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NCT Number: NCT03857776

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.

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Key information

Conditions

Cancer Behavior Communication Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vejle Hospital

Vejle, 7100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open dialogue about complementary alternative medicine

Other

1-hour dialogue about CAM with a nurse specialist as an Integrated part of conventional oncology care

Standard care

Other

Standard care including referral to a homepage about CAM

Primary outcomes

  1. Difference in frequency of adverse events grade 3-4 between the two arms

    Time frame: 8 weeks after enrolment

    Adverse events are graded according to the Common Terminology Criteria for Adverse Events (CTCAEv5)

Secondary outcomes

  1. Difference in patient reported quality of life between the two arms

    Time frame: At baseline and after 12 and 24 weeks

    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

  2. Difference in patients' evaluation of received information between the two arms

    Time frame: At baseline and after 12 and 24 weeks

    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).

  3. Difference in patient reported degree of anxiety and depression between the two arms

    Time frame: At baseline and after 12 and 24 weeks

    Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS)

  4. Difference in frequency of adverse events grade 3-4 between the two arms

    Time frame: At baseline and after 12 and 24 weeks

    Frequency of adverse events grade 3-4 will be measured by using Common Terminology Criteria for Adverse Events (CTCAEv5)

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2019
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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