Use of Alternative and Complementary Medicine by Colorectal Cancer Patients (ALTERNATIVCCR)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Niki CHRISTOU, MD
- Phone Number: +33 0555056730
- Email: niki.christou@chu-limoges.fr
Study Locations
-
-
-
Limoges, France, 87042
- Limoges University hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 years of age
- Diagnosed with colorectal cancer
- To be operated on between 2017 and 2022
Exclusion Criteria:
- The patient refuses to give consent to participate in the study
- Non-primary colorectal cancer (metastasis to the colon or rectum from another primary cancer; cancer originating in the appendix)
- Primary metastatic cancer other than colorectal cancer
- Discovery of cancer synchronous with colorectal cancer
- Guardianship or trusteeship
- Cognitive disorders (Alzheimer's, dementia, etc.)
- Severe psychiatric disorder (neurodevelopmental disorder, psychotic disorder, mood disorder, etc.) according to the specific DSM-5 and ICD-11 classifications
- Severe deafness (unable to answer questions during telephone interview)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Complementary and alternative medicine user
Selected patients will answer a questionnaire about their practice and habits with regard to alternative and complementary medicines.
Of these patients, 12 will also complete an additional qualitative questionnaire.
|
Selected patients will answer a questionnaire about their practice and habits with regard to alternative and complementary medicines.
Of these patients, 12 will also complete an additional qualitative questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MAC using
Time Frame: Month 2
|
Proportion of patients treated at Limoges University Hospital for colorectal cancer (CRC) using MACs
|
Month 2
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic factors
Time Frame: Month 2
|
Demographic factors associated with MAC use (Odds ratio)
|
Month 2
|
|
Clinical factors
Time Frame: month 2
|
Clinical factors associated with MAC use (Odds ratio)
|
month 2
|
|
Recurrence time
Time Frame: Month 2
|
3-year recurrence time for patients undergoing CRC surgery at Limoges University Hospital (Hazard ratio)
|
Month 2
|
|
Quality of life
Time Frame: Month 2
|
Quality of life assessed by QLQ C30 questionnaire (Odds ratio)
|
Month 2
|
|
MAC information sources
Time Frame: month 2
|
Description of MAC information sources (frequencies and percentages)
|
month 2
|
|
Reasons of using MAC
Time Frame: month 2
|
Description of the reasons why patients use or do not use these practices (frequencies and percentages)
|
month 2
|
|
Effects perceived
Time Frame: month 2
|
Description of effects perceived by MAC users (frequencies and percentages)
|
month 2
|
|
healthcare professionals' report on MAC
Time Frame: month 2
|
Description of healthcare professionals' report on MAC use (frequencies and percentages)
|
month 2
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Niki CHRISTOU, MD, University Hospital, Limoges
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 87RI24_0033 (ALTERNATIVCCR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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