Tobacco Use CessationNCT03064971
Enhancing Quitline Services for African American Smokers
A study testing smoking cessation DVD and PTF DVD in people with Tobacco Use Cessation, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study proposes to test the value of a culturally specific program for African American smokers to quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- smoking cessation DVD and PTF DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 24 Jun 2020
- 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
- Self-identification as Black/African American
- Current smokers (smoked at least 100 lifetime cigarettes and currently smoke on some or every day) who would like help quitting
- Eligible for state quitline services
- Access to devices that play DVDs
- Permanent contact information
Who cannot join
- Recent quitters (have not smoked in past 7 days)
- Medical contraindications for nicotine replacement therapy (NRT)
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Enhancing Quitline Services for African American Smokers: RCT of an Evidence-Based DVD
This study proposes to test the value of a culturally specific program for African American smokers to quit smoking.
Read the detailed description
The intervention to be tested, Pathways to Freedom (PTF), is a video-based program that will be examined as an adjunct to tobacco cessation services provided through a state quitline. Investigators will conduct a 3-arm randomized controlled trial (RCT) to obtain real-world evidence for the efficacy of the PTF DVD. Participants will be randomly assigned to receive standard care plus PTF DVD, standard care plus standard smoking cessation DVD, or standard care only; assessments will occur at baseline, 3, and 6 months post-enrollment. All participants will receive nicotine replacement therapy (NRT). Thus, the impact of the PTF DVD will be isolated, informing investigators whether standard telephone counseling can be enhanced by the provision of a culturally specific DVD-based intervention. The primary abstinence outcome will be cotinine-verified 7-day point-prevalence abstinence (ppa) at the 6-month follow-up; secondary outcomes will be 7-day ppa at 3-months, 24-hour ppa, and 28-day continuous abstinence.
Objective 1: To test the efficacy of an innovative evidence-based smoking cessation DVD targeting African American smokers. Investigators will conduct a 3-arm randomized controlled trial (RCT) to obtain real-world evidence for the efficacy of the Pathway to Freedom (PTF) DVD. Participants will be randomly assigned to receive standard care plus PTF DVD, standard care plus standard smoking cessation DVD, or standard care only; assessments will occur at baseline, 3, and 6 months post-enrollment. All participants will receive nicotine replacement therapy (NRT). Thus, the impact of the PTF DVD will be isolated, informing us of whether standard telephone counseling can be enhanced by the provision of a culturally specific DVD-based intervention. The primary abstinence outcome will be cotinine-verified 7-day point-prevalence abstinence (ppa) at the 6-month follow-up; secondary outcomes will be 7-day ppa at 3-months, 24-hour ppa, and 28-day continuous abstinence. Controlling for covariates (any group differences in socio-demographics, smoking history, and NRT use), the study hypothesizes that standard care plus the PTF DVD will produce greater abstinence rates compared to standard care plus a standard cessation DVD. In this study, it is also expect that the greater abstinence rates in the PTF DVD condition will be maintained over time.
Objective 2: To examine the effect of the PTF DVD on treatment engagement. Previous research suggests that culturally specific interventions are preferred by African American smokers compared to standard interventions. This preference may impact engagement in treatment, which would also represent an important indicator of success. Controlling for baseline differences, this study hypothesizes that the PTF DVD will lead to greater engagement in treatment, specifically positive evaluations of the telephone counseling and smoking cessation DVDs, session length, completed counseling sessions, DVD viewing, NRT use, use of coping strategies, and study retention compared to the standard DVD control group.
Objective 3 (exploratory): To assess the feasibility of delivering the PTF DVD in an online format. Although there are several indications that a DVD format is cutting edge for African American smokers, who tend to be of lower socioeconomic status and have less Internet access, the study will assess the acceptability and utilization of delivering the video interventions in an online format. Specifically, at the 3 and 6-month follow-ups, participants will rate their satisfaction and experience with accessing the videos in each condition via a private YouTube channel, and report the frequency of online viewing. As this is an exploratory aim, there is no specific hypotheses.
