Open Dialogue About Complementary Alternative Medicine (CAM) Integrated in Conventional Oncology Care

NCT03857776 | Completed

• 1 other identifier: CAMONCO
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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 experience better physical and mental health compared to patients in the control group receiving standard care alone.

Conditions

Cancer

Keywords

Randomized controlled trial; Neoplasm; Communication; Complementary medicine; Integrative care; Integrative medicine

Outcome Measures

Primary Outcomes (1)

• 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)

  8 weeks after enrolment

Secondary Outcomes (4)

• Difference in patient reported quality of life between the two arms

  At baseline and after 12 and 24 weeks

• Difference in patients' evaluation of received information between the two arms

  At baseline and after 12 and 24 weeks

• Difference in patient reported degree of anxiety and depression between the two arms

  At baseline and after 12 and 24 weeks

• Difference in frequency of adverse events grade 3-4 between the two arms

  At baseline and after 12 and 24 weeks

Study Arms (2)

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.

Other: Open dialogue about complementary alternative medicine

Standard care

OTHER

Standard care including referral to a homepage about complementary alternative medicine

Other: Standard care

Interventions

Open dialogue about complementary alternative medicine OTHER

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

Open dialogue about CAM

Standard care OTHER

Standard care including referral to a homepage about CAM

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participation in other trials

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Neoplasms; Communication

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lars Henrik Jensen

  Department of Oncology, Vejle Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 28, 2019
• Study Start: April 5, 2019
• Primary Completion: May 24, 2020
• Study Completion: May 24, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)