Open Dialogue About Complementary Alternative Medicine

Sponsor
Vejle Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04299451
Collaborator
(none)
207
Enrollment
1
Location
2
Arms
31.7
Anticipated Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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). 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Open dialogue about CAM
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
207 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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)
Actual Study Start Date :
May 11, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Open dialogue about CAM (ODC-COC)

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.

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

No Intervention: Standard care

Standard care including referral to a homepage about complementary alternative medicine

Outcome Measures

Primary Outcome Measures

  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) [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 Outcome Measures

  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). [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). [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. [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). [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 [12 months after enrollment of last patient]

    Kaplan-Meier survival analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Vejle HospitalVejleDenmark7100

Sponsors and Collaborators

  • Vejle Hospital

Investigators

  • Study Chair: Lars Henrik Jensen, MD, PhD, Department of Oncology, Vejle Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT04299451
Other Study ID Numbers:
  • CAMONCO 2
First Posted:
Mar 6, 2020
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vejle Hospital

Study Results

No Results Posted as of Nov 19, 2021