Health Care ProviderNCT03539991
Developing an eLearning Program in Helping Spanish and Portuguese Speaking Cancer Care Providers During Tobacco Use Counselling
A study testing Internet-Based Intervention, Meeting and Survey Administration in people with Health Care Provider, run by M.D. Anderson Cancer Center at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Provider
- What is being tested?
- Internet-Based Intervention, Meeting and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 18 Apr 2018to 17 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: SWOG Tobacco Program for the Oncology Practice
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Health Care Provider
- Being tested
- Internet-Based Intervention, Meeting, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Complete online courses
MeetingOther
Participate in virtual meetings
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Internet-Based Intervention; Other: Meeting; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start18 Apr 2018
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care ProviderStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan Peterson, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539991
- Sponsor's protocol ID
- PA17-0878
- Other IDs
- NCI-2018-01340, PA17-0878
- Status last verified
- Sep 2021
- First submitted
- 16 May 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWOG Tobacco Program for the Oncology Practice
- ClinicalTrials.gov ID
- NCT03539991
- Acronym / sponsor ID
- PA17-0878
- Conditions
- Health Care Provider
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (online course, virtual meeting) | Experimental | Other: Internet-Based Intervention, Other: Meeting, Other: Survey AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionComplete online courses | Other | Supportive care (online course, virtual meeting) |
| MeetingParticipate in virtual meetings | Other | Supportive care (online course, virtual meeting) |
| Survey AdministrationAncillary studies | Other | Supportive care (online course, virtual meeting) |
Primary outcome
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Peterson principal investigator
M.D. Anderson Cancer Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Meeting and Survey Administration in people with Health Care Provider, run by M.D. Anderson Cancer Center at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Colombia, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rates (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.