NCT03539991

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

3.3 years

First QC Date

May 16, 2018

Last Update Submit

September 3, 2021

Conditions

Health Care Provider

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Other Outcomes (1)

  • Gains in participants' competencies in providing smoking cessation assistance to cancer patients

    Baseline up to 6 months

Study Arms (1)

Supportive care (online course, virtual meeting)

EXPERIMENTAL

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 InterventionOther: MeetingOther: Survey Administration

Interventions

Internet-Based InterventionOTHER

Complete online courses

Supportive care (online course, virtual meeting)
MeetingOTHER

Participate in virtual meetings

Supportive care (online course, virtual meeting)
Survey AdministrationOTHER

Ancillary studies

Supportive care (online course, virtual meeting)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hosptial de Cancer de Barretos

Barretos, São Paulo, 14784, Brazil

Location

Instituto Nacional De Cancerologia

Bogotá, 99999, Colombia

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

Location

Related Links

Study Officials

  • Susan Peterson

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 30, 2018

Study Start

April 18, 2018

Primary Completion

August 17, 2021

Study Completion

August 17, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations

PE(1)BR(1)CO(1)