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Feasibility of a Culturally-Specific Video Text Cessation Intervention With AA Quitline Callers

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: NCT03927976
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
Assess the feasibility and acceptability of delivering an mHealth tobacco intervention among state quitline enrollees.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Behavioral: Path2Quit - culturally specific text message intervention Not Applicable

Detailed Description:
The main objective of this study is to assess the feasibility of delivering an mHealth tobacco intervention among state quitline enrollees. This will be measured through the assessment of interest and willingness to use the video text program, and the ability to receive video text messages (i.e., has technology capable of receiving and viewing video texts. At the end of the intervention, the team will assess satisfaction and perceived helpfulness of the video-text messaging program as an indication of acceptability.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Testing the Feasibility of a Culturally-Specific Video Text Cessation Intervention With African American Quitline Callers
Actual Study Start Date : April 10, 2019
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : February 10, 2020

Arm Intervention/treatment
Experimental: Path2Quit
After assessment eligibility, given consent, information about text messaging will be collected and participants enrolled in the Path2Quit culturally specific text message program and feedback will be collected on their experience.
Behavioral: Path2Quit - culturally specific text message intervention
SMS text delivers over 6 weeks with links to 20-120 second video clips from PTF. The message library contains 155 videos and assessment questions. First message is tailored to wake-up times, and the topic of the video (e.g., Never Quit Quitting) accompanies the text. Messages are pushed to participants 1-2 times/day, with 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP). Participants also receive inquiry texts, designed to push videos of interest/relevance to the individual. The cultural adaptations are infused throughout the video segments. Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.




Primary Outcome Measures :
  1. Feasibility as measured by interest in using Path2Quit video text program [ Time Frame: Through study completion, an average of 6-weeks. ]
    The program will be evaluated as feasible if 50% of those screened are eligible and interested in the video text program AND if 90% of those who are eligible and interested in the video text program will be able to engage in the program (some may need technical assistance).


Secondary Outcome Measures :
  1. Acceptability of intervention in terms of its Satisfaction and perceived helpfulness: 6-Week Follow-Up Questionnaire [ Time Frame: 6 weeks from end of intervention ]

    Acceptability of intervention measured through a 6-Week Follow-Up Questionnaire assessing satisfaction with Path2Quit and perceived usefulness

    Program will be evaluated as 'acceptable' if 80% of those who engage in the video text program and who answer the follow-up survey will rate their satisfaction with program and usefulness of the program at 3 or higher (on 0-7 scale where 3 indicates somewhat satisfied and somewhat useful) AND 80% rate the likelihood that they would recommend to a friend at a 3 or higher (on 0-7 point scale where 3 indicates "yes, I think so").




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:   No
Criteria

Inclusion Criteria:

  • Self-identify as African American
  • Enrolled in state quitlines within the past 3 months
  • Have access to SMS texting

Exclusion Criteria:

  • Does not meet inclusion criteria

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): NCT03927976


Locations
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United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03927976    
Other Study ID Numbers: CASE1Y19
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020

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