CancerNCT03857776
Open Dialogue About Complementary Alternative Medicine (CAM) Integrated in Conventional Oncology Care
A study testing Open dialogue about complementary alternative medicine in people with Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial 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… 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 complementary alternative medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Apr 2019to 24 May 2020
- 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
- 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
Who cannot join
- -Participation in other trials
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Open dialogue about complementary alternative medicine, Standard care
- Keywords
- Randomized controlled trial, Neoplasm, Communication, Complementary medicine, Integrative care, Integrative medicine
- 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 complementary alternative medicineOther
1-hour dialogue about CAM with a nurse specialist as an Integrated part of conventional oncology care
Standard careOther
Standard care including referral to a homepage about CAM
| Study group | Role | What they receive |
|---|---|---|
| Open dialogue about CAM | Other | 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 complementary alternative medicine |
| Standard care | Other | Standard care including referral to a homepage about complementary alternative medicine Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks after enrolment
Secondary outcomes (4)
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
Measured: 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).
Measured: 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)
Measured: 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)
Measured: At baseline and after 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start5 Apr 2019
- Primary completion24 May 2020
- Study completion24 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Henrik Jensen, Study chair, Department of Oncology, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857776
- Sponsor's protocol ID
- CAMONCO
- Status last verified
- Apr 2021
- First submitted
- 22 Feb 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03857776
- Acronym / sponsor ID
- CAMONCO
- Conditions
- Cancer
- Keywords
- Randomized controlled trial, Neoplasm, Communication, Complementary medicine, Integrative care, Integrative medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 24 May 2020 (actual)
- Study completion
- 24 May 2020 (actual)
- First posted
- 28 Feb 2019 (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 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.
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 | Other | Other: Open dialogue about complementary alternative medicineParticipation 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 | Other | Other: Standard careStandard 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 (7 listed)
- 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
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 complementary alternative medicine1-hour dialogue about CAM with a nurse specialist as an Integrated part of conventional oncology care | Other | Open dialogue about CAM |
| Standard careStandard care including referral to a homepage about CAM | Other | Standard care |
Primary outcome
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)
4 secondary outcomes
Difference in patient reported quality of life between the two arms
Time frame: At baseline and after 12 and 24 weeks
Difference in patients' evaluation of received information between the two arms
Time frame: At baseline and after 12 and 24 weeks
Difference in patient reported degree of anxiety and depression between the two arms
Time frame: At baseline and after 12 and 24 weeks
Difference in frequency of adverse events grade 3-4 between the two arms
Time frame: At baseline and after 12 and 24 weeks
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 29 Apr 2021.
- 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 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 complementary alternative medicine 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 7 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 29 Apr 2021. 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 frequency of adverse events grade 3-4 between the two arms (time frame: 8 weeks after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2021.