- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05663346
Cannabis and Cancer, an Online Training for Oncology Nurses
Evaluation of a Digital Educational Intervention Regarding Safe and Efficient Cannabis Use with Young Adults Diagnosed with Cancer: a Pilot Study
Study Overview
Status
Detailed Description
This online pilot randomized controlled trial with parallel groups is conducted in Quebec (Canada). Moodle learning management system will be used to train nurses working in oncology.
After accepting the conditions and consenting, participants will enroll in the study by providing an email address. Each participant will be validated through an email address check. After their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire.
After completing the baseline questionnaire, participants will be randomly assigned by a research assistant to the digital educational intervention (Cannabis & Cancer) or to a control group (official public websites and scientific articles).
Four weeks after the baseline questionnaire, participants will complete the online questionnaires again.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montréal, Quebec, Canada, H1T 2M4
- Hôpital Maisonneuve-Rosemont
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Work in an oncology department (eg, radio-oncology, outpatient clinics)
- Work with people diagnosed with cancer, including young adults
- Understand, read, and write French
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Cannabis & Cancer digital educational intervention
This intervention includes different asynchronous pedagogical modalities that allow, among other things, to reactivate the participants' previous knowledge and promote their autonomy in their learning process.
These modalities focus on various problems that oncology nurses may encounter about the use of cannabis in oncology (eg, how to tackle the subject, what are the correct times to approach the topic).
To this end, various pedagogical modalities that encourage the active participation of nurses are integrated into the training (eg, interactive videos, and quizzes).
Scientific articles and links to external resources (official public websites) are also included so that nurses can consult the content at their own pace.
Different aspects related to the use of cannabis are addressed in the training (eg, beneficial effects, and potential side effects).
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The Cannabis & Cancer intervention is available on Moodle learning management system in French language.
It aims to influence nurses' self-efficacy, attitudes, intentions, and knowledge regarding the safe and efficient use of cannabis by young adults diagnosed with cancer.
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Active Comparator: Standard information regarding cannabis use in oncology
The comparator is composed of an email with basic reliable non-personalized information on cannabis use in oncology (official public websites and scientific articles).
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Participants will be offered basic reliable non-personalized information on cannabis use in oncology (official public websites and scientific articles).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-efficacy
Time Frame: 4 weeks
|
The French version of the Continuing Professional Development Reaction (CPD-Reaction) questionnaire (Légaré et al., 2014) will be used. The CPD-Reaction is a 12-item theory-based self-report questionnaire designed to assess the impact of continuing professional development on different clinical practices and can be modified according to the behavior targeted by the continuing professional activity (ie, the Cannabis & Cancer intervention). It is scored using a seven-point Likert scale ranging from strongly disagree (1) to strongly agree (7). The total score can range from 3 to 21 for self-efficacy. Higher scores indicate higher levels of self-efficacy. The CPD Reaction has adequate test-retest reliability (ie, weighted kappa coefficient between 0.43-0.53 for self-efficacy). The questionnaire has good internal consistency (Cronbach's alpha = 0.84). |
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in attitudes
Time Frame: 4 weeks
|
The French version of the Continuing Professional Development Reaction (CPD-Reaction) questionnaire (Légaré et al., 2014) will be used. The CPD-Reaction is a 12-item theory-based self-report questionnaire designed to assess the impact of continuing professional development on different clinical practices and can be modified according to the behavior targeted by the continuing professional activity (ie, the Cannabis & Cancer intervention). It is scored using a seven-point Likert scale ranging from strongly disagree (1) to strongly agree (7). The total score can range from 2 to 14 for attitudes. Higher scores indicate more favorable attitudes toward the behavior. The CPD Reaction has adequate test-retest reliability (ie, weighted kappa coefficient between 0.5-0.54 for attitudes). The questionnaire has good internal consistency (Cronbach's alpha = 0.89). |
4 weeks
|
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Change in intention
Time Frame: 4 weeks
|
The French version of the Continuing Professional Development Reaction (CPD-Reaction) questionnaire (Légaré et al., 2014) will be used. The CPD-Reaction is a 12-item theory-based self-report questionnaire designed to assess the impact of continuing professional development on different clinical practices and can be modified according to the behavior targeted by the continuing professional activity (ie, the Cannabis & Cancer intervention). It is scored using a seven-point Likert scale ranging from strongly disagree (1) to strongly agree (7). The total score can range from 2 to 14 for intention. Higher scores indicate higher intentions to perform the behavior. The CPD Reaction has adequate test-retest reliability (ie, weighted kappa coefficient between 0.54-0.6 for intention). The questionnaire has good internal consistency (Cronbach's alpha = 0.79). |
4 weeks
|
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Change in knowledge
Time Frame: 4 weeks
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Nurses' knowledge will be assessed using a seven-point Likert scale (ie, 1=strongly disagree and 7=strongly agree) to be developed by the research team based on the educational content presented in the training.
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4 weeks
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Number of training modules completed by participants (objective engagement)
Time Frame: 4 weeks
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Objective data.
This data will be collected automatically when users log into the learning management system.
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4 weeks
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Frequency of viewing modules/participants (objective engagement)
Time Frame: 4 weeks
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Objective data.
This data will be collected automatically when users log into the learning management system.
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4 weeks
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Number of logins to the digital educational intervention/participant (objective engagement)
Time Frame: 4 weeks
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Objective data.
This data will be collected automatically when users log into the learning management system.
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4 weeks
|
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Time required to complete all training modules (objective engagement)
Time Frame: 4 weeks
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Objective data.
This data will be collected automatically when users log into the learning management system.
|
4 weeks
|
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Subjective engagement with the digital educational intervention
Time Frame: 4 weeks
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Subjective engagement (self-reported) will be measured using the validated French version (Fontaine et al., 2020) of the User Engagement Scale - Short Form (UES-SF) (O'Brien et al., 2018).
This 12-item instrument serves to measure four dimensions of engagement: 1) aesthetic appeal; 2) focused attention; 3) perceived usability, and 4) reward factor.
Possible answers range from strongly disagree (+1) to strongly agree (+5).
The possible total score ranges between 12 and 60.
The score for each item will be interpreted and the scores for each dimension will be compared to indicate which are rated more highly than others.
The French version shows acceptable internal consistency (ie, McDonald's omega coefficients ranging from 0.77-0.89).
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4 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Karine Bilodeau, PhD, Université de Montréal
- Principal Investigator: José Côté, Université de Montréal
- Principal Investigator: Billy Vinette, MSN, Univer
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-2802
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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