NCT00379054

Brief 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. Both interventions provide information on how support persons can encourage a smoker to quit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 22, 2010

Status Verified

November 1, 2010

Enrollment Period

1.7 years

First QC Date

September 19, 2006

Last Update Submit

November 18, 2010

Conditions

Smoking Cessation

Keywords

social support, smoking, smoking cessation, intervention,telephone counseling

Outcome Measures

Primary Outcomes (5)

  • 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.

Interventions

telephone based skills training interventionBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Smoking CessationSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Christi A Patten, Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 21, 2006

Study Start

September 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

November 22, 2010

Record last verified: 2010-11

Locations

US(1)