of economic evaluations of CAM have increased in recent years and more CAM therapies have been shown to be of good value, the majority of CAM therapies still remain to be evaluated.

Project description:IntroductionTo understand if and which patients would be open-minded to Complementary and Alternative Medicine (CAM) use parallel to their oncological treatment. Moreover, we sought to determine which methods are most accepted and which are the primary motivators to use CAM.MethodsWe developed and anonymously conducted a questionnaire for patients in the oncology center (TU Munich). Questions focus on different CAM methods, previous experiences, and willingness to apply or use CAM when offered in a university-based setting.ResultsA total of 171 of 376 patients (37.4% women, 62.0% men, 0.6% unknown) participated. This corresponds to a return rate of 45%. Median age was 64 years (17-87 years). Of all participants, 15.2% used CAM during their oncological therapy; 32.7% have used it in the past. The majority (81.9%) was not using CAM during therapy; 55.5% have not used CAM in the past respectively. The analysis revealed a significant correlation between education and CAM use during therapy (r = 0.18; p = 0.02), and CAM use in the past (r = 0.17; p = 0.04). Of all patients using CAM during therapy, favored methods were food supplements (42.3%), vitamins/minerals (42.3%), massage (34.6%). Motivations are especially the reduction of side effect and stress, the positive effect of certain CAM-treatments on the immune system and tumor therapy. Results showed no difference between women and men. Most patients not having had any experience with CAM complain about the deficiency of information by their treating oncologist (31.4%) as well as missing treatment possibilities (54.3%).ConclusionSince many patients believe in study results demonstrating the efficacy of CAM, it stresses our task to develop innovative study protocols to investigate the outcomes of certain CAM on symptom reduction or other endpoints. Thus, prospective trials and innovative evidence-based treatment concepts to include CAM into high-end oncology is what patients demand and what a modern oncology center should offer.

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Towards an open and effective dialogue on complementary medicine in oncology: protocol of patient participatory study 'COMMON'.

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