Intervention for Support Persons to Help Smokers Quit

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00379054
First received: September 19, 2006
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Behavioral: telephone based skills training intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intervention for Support Persons to Help Smokers Quit

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 70
Study Start Date: September 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

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Exclusion Criteria:

(1) 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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379054

Locations
United States, Minnesota
Mayo
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Christi A Patten, Ph.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00379054     History of Changes
Other Study ID Numbers: 1928-04, 5R21DA018365-02, 1R21DA018365-01
Study First Received: September 19, 2006
Last Updated: November 18, 2010
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
social support, smoking, smoking cessation, intervention,
telephone counseling

ClinicalTrials.gov processed this record on September 16, 2014