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NCT Number: NCT04299451

Open Dialogue About Complementary Alternative Medicine

The purpose of this phase III parallel-group randomized controlled trial is to assess the efficacy of open dialogue about complementary alternative medicine integrated in conventional oncology care (ODC-COC). The investigators hypothesize that patients in the intervention group participating in an ODC-COC with a nurse specialist report better quality of life 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 ODC-COC 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 ODC-COC 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 complementary alternative medicine as an adjunct to conventional oncology care.

The dialogue lasts approximately 60 minutes and will take place as soon as possible and no later than two weeks after enrolment. The same nurse will conduct all dialogues. 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

  • 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 CAM

Other

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

Primary outcomes

  1. Difference in patient reported quality of life between the two arms at 8 weeks as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ CAT core)

    Time frame: 8 weeks after enrollment

    This instrument lists individually tailored questions assessing quality of life, including functional scales, symptom scales, global health status, and psychosocial scales.

Secondary outcomes

  1. Difference in patient reported quality of life between the two arms at 12 and 24 weeks as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ CAT Core).

    Time frame: At baseline and after 12 and 24 weeks

    This instrument lists individually tailored questions assessing quality of life, including functional scales, symptom scales, global health status, and psychosocial scales.

  2. Difference in patient reported level of depression and anxiety between the two arms as measured by the Hospital Anxiety and Depression Scale (HADS).

    Time frame: At baseline and 8, 12 and 24 weeks after enrollment

    With 14 questions this instrument assesses the symptom severity and caseness of anxiety disorders and depression.

  3. Difference in patient reported top concerns in the two arms as measured by the Measure Yourself Concerns and Wellbeing (MYCaW) questionnaire.

    Time frame: At baseline and 8, 12 and 24 weeks after enrollment

    This instrument assesses the level of severity of the two most pressing concerns and present overall well-being

  4. Difference in patient reported decision regret in the two arms as measured by the Decision Regret Scale (DRS).

    Time frame: At baseline and 8 weeks after enrollment

    This instrument consists of 5 items elucidating if regret is present, whether the decision is the right one, and whether the patient would make the same decision again.

  5. Difference in overall survival between the two arms

    Time frame: 12 months after enrollment of last patient

    Kaplan-Meier survival analysis

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

The Efficacy of Open Dialogue About Complementary Alternative Medicine Integrated in Conventional Oncology Care. Patient Reported Quality of Life and Well-being (CAMONCO 2)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2020
Registry last updated
Jan 10, 2023

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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