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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05663346
Other study ID # 2022-2802
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 4, 2024
Est. completion date November 2024

Study information

Verified date February 2024
Source Ciusss de L'Est de l'Île de Montréal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the preliminary effects and impacts of a digital educational intervention to support nurses' professional practice regarding safe cannabis use by young adults (18-39 years) diagnosed with cancer.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date November 2024
Est. primary completion date March 18, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
Cannabis & Cancer digital educational intervention
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.
Standard information regarding cannabis use in oncology
Participants will be offered basic reliable non-personalized information on cannabis use in oncology (official public websites and scientific articles).

Locations

Country Name City State
Canada Hôpital Maisonneuve-Rosemont Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Ciusss de L'Est de l'Île de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in self-efficacy 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 Change in attitudes 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
Secondary Change in intention 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
Secondary Change in knowledge 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. 4 weeks
Secondary Number of training modules completed by participants (objective engagement) Objective data. This data will be collected automatically when users log into the learning management system. 4 weeks
Secondary Frequency of viewing modules/participants (objective engagement) Objective data. This data will be collected automatically when users log into the learning management system. 4 weeks
Secondary Number of logins to the digital educational intervention/participant (objective engagement) Objective data. This data will be collected automatically when users log into the learning management system. 4 weeks
Secondary Time required to complete all training modules (objective engagement) Objective data. This data will be collected automatically when users log into the learning management system. 4 weeks
Secondary Subjective engagement with the digital educational intervention 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). 4 weeks
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