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Developing an eLearning Program in Helping Spanish and Portuguese Speaking Cancer Care Providers During Tobacco Use Counselling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539991
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This trial aims to develop an electronic learning (eLearning) program and mobile tool for Spanish and Portuguese speaking cancer care providers to use in tobacco counseling of their patients. This study may provide information for the design and implementation of tobacco cessation training programs directed to this group of professionals in low- and middle-income countries for the Latin American region.

Condition or disease Intervention/treatment Phase
Health Care Provider Other: Internet-Based Intervention Other: Meeting Other: Survey Administration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: SWOG Tobacco Program for the Oncology Practice
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : August 17, 2021
Actual Study Completion Date : August 17, 2021
Arms and Interventions
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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.
 Other: Internet-Based Intervention
Complete online courses

Other: Meeting
Participate in virtual meetings

Other: Survey Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539991


Locations
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Brazil
Hosptial de Cancer de Barretos
Barretos, Sao Paulo, Brazil, 14784
Colombia
Instituto Nacional De Cancerologia
Bogota, Colombia, 99999
Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, Lima 34
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Susan Peterson M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03539991    
Other Study ID Numbers: PA17-0878
NCI-2018-01340 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PA17-0878 ( Other Identifier: M D Anderson Cancer Center )
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No