- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03539991
Developing an eLearning Program in Helping Spanish and Portuguese Speaking Cancer Care Providers During Tobacco Use Counselling
SWOG Tobacco Program for the Oncology Practice
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To develop and test the feasibility of an eLearning program on brief tobacco counseling specifically designed for Spanish- and Portuguese-speaking cancer care providers.
II. To linguistically/culturally tailor and test a mobile tool designed to assist in providing effective tobacco counseling and treatment.
OUTLINE:
Participants complete an online course focusing on different aspects of tobacco prevention and cessation over 1 hour each per week for 4 weeks. They also engage in 6 virtual meetings over 1 hour about tobacco use once per month.
After completion of study, participants are followed up at 3 and 6 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be a cancer care provider (CCP) working at one of the above cancer centers
- Have direct contact with cancer patients
- Have access to the internet during the 4-hour online course and at least once per month to participate in post-training virtual meetings, discussion board postings, email, and periodic audio chat conferences
- Have access to a computer, tablet, or smartphone (iPhone or Android) with built-in camera and microphone
- Have basic proficiency in the use of a computer, including word processing and email
- Commit to the STOP Program by completing the online course and sharing lessons learned with other CCPs at the monthly virtual meetings that will take place during the 6 months following course completion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive care (online course, virtual meeting)
Participants complete an online course focusing on different aspects of tobacco prevention and cessation over 1 hour each per week for 4 weeks.
They also engage in 6 virtual meetings over 1 hour about tobacco use once per month.
|
Ancillary studies
Complete online courses
Participate in virtual meetings
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment and retention rates
Time Frame: Up to 6 months
|
Will be used as key parameters for assessing the feasibility of the eLearning program.
The Wilcoxon signed-rank test will be used to compare scores obtained in the pre- and post-tests of the eLearning program.
Effect sizes will be computed as the absolute value of the difference between the post-test (T2, T3, and T4) and pre-test (T1) scores divided by the mean of the standard deviations for each.
|
Up to 6 months
|
|
Linguistically/culturally tailored mobile tool
Time Frame: Up to 6 months
|
Computing the System Usability Scale (SUS) scores in the final assessment will allow our research team to analyze cancer care provider's (CCPs) experience of using the tool.
A descriptive analysis to compute the SUS score will be performed and later converted to percentile ranks.
A percentile rank of 75% will indicate that the tool has high perceived usability.
All statistical analyses will be performed using SPSS Statistics version 23 (International Business Machines Corporation).
|
Up to 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gains in participants' competencies in providing smoking cessation assistance to cancer patients
Time Frame: Baseline up to 6 months
|
Will be assessed by comparing pre- and post-test responses to the International Association for the Study of Lung Cancer survey.
Item distributions, mean, median, standard deviation, minimum, maximum, and skewness will be explored.
Skewness values between -1 and 1 will be considered acceptable.
To examine reliability and internal consistency of each of the items assessing cancer care providers CCPs' competency for providing brief tobacco counseling, Cronbach's alphas will be calculated.
|
Baseline up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan Peterson, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
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
Other Study ID Numbers
- PA17-0878 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-01340 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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.