Clinical trial NCT03857776: Open Dialogue About Complementary Alternative Medicine (CAM) Integrated in Conventional Oncology Care
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Randomized controlled trial
Neoplasm
Communication
Complementary medicine
Integrative care
Integrative medicine
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in frequency of adverse events grade 3-4 between the two arms
timeFrame: 8 weeks after enrolment
Secondary outcomes:
measure: Difference in patient reported quality of life between the two arms
timeFrame: At baseline and after 12 and 24 weeks
measure: Difference in patients' evaluation of received information between the two arms
timeFrame: At baseline and after 12 and 24 weeks
measure: Difference in patient reported degree of anxiety and depression between the two arms
timeFrame: At baseline and after 12 and 24 weeks
measure: Difference in frequency of adverse events grade 3-4 between the two arms
timeFrame: At baseline and after 12 and 24 weeks
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Department of Oncology, Vejle Hospital
name: Lars Henrik Jensen
role: STUDY_CHAIR
References: