Open Dialogue About Complementary Alternative Medicine

NCT ID: NCT04299451

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-11

Study Completion Date

2022-11-30

Brief Summary

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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

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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

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Open dialogue about CAM

Intervention Type OTHER

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

Standard care

Standard care including referral to a homepage about complementary alternative medicine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Open dialogue about CAM

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vejle Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Henrik Jensen, MD, PhD

Role: STUDY_CHAIR

Department of Oncology, Vejle Hospital

Locations

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Vejle Hospital

Vejle, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 35470199 (View on PubMed)

Other Identifiers

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CAMONCO 2

Identifier Type: -

Identifier Source: org_study_id

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