Smoking CessationPhase 1/2NCT00379054
Intervention for Support Persons to Help Smokers Quit
A Phase 1/2 study testing telephone based skills training intervention in people with Smoking Cessation, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will examine the feasibility and potential effectiveness of an intervention for adults who want to help support a smoker to quit. The support persons will receive either self-help materials only or the self-help materials plus a telephone counseling intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- telephone based skills training intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2007
- Phase
- Phase 1/2
- 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
- To be eligible, the support person must (1) be 18 years of age or older, (2) provide written informed consent, (3) be a never or former cigarette smoker (no cigarette use during the past 6 months), (4) be interested in helping someone 18 years of age who is a current smoker (average of 10 cigarettes per day in the past 7 days), (5) be able and willing to participate in all aspects of the study, (6) have current and anticipated contact (any combination of face-to-face, telephone, or electronic mail) with the smoker a total of at least 4 days of the week for the study duration, and (7), the smoker provides informed consent for the support person's involvement in the study.
- -
Who cannot join
- another support person from the same household has enrolled, (2) another support person has enrolled to help the same smoker, or (3) the smoker is currently (past 30 days) receiving pharmacologic or behavioral treatment for nicotine dependence.
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine the feasibility and potential effectiveness of an intervention for adults who want to help support a smoker to quit. The support persons will receive either self-help materials only or the self-help materials plus a telephone counseling intervention. Both interventions provide information on how support persons can encourage a smoker to quit.
Read the detailed description
Interventions that reach the majority of cigarette smokers in the population have the greatest potential to impact the public health. Most smokers do not seek treatment for smoking cessation. A novel behavioral approach to reaching smokers is to directly recruit and train adult nonsmokers to intervene (i.e., support persons). Several studies provide evidence for the role of social support in smoking cessation. The use of support persons as change agents for smoking cessation represents a shift from conventional interventions that focus almost exclusively on the smoker. This proposal builds on our previous work that indicates a skills training intervention for support persons is feasible and acceptable to participants. Moreover, the effect size observed for the smoking abstinence rate in the smokers, as reported by the support persons, provides some evidence of potential efficacy. However, the intensive, group, clinic-based format of the intervention limits its potential dissemination. We propose to develop and pilot test a more streamlined version of the intervention using a telephone-based format. To enhance internal validity of the findings, additional formative work is also needed to examine the feasibility of obtaining baseline assessments and outcomes directly from the smoker. Social cognitive theory is the conceptual basis for the proposed intervention.
The objective of this R21 proposal is to develop and pilot test a novel behavioral approach to smoking cessation that utilizes support persons in the smoker's natural environment. We expect that as a result of this project, we will have developed a well-specified and feasible telephone counseling intervention, the efficacy of which can be tested in future larger-scale randomized clinical trials.
This project will take place in two phases. In Phase 1, we will develop a telephone counseling intervention for support persons, adapting and refining the intervention from our previous, clinic-based treatment study. During this phase, we will develop the telephone counselor manual, and 10 support persons will complete the protocol, which will be modified and refined based on feedback from participants and counselors. Phase 2, consisting of a pilot clinical trial, will apply a randomized, two group design with repeated assessments at weeks 0 (baseline), 10 (end-of-treatment), and 26. Support persons (N=60) will be recruited and randomly assigned to self-help intervention or telephone counseling. The smokers will be enrolled as study subjects but will be contacted for assessments only.
- Conditions
- Smoking Cessation
- Being tested
- telephone based skills training intervention
- Keywords
- social support, smoking, smoking cessation, intervention,, telephone counseling
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone based skills training interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (recruitment and retention of support persons and smokers),
acceptability of intervention to support persons, potential efficacy
(determined by number of smoker quit attempts, smoking abstinence, readiness
to quit)and changes in supportive behaviors among the support persons as
measured by the Support Provided Measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startSep 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Christi A Patten, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379054
- Sponsor's protocol ID
- 1928-04
- Other IDs
- 5R21DA018365-02, 1R21DA018365-01
- Status last verified
- Nov 2010
- First submitted
- 19 Sep 2006
- Last updated
- 22 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Support Persons to Help Smokers Quit
- ClinicalTrials.gov ID
- NCT00379054
- Acronym / sponsor ID
- 1928-04
- Conditions
- Smoking Cessation
- Keywords
- social support, smoking, smoking cessation, intervention,, telephone counseling
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 21 Sep 2006 (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.
