NCT04299451

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started May 2020

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 11, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

March 3, 2020

Last Update Submit

January 9, 2023

Conditions

Cancer

Keywords

Alternative MedicineCancerCommunicationComplementary medicineDialogueIntegrative medicineOncology

Outcome Measures

Primary Outcomes (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)

    This instrument lists individually tailored questions assessing quality of life, including functional scales, symptom scales, global health status, and psychosocial scales.

    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).

    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).

    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.

    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).

    At baseline and 8 weeks after enrollment

  • Difference in overall survival between the two arms

    12 months after enrollment of last patient

Study Arms (2)

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.

Other: Open dialogue about CAM

Standard care

NO INTERVENTION

Standard care including referral to a homepage about complementary alternative medicine

Interventions

Open dialogue about CAMOTHER

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

Open dialogue about CAM (ODC-COC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 35470199DERIVED

MeSH Terms

Conditions

NeoplasmsCommunication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lars Henrik Jensen, MD, PhD

    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

March 3, 2020

First Posted

March 6, 2020

Study Start

May 11, 2020

Primary Completion

July 30, 2022

Study Completion

November 30, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)