- Conditions
- Tobacco Use Cessation
- Being tested
- Standard Care, smoking cessation DVD, PTF DVD
- Keywords
- Quitline, culturally specific
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareBehavioural
Standard of care provided by QuitlineNC includes Quit Coaches, counseling calls, nicotine replacement therapy, and written materials
smoking cessation DVDBehavioural
The evidence-based "How to Quit" DVD contains 60 minutes of smoking cessation information and strategies
PTF DVDBehavioural
Also called Pathways to Freedom DVD
Culturally specific smoking cessation DVD. This DVD contains 60 minutes of material.
| Study group | Role | What they receive |
|---|---|---|
| Standard care + PTF DVD | Experimental | The intervention will include the standard care, with the addition of the PTF DVD. Participants randomized to this condition will receive Pathways to Freedom: Leading the Way to a Smoke-Free Community© (PTF). The content of the intervention parallels the types of education, advice, and cessation/relapse prevention strategies that are delivered in clinic and quitline contexts, except for the focus on the specific needs of the Black community. The 60- minute DVD consists of 7 sections. The cultural adaptations (e.g., focus on menthol, focus on religion/spirituality, Black images and music) were infused throughout the DVD. The PTF DVD is useable at varying levels along the readiness to quit smoking continuum, as viewers are empowered to view sections that match their interests and goals. Quit Coaches will be trained to refer participants to appropriate sections for additional help. Receives: Behavioral: Standard Care; Behavioral: PTF DVD |
| Standard care + standard smoking cessation DVD | Active comparator | This arm includes standard care, plus a standard smoking cessation DVD. The evidence-based "How to Quit" DVD contains 60 minutes of smoking cessation information and strategies. Narrated by a physician, it describes the process of quitting and strategies for increasing physical activity and healthy nutrition. It includes testimonials from former smokers and dialogue among smokers in a group counseling setting. The information is presented in a standard format, intended for the general population of smokers. Receives: Behavioral: Standard Care; Behavioral: smoking cessation DVD |
| Standard care only | Active comparator | Following the first counseling session, participants may receive up to 3 additional proactive counseling calls. Follow-up calls focus on challenges that may have occurred on the quit date or with the use of medication. Quit Coaches® review and modify the person's quit plan, and provide support as appropriate. Participants also receive standard self-help materials by mail, which is often referred to by Quit Coaches. For individuals who have successfully quit, the Coach will focus on relapse prevention strategies. Quit Coaches provide medication education to all participants eligible and interested in using cessation medications. This study will provide starter NRT kits (2 weeks supply) to all participants. Coaches provide decision support using a database-supported algorithm based on current scientific evidence and the product manufacturer use instructions for each drug. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cotinine-verified 7-day point-prevalence abstinence (ppa)
number of patients who self-report abstinence from tobacco at 6 months who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
Measured: At 6 months
Secondary outcomes (5)
Cotinine-verified 7-day ppa
number of patients at 3 months who self-report abstinence from tobacco for 7 days who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
Measured: At 3 months
Cotinine-verified 24-hour ppa
number of patients at 3 months who self-report abstinence from tobacco for 24 hours who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
Measured: At 3 months
Cotinine-verified 24-hour ppa
number of patients at 6 months who self-report abstinence from tobacco for 24 hours who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
Measured: At 6 months
28-day continuous abstinence
number of patients at 3 months who self-report abstinence from tobacco for 28 days who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
Measured: At 3 months
28-day continuous abstinence
number of patients at 6 months who self-report abstinence from tobacco for 28 days who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start22 May 2017
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Consumer Wellness Solutions, North Carolina Tobacco Quitline
- Responsible party
- Sponsor
- Investigators
- Monica Webb Hooper, PhD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064971
- Sponsor's protocol ID
- CASE8516
- Status last verified
- Aug 2020
- First submitted
- 22 Feb 2017
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Webb Hooper M, Carpenter KM, Salmon EE, Resnicow K. Enhancing Tobacco Quitline Outcomes for African American Adults: An RCT of a Culturally Specific Intervention. Am J Prev Med. 2023 Dec;65(6):964-972. doi: 10.1016/j.amepre.2023.06.005. Epub 2023 Jun 10.
PubMed 37302513Webb Hooper M, Carpenter K, Payne M, Resnicow K. Effects of a culturally specific tobacco cessation intervention among African American Quitline enrollees: a randomized controlled trial. BMC Public Health. 2018 Jan 10;18(1):123. doi: 10.1186/s12889-017-5015-z.
