Open Dialogue About Complementary Alternative Medicine (CAM) Integrated in Conventional Oncology Care

Cancer Clinical Trial

Official title:

A Phase Two Parallel-group Randomized Controlled Trial Assessing the Efficacy of Open Dialogue About Complementary Alternative Medicine (CAM) Integrated in Conventional Oncology Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857776
• Other study ID #: CAMONCO
• Status: Completed
• Phase: N/A
• Start date: April 5, 2019
• Est. completion date: May 24, 2020

Study information

• Verified date: April 2021
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this phase two parallel-group randomized controlled trial is to assess the efficacy of open dialogue about CAM integrated in conventional oncology care. The investigators hypothesize that patients in the intervention group participating in a scheduled open dialogue with a nurse specialist about CAM will experience better physical and mental health compared to patients in the control group receiving standard care alone.

Description:

Patients randomized to the intervention group will participate in a scheduled open dialogue about CAM with a specialist nurse, who has completed the Fellowship in Integrative Medicine at the University of Arizona. This is a training program for health professionals in empowering individuals and communities to optimize health and well-being through evidence-based, sustainable and integrative approaches. The open dialogue will be based on the fundamentals of person-centered care according to this program and include patient preferences and wishes, reliable information and counselling and advice about the potential risks and benefits of using CAM as an adjunct to conventional oncology care. All dialogue, each lasting approximately 60 minutes, will be conducted by the same nurse as soon as possible and at the latest two weeks after enrolment. According to patient needs and wishes there may be a follow-up dialogue over the telephone or in the Oncology Outpatient Clinic. The potential second dialogue is estimated to last approximately 30 minutes. Participants in the control group will receive standard information including reference to www.KABcancer.dk, which is a website presenting research on CAM, including information about its potential effects and outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 24, 2020
• Est. primary completion date: May 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or more
• Speaks and reads Danish
• Diagnosed with a new primary cancer or a relapse of cancer within the last 3 months
• Planned or initiated medical oncology treatment at the Department of Oncology, Vejle Hospital
• At least two months of oncology treatment is realistic based on clinical assessment
• Life expectancy of at least six months
• Informed consent Exclusion Criteria: -Participation in other trials

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Open dialogue about complementary alternative medicine
1-hour dialogue about CAM with a nurse specialist as an Integrated part of conventional oncology care
• Standard care
Standard care including referral to a homepage about CAM

Locations

Country	Name	City	State
Denmark	Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in frequency of adverse events grade 3-4 between the two arms	Adverse events are graded according to the Common Terminology Criteria for Adverse Events (CTCAEv5)	8 weeks after enrolment
Secondary	Difference in patient reported quality of life between the two arms	Quality of life will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30). The EORTC is composed of both multi item scales and single item measures. These include five functional scales, three symptom scales, a global health status and six single items. All of the scales and single items measures range in score from 0 to 100. A high score for functional scale represents a high/health level of functioning. A high score for the global health status represents a high quality of life. A high score for a symptom scale represents a high level of symptomatology/problems	At baseline and after 12 and 24 weeks
Secondary	Difference in patients' evaluation of received information between the two arms	Evaluation of received information will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Information Questionnaire (EORTC QLQ-INFO25).	At baseline and after 12 and 24 weeks
Secondary	Difference in patient reported degree of anxiety and depression between the two arms	Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS)	At baseline and after 12 and 24 weeks
Secondary	Difference in frequency of adverse events grade 3-4 between the two arms	Frequency of adverse events grade 3-4 will be measured by using Common Terminology Criteria for Adverse Events (CTCAEv5)	At baseline and after 12 and 24 weeks