Tobacco Use CessationNCT01885221
A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation (UCare-ChewFree)
A study testing Multimedia Support Intervention in people with Tobacco Use Cessation, run by Oregon Research Institute at 1 site in United States.
Trial summary
In an earlier study, the investigators developed a guidebook that taught women supportive behaviors to help their husbands/partners quit smokeless tobacco. This study will create a website using the information in the guidebook, along with interactive features, videos, and forums. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Multimedia Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2012to 31 Aug 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being the wife or female domestic partner (living together) of a male who is a current user of ST products (snuff or chewing tobacco)
- interested in having him quit ST use
- willing to provide a phone number, mailing address, and e-mail address
- provides informed consent
- the woman and the chewer are both U.S. or Canadian residents age 18 or older
- the woman and the chewer are both able to read English
- the woman and the chewer are both able to access a computer
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation
In an earlier study, the investigators developed a guidebook that taught women supportive behaviors to help their husbands/partners quit smokeless tobacco. This study will create a website using the information in the guidebook, along with interactive features, videos, and forums. The investigators will then conduct a randomized trial comparing an intervention group (receiving website access and the printed guidebook) with a delayed treatment control condition, to learn if the support intervention can effectively teach women supportive behaviors and thereby increase their partners' smokeless tobacco cessation rates.
- Conditions
- Tobacco Use Cessation
- Being tested
- Multimedia Support Intervention
- Keywords
- smokeless tobacco cessation, social support, partner support
- 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.
Multimedia Support InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Multimedia Support Intervention | Experimental | (a) access to a website providing the content of our supporter guidebook, supplemented with interactive components, video elements, and a supporters' forum, and (b) a mailed copy of our supporter guidebook Receives: Behavioral: Multimedia Support Intervention |
| Delayed Treatment Control | No intervention | Access to the Multimedia Intervention after participant completes the final follow-up assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
smokeless tobacco cessation
the male ST user's 6-month cessation as reported by the female partner
Measured: 7.5-month follow-up
Secondary outcomes (2)
tobacco quit attempts
the male smokeless tobacco user's quit attempts, as reported by the female partner
Measured: 7.5 month follow-up
supportive behaviors
change in the female partner's supportive behaviors
Measured: 7.5 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study start1 Sep 2012
- Primary completion30 Jun 2016
- Study completion31 Aug 2018
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura E Akers, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885221
- Sponsor's protocol ID
- DA033422
- Status last verified
- Sep 2018
- First submitted
- 20 Jun 2013
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Akers L, Andrews JA, Lichtenstein E, Severson HH, Gordon JS. Effect of a Responsiveness-Based Support Intervention on Smokeless Tobacco Cessation: The UCare-ChewFree Randomized Clinical Trial. Nicotine Tob Res. 2020 Mar 16;22(3):381-389. doi: 10.1093/ntr/ntz074.
PubMed 31070741Akers L, Andrews JA, Gordon JS. A Multimedia Support Skills Intervention for Female Partners of Male Smokeless Tobacco Users: Use and Perceived Acceptability. JMIR Form Res. 2018 Jan-Jun;2(1):e10. doi: 10.2196/formative.9948.
PubMed 30556053
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation
- ClinicalTrials.gov ID
- NCT01885221
- Acronym / sponsor ID
- DA033422
- Conditions
- Tobacco Use Cessation
- Keywords
- smokeless tobacco cessation, social support, partner support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 24 Jun 2013 (estimated)
- 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.
In an earlier study, the investigators developed a guidebook that taught women supportive behaviors to help their husbands/partners quit smokeless tobacco. This study will create a website using the information in the guidebook, along with interactive features, videos, and forums. The investigators will then conduct a randomized trial comparing an intervention group (receiving website access and the printed guidebook) with a delayed treatment control condition, to learn if the support intervention can effectively teach women supportive behaviors and thereby increase their partners' smokeless tobacco cessation rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimedia Support Intervention | Experimental | Behavioral: Multimedia Support Intervention(a) access to a website providing the content of our supporter guidebook, supplemented with interactive components, video elements, and a supporters' forum, and (b) a mailed copy of our supporter guidebook |
| Delayed Treatment Control | No intervention | –Access to the Multimedia Intervention after participant completes the final follow-up assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- being the wife or female domestic partner (living together) of a male who is a current user of ST products (snuff or chewing tobacco)
- interested in having him quit ST use
- willing to provide a phone number, mailing address, and e-mail address
- provides informed consent
- the woman and the chewer are both U.S. or Canadian residents age 18 or older
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Multimedia Support Intervention | Behavioural | Multimedia Support Intervention |
Primary outcome
smokeless tobacco cessation
Time frame: 7.5-month follow-up
the male ST user's 6-month cessation as reported by the female partner
2 secondary outcomes
tobacco quit attempts
Time frame: 7.5 month follow-up
supportive behaviors
Time frame: 7.5 month follow-up
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 21 Sep 2018.
- Derived from this study: PubMed 31070741Akers L, Andrews JA, Lichtenstein E, Severson HH, Gordon JS. Effect of a Responsiveness-Based Support Intervention on Smokeless Tobacco Cessation: The UCare-ChewFree Randomized Clinical Trial. Nicotine Tob Res. 2020 Mar 16;22(3):381-389. doi: 10.1093/ntr/ntz074.
- Derived from this study: PubMed 30556053Akers L, Andrews JA, Gordon JS. A Multimedia Support Skills Intervention for Female Partners of Male Smokeless Tobacco Users: Use and Perceived Acceptability. JMIR Form Res. 2018 Jan-Jun;2(1):e10. doi: 10.2196/formative.9948.
Related trials for Tobacco Use Cessation
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
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.
Laura E Akers, Ph.D. principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia Support Intervention in people with Tobacco Use Cessation, run by Oregon Research Institute 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 7 inclusion and 1 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 21 Sep 2018. 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?
smokeless tobacco cessation (time frame: 7.5-month follow-up). 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 NCT01885221, 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 21 Sep 2018.