PubMed 29321008
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Quitline Services for African American Smokers: RCT of an Evidence-Based DVD
- ClinicalTrials.gov ID
- NCT03064971
- Acronym / sponsor ID
- CASE8516
- Conditions
- Tobacco Use Cessation
- Keywords
- Quitline, culturally specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Consumer Wellness Solutions, North Carolina Tobacco Quitline
- Study start
- 22 May 2017 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 27 Feb 2017 (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 study proposes to test the value of a culturally specific program for African American smokers to quit smoking.
Detailed description
The intervention to be tested, Pathways to Freedom (PTF), is a video-based program that will be examined as an adjunct to tobacco cessation services provided through a state quitline. Investigators will conduct a 3-arm randomized controlled trial (RCT) to obtain real-world evidence for the efficacy of the PTF DVD. Participants will be randomly assigned to receive standard care plus PTF DVD, standard care plus standard smoking cessation DVD, or standard care only; assessments will occur at baseline, 3, and 6 months post-enrollment. All participants will receive nicotine replacement therapy (NRT). Thus, the impact of the PTF DVD will be isolated, informing investigators whether standard telephone counseling can be enhanced by the provision of a culturally specific DVD-based intervention. The primary abstinence outcome will be cotinine-verified 7-day point-prevalence abstinence (ppa) at the 6-month follow-up; secondary outcomes will be 7-day ppa at 3-months, 24-hour ppa, and 28-day continuous abstinence.
Objective 1: To test the efficacy of an innovative evidence-based smoking cessation DVD targeting African American smokers. Investigators will conduct a 3-arm randomized controlled trial (RCT) to obtain real-world evidence for the efficacy of the Pathway to Freedom (PTF) DVD. Participants will be randomly assigned to receive standard care plus PTF DVD, standard care plus standard smoking cessation DVD, or standard care only; assessments will occur at baseline, 3, and 6 months post-enrollment. All participants will receive nicotine replacement therapy (NRT). Thus, the impact of the PTF DVD will be isolated, informing us of whether standard telephone counseling can be enhanced by the provision of a culturally specific DVD-based intervention. The primary abstinence outcome will be cotinine-verified 7-day point-prevalence abstinence (ppa) at the 6-month follow-up; secondary outcomes will be 7-day ppa at 3-months, 24-hour ppa, and 28-day continuous abstinence. Controlling for covariates (any group differences in socio-demographics, smoking history, and NRT use), the study hypothesizes that standard care plus the PTF DVD will produce greater abstinence rates compared to standard care plus a standard cessation DVD. In this study, it is also expect that the greater abstinence rates in the PTF DVD condition will be maintained over time.
Objective 2: To examine the effect of the PTF DVD on treatment engagement. Previous research suggests that culturally specific interventions are preferred by African American smokers compared to standard interventions. This preference may impact engagement in treatment, which would also represent an important indicator of success. Controlling for baseline differences, this study hypothesizes that the PTF DVD will lead to greater engagement in treatment, specifically positive evaluations of the telephone counseling and smoking cessation DVDs, session length, completed counseling sessions, DVD viewing, NRT use, use of coping strategies, and study retention compared to the standard DVD control group.
