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Cannabis and Cancer, an Online Training for Oncology Nurses

Primary Purpose

Cannabis Use, Cannabis Use, Unspecified, Nurse's Role

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cannabis & Cancer digital educational intervention
Standard information regarding cannabis use in oncology
Sponsored by
Ciusss de L'Est de l'Île de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cannabis Use

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cannabis & Cancer digital educational intervention

    Standard information regarding cannabis use in oncology

    Arm Description

    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).

    The comparator is composed of an email with basic reliable non-personalized information on cannabis use in oncology (official public websites and scientific articles).

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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).
    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).
    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.
    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.
    Frequency of viewing modules/participants (objective engagement)
    Objective data. This data will be collected automatically when users log into the learning management system.
    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.
    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.
    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).

    Full Information

    First Posted
    December 15, 2022
    Last Updated
    August 22, 2023
    Sponsor
    Ciusss de L'Est de l'Île de Montréal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05663346
    Brief Title
    Cannabis and Cancer, an Online Training for Oncology Nurses
    Official Title
    Evaluation of a Digital Educational Intervention Regarding Safe and Efficient Cannabis Use With Young Adults Diagnosed With Cancer: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ciusss de L'Est de l'Île de Montréal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cannabis Use, Cannabis Use, Unspecified, Nurse's Role, Oncology Pain, Symptoms and Signs

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cannabis & Cancer digital educational intervention
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Standard information regarding cannabis use in oncology
    Arm Type
    Active Comparator
    Arm Description
    The comparator is composed of an email with basic reliable non-personalized information on cannabis use in oncology (official public websites and scientific articles).
    Intervention Type
    Other
    Intervention Name(s)
    Cannabis & Cancer digital educational intervention
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Standard information regarding cannabis use in oncology
    Intervention Description
    Participants will be offered basic reliable non-personalized information on cannabis use in oncology (official public websites and scientific articles).
    Primary Outcome Measure Information:
    Title
    Change in self-efficacy
    Description
    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).
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Change in attitudes
    Description
    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).
    Time Frame
    4 weeks
    Title
    Change in intention
    Description
    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).
    Time Frame
    4 weeks
    Title
    Change in knowledge
    Description
    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.
    Time Frame
    4 weeks
    Title
    Number of training modules completed by participants (objective engagement)
    Description
    Objective data. This data will be collected automatically when users log into the learning management system.
    Time Frame
    4 weeks
    Title
    Frequency of viewing modules/participants (objective engagement)
    Description
    Objective data. This data will be collected automatically when users log into the learning management system.
    Time Frame
    4 weeks
    Title
    Number of logins to the digital educational intervention/participant (objective engagement)
    Description
    Objective data. This data will be collected automatically when users log into the learning management system.
    Time Frame
    4 weeks
    Title
    Time required to complete all training modules (objective engagement)
    Description
    Objective data. This data will be collected automatically when users log into the learning management system.
    Time Frame
    4 weeks
    Title
    Subjective engagement with the digital educational intervention
    Description
    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).
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karine Bilodeau, PhD
    Phone
    514 343-6437
    Email
    karine.bilodeau.2@umontreal.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karine Bilodeau, PhD
    Organizational Affiliation
    Université de Montréal
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    José Côté
    Organizational Affiliation
    Université de Montréal
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Billy Vinette, MSN
    Organizational Affiliation
    Univer
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cannabis and Cancer, an Online Training for Oncology Nurses

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