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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Open dialogue about complementary alternative medicine; Other: Standard care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Vejle, Denmark, 7100
    • Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open dialogue about CAM; Participation in an open dialogue about CAM with a nurse specialist. The dialogue will be based on the fundamentals of person-centered care and include patient preferences and wishes, reliable information and counselling, and advice about the potential risks and benefits of using CAM. The dialogue is estimated to last approximately 60 minutes and all dialogues will be conducted by the same nurse. Depending on patient needs and wishes there may be a follow-up consultation one month after the first dialogue.	Other: Open dialogue about complementary alternative medicine; 1-hour dialogue about CAM with a nurse specialist as an Integrated part of conventional oncology care
Other: Standard care; Standard care including referral to a homepage about complementary alternative medicine	Other: Standard care; Standard care including referral to a homepage about CAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Study Chair: Lars Henrik Jensen, Department of Oncology, Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Actual): May 24, 2020
• Study Completion (Actual): May 24, 2020

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Integrative care; Neoplasm; Communication; Integrative medicine; Complementary medicine
• Other Study ID Numbers: CAMONCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No