This study will examine the feasibility and potential effectiveness of an intervention for adults who want to help support a smoker to quit. The support persons will receive either self-help materials only or the self-help materials plus a telephone counseling intervention. Both interventions provide information on how support persons can encourage a smoker to quit.
Detailed description
Interventions that reach the majority of cigarette smokers in the population have the greatest potential to impact the public health. Most smokers do not seek treatment for smoking cessation. A novel behavioral approach to reaching smokers is to directly recruit and train adult nonsmokers to intervene (i.e., support persons). Several studies provide evidence for the role of social support in smoking cessation. The use of support persons as change agents for smoking cessation represents a shift from conventional interventions that focus almost exclusively on the smoker. This proposal builds on our previous work that indicates a skills training intervention for support persons is feasible and acceptable to participants. Moreover, the effect size observed for the smoking abstinence rate in the smokers, as reported by the support persons, provides some evidence of potential efficacy. However, the intensive, group, clinic-based format of the intervention limits its potential dissemination. We propose to develop and pilot test a more streamlined version of the intervention using a telephone-based format. To enhance internal validity of the findings, additional formative work is also needed to examine the feasibility of obtaining baseline assessments and outcomes directly from the smoker. Social cognitive theory is the conceptual basis for the proposed intervention.
The objective of this R21 proposal is to develop and pilot test a novel behavioral approach to smoking cessation that utilizes support persons in the smoker's natural environment. We expect that as a result of this project, we will have developed a well-specified and feasible telephone counseling intervention, the efficacy of which can be tested in future larger-scale randomized clinical trials.
This project will take place in two phases. In Phase 1, we will develop a telephone counseling intervention for support persons, adapting and refining the intervention from our previous, clinic-based treatment study. During this phase, we will develop the telephone counselor manual, and 10 support persons will complete the protocol, which will be modified and refined based on feedback from participants and counselors. Phase 2, consisting of a pilot clinical trial, will apply a randomized, two group design with repeated assessments at weeks 0 (baseline), 10 (end-of-treatment), and 26. Support persons (N=60) will be recruited and randomly assigned to self-help intervention or telephone counseling. The smokers will be enrolled as study subjects but will be contacted for assessments only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be eligible, the support person must (1) be 18 years of age or older, (2) provide written informed consent, (3) be a never or former cigarette smoker (no cigarette use during the past 6 months), (4) be interested in helping someone 18 years of age who is a current smoker (average of 10 cigarettes per day in the past 7 days), (5) be able and willing to participate in all aspects of the study, (6) have current and anticipated contact (any combination of face-to-face, telephone, or electronic mail) with the smoker a total of at least 4 days of the week for the study duration, and (7), the smoker provides informed consent for the support person's involvement in the study.
- -
Key exclusion criteria (2 listed)
- another support person from the same household has enrolled, (2) another support person has enrolled to help the same smoker, or (3) the smoker is currently (past 30 days) receiving pharmacologic or behavioral treatment for nicotine dependence.
- -
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 |
|---|---|---|
| telephone based skills training intervention | Behavioural | – |
Primary outcome
Feasibility (recruitment and retention of support persons and smokers),
acceptability of intervention to support persons, potential efficacy
(determined by number of smoker quit attempts, smoking abstinence, readiness
to quit)and changes in supportive behaviors among the support persons as
measured by the Support Provided Measure.
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 22 Nov 2010.
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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.
Christi A Patten, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing telephone based skills training intervention in people with Smoking Cessation, run by Mayo Clinic 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 2 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 22 Nov 2010. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility (recruitment and retention of support persons and smokers),. The study lists 5 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 22 Nov 2010.