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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.

SUBMITTER: Stie M

PROVIDER: S-EPMC8870003 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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

Stie Mette M Delmar Charlotte C Nørgaard Birgitte B Jensen Lars Henrik LH

Cancers 20220214 4

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 en ...[more]

PMID: 35205698

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Project description:IntroductionApproximately 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.Methods and analysisThe 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.Ethics and disseminationThe 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.

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:BackgroundThere is growing interest in the use of complementary and alternative medicine (CAM) throughout the world, however previous research done in Japan has focused primarily on CAM use in major cities. The purpose of this study was to develop and distribute a Japanese version of the International Complementary and Alternative Medicine Questionnaire (I-CAM-Q) to assess the use of CAM among people who visit rural Japanese family medicine clinics.MethodsUsing a Japanese version of the International Complementary and Alternative Medicine Questionnaire (I-CAM-Q), a cross-sectional survey was conducted in three rural family medicine clinics. All patients and those accompanying patients who met inclusion criteria were eligible to participate. Data were entered into SPSS Statistics and analyzed for use by age, gender, and location.ResultsOf the 519 respondents who participated in the project, 415 participants reported CAM use in the past 12 months (80.0%). When prayer is excluded, the prevalence of CAM use drops to 77.3% in the past year, or 403 respondents. The most common forms of CAM used by respondents were pain relief pads (n = 170, 32.8%), herbal medicines/supplements (n = 167, 32.2%), and massage by self or family (n = 166, 32.0%). Female respondents, individuals with higher levels of education, and those with poorer overall health status were more likely to use CAM than respondents without these characteristics. Only 22.8% of CAM therapies used were reported to physicians by survey participants.ConclusionsThese data indicate that CAM use in rural Japan is common. The results are consistent with previous studies that show that Japanese individuals are more interested in forms of CAM such as pain relief pads and massage, than in mind-body forms of CAM like relaxation and meditation. Due to the high utilization of certain CAM practices, and given that most CAM users do not disclose their CAM use to their doctors, we conclude that physicians in rural Japan would benefit by asking about CAM use during patient interviews, and by familiarizing themselves with the potential benefits and risks of commonly used CAM modalities.

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

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

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