CancerNCT04299451
Open Dialogue About Complementary Alternative Medicine
A study testing Open dialogue about CAM in people with Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Open dialogue about CAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteDenmark
- Study dates
- 11 May 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Participation in other trials
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- Open dialogue about CAM
- Keywords
- Alternative Medicine, Cancer, Communication, Complementary medicine, Dialogue, Integrative medicine, Oncology
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open dialogue about CAMOther
1-hour dialogue about CAM with a nurse specialist as an integrated part of conventional oncology care
| Study group | Role | What they receive |
|---|---|---|
| Open dialogue about CAM (ODC-COC) | Experimental | 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. Receives: Other: Open dialogue about CAM |
| Standard care | No intervention | Standard care including referral to a homepage about complementary alternative medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
This instrument lists individually tailored questions assessing quality of life, including functional scales, symptom scales, global health status, and psychosocial scales.
Measured: 8 weeks after enrollment
Secondary outcomes (5)
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).
This instrument lists individually tailored questions assessing quality of life, including functional scales, symptom scales, global health status, and psychosocial scales.
Measured: At baseline and after 12 and 24 weeks
Difference in patient reported level of depression and anxiety between the two arms as measured by the Hospital Anxiety and Depression Scale (HADS).
With 14 questions this instrument assesses the symptom severity and caseness of anxiety disorders and depression.
Measured: At baseline and 8, 12 and 24 weeks after enrollment
Difference in patient reported top concerns in the two arms as measured by the Measure Yourself Concerns and Wellbeing (MYCaW) questionnaire.
This instrument assesses the level of severity of the two most pressing concerns and present overall well-being
Measured: At baseline and 8, 12 and 24 weeks after enrollment
Difference in patient reported decision regret in the two arms as measured by the Decision Regret Scale (DRS).
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.
Measured: At baseline and 8 weeks after enrollment
Difference in overall survival between the two arms
Kaplan-Meier survival analysis
Measured: 12 months after enrollment of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start11 May 2020
- Primary completion30 Jul 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Henrik Jensen, MD, PhD, Study chair, Department of Oncology, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299451
- Sponsor's protocol ID
- CAMONCO 2
- Status last verified
- Jan 2023
- First submitted
- 3 Mar 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stie M, Delmar C, Norgaard B, Jensen LH. Efficacy of open dialogue about complementary and alternative medicine compared with standard care in improving quality of life in patients undergoing conventional oncology treatment (CAMONCO 2): protocol for a randomised controlled trial. BMJ Open. 2022 Apr 25;12(4):e059960. doi: 10.1136/bmjopen-2021-059960.
PubMed 35470199
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04299451
- Acronym / sponsor ID
- CAMONCO 2
- Conditions
- Cancer
- Keywords
- Alternative Medicine, Cancer, Communication, Complementary medicine, Dialogue, Integrative medicine, Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open dialogue about CAM (ODC-COC) | Experimental | Other: Open dialogue about CAMParticipation 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. |
| Standard care | No intervention | –Standard care including referral to a homepage about complementary alternative medicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- -Participation in other trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open dialogue about CAM1-hour dialogue about CAM with a nurse specialist as an integrated part of conventional oncology care | Other | Open dialogue about CAM (ODC-COC) |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
Difference in overall survival between the two arms
Time frame: 12 months after enrollment of last patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 35470199Stie M, Delmar C, Norgaard B, Jensen LH. Efficacy of open dialogue about complementary and alternative medicine compared with standard care in improving quality of life in patients undergoing conventional oncology treatment (CAMONCO 2): protocol for a randomised controlled trial. BMJ Open. 2022 Apr 25;12(4):e059960. doi: 10.1136/bmjopen-2021-059960.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Henrik Jensen, MD, PhD study chair
Department of Oncology, Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open dialogue about CAM in people with Cancer, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04299451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.