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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03539991
Other study ID # PA17-0878
Secondary ID NCI-2018-01340PA
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2018
Est. completion date August 17, 2021

Study information

Verified date September 2021
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date August 17, 2021
Est. primary completion date August 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Internet-Based Intervention
Complete online courses
Meeting
Participate in virtual meetings
Survey Administration
Ancillary studies

Locations

Country Name City State
Brazil Hosptial de Cancer de Barretos Barretos Sao Paulo
Colombia Instituto Nacional De Cancerologia Bogota
Peru Instituto Nacional de Enfermedades Neoplasicas Lima

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Countries where clinical trial is conducted

Brazil,  Colombia,  Peru, 

Outcome

Type Measure Description Time frame Safety issue
Other Gains in participants' competencies in providing smoking cessation assistance to cancer patients 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
Primary Recruitment and retention rates 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
Primary Linguistically/culturally tailored mobile tool 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
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