Objective 3 (exploratory): To assess the feasibility of delivering the PTF DVD in an online format. Although there are several indications that a DVD format is cutting edge for African American smokers, who tend to be of lower socioeconomic status and have less Internet access, the study will assess the acceptability and utilization of delivering the video interventions in an online format. Specifically, at the 3 and 6-month follow-ups, participants will rate their satisfaction and experience with accessing the videos in each condition via a private YouTube channel, and report the frequency of online viewing. As this is an exploratory aim, there is no specific hypotheses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard care + PTF DVD | Experimental | Behavioral: Standard Care, Behavioral: PTF DVDThe intervention will include the standard care, with the addition of the PTF DVD. Participants randomized to this condition will receive Pathways to Freedom: Leading the Way to a Smoke-Free Community© (PTF). The content of the intervention parallels the types of education, advice, and cessation/relapse prevention strategies that are delivered in clinic and quitline contexts, except for the focus on the specific needs of the Black community. The 60- minute DVD consists of 7 sections. The cultural adaptations (e.g., focus on menthol, focus on religion/spirituality, Black images and music) were infused throughout the DVD. The PTF DVD is useable at varying levels along the readiness to quit smoking continuum, as viewers are empowered to view sections that match their interests and goals. Quit Coaches will be trained to refer participants to appropriate sections for additional help. |
| Standard care + standard smoking cessation DVD | Active comparator | Behavioral: Standard Care, Behavioral: smoking cessation DVDThis arm includes standard care, plus a standard smoking cessation DVD. The evidence-based "How to Quit" DVD contains 60 minutes of smoking cessation information and strategies. Narrated by a physician, it describes the process of quitting and strategies for increasing physical activity and healthy nutrition. It includes testimonials from former smokers and dialogue among smokers in a group counseling setting. The information is presented in a standard format, intended for the general population of smokers. |
| Standard care only | Active comparator | Behavioral: Standard CareFollowing the first counseling session, participants may receive up to 3 additional proactive counseling calls. Follow-up calls focus on challenges that may have occurred on the quit date or with the use of medication. Quit Coaches® review and modify the person's quit plan, and provide support as appropriate. Participants also receive standard self-help materials by mail, which is often referred to by Quit Coaches. For individuals who have successfully quit, the Coach will focus on relapse prevention strategies. Quit Coaches provide medication education to all participants eligible and interested in using cessation medications. This study will provide starter NRT kits (2 weeks supply) to all participants. Coaches provide decision support using a database-supported algorithm based on current scientific evidence and the product manufacturer use instructions for each drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identification as Black/African American
- Current smokers (smoked at least 100 lifetime cigarettes and currently smoke on some or every day) who would like help quitting
- Eligible for state quitline services
- Access to devices that play DVDs
- Permanent contact information
Key exclusion criteria (2 listed)
- Recent quitters (have not smoked in past 7 days)
- Medical contraindications for nicotine replacement therapy (NRT)
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 |
|---|---|---|
| Standard CareStandard of care provided by QuitlineNC includes Quit Coaches, counseling calls, nicotine replacement therapy, and written materials | Behavioural | Standard care + PTF DVD, Standard care + standard smoking cessation DVD, Standard care only |
| smoking cessation DVDThe evidence-based "How to Quit" DVD contains 60 minutes of smoking cessation information and strategies | Behavioural | Standard care + standard smoking cessation DVD |
| PTF DVDAlso: Pathways to Freedom DVDCulturally specific smoking cessation DVD. This DVD contains 60 minutes of material. | Behavioural | Standard care + PTF DVD |
Primary outcome
Cotinine-verified 7-day point-prevalence abstinence (ppa)
Time frame: At 6 months
number of patients who self-report abstinence from tobacco at 6 months who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
5 secondary outcomes
Cotinine-verified 7-day ppa
Time frame: At 3 months
Cotinine-verified 24-hour ppa
Time frame: At 3 months
Cotinine-verified 24-hour ppa
Time frame: At 6 months
28-day continuous abstinence
Time frame: At 3 months
28-day continuous abstinence
Time frame: At 6 months
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 19 Aug 2020.
- Derived from this study: PubMed 37302513Webb Hooper M, Carpenter KM, Salmon EE, Resnicow K. Enhancing Tobacco Quitline Outcomes for African American Adults: An RCT of a Culturally Specific Intervention. Am J Prev Med. 2023 Dec;65(6):964-972. doi: 10.1016/j.amepre.2023.06.005. Epub 2023 Jun 10.
- Derived from this study: PubMed 29321008Webb Hooper M, Carpenter K, Payne M, Resnicow K. Effects of a culturally specific tobacco cessation intervention among African American Quitline enrollees: a randomized controlled trial. BMC Public Health. 2018 Jan 10;18(1):123. doi: 10.1186/s12889-017-5015-z.
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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.
Monica Webb Hooper, PhD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoking cessation DVD and PTF DVD in people with Tobacco Use Cessation, run by Case Comprehensive Cancer Center at 1 site in United States.
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 5 inclusion and 2 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Cotinine-verified 7-day point-prevalence abstinence (ppa) (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064971, which also lists 2 linked publications.
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 19 Aug 2020.