NCT02211196

Brief Summary

This pilot clinical trial studies evidence-based tobacco cessation strategies in patients with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit smoking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
377

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

August 5, 2014

Last Update Submit

July 2, 2018

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (6)

  • Percentage of providers from the Piedmont Oncology Association (POA) reporting a need for training on evidence-based tobacco cessation strategies

    Will be estimated and 95% confidence intervals (CI) constructed.

    Up to 1 month

  • Percentage reporting feeling very confident in their ability to counsel smokers

    Will be estimated and 95% CI constructed.

    Up to 1 month

  • Percentage reporting they would be willing to participate in training on evidence-based tobacco cessation strategies

    Will be estimated and 95% CI constructed.

    Up to 1 month

  • Proportion of oncology patients willing to complete a survey in an oncology clinic

    Will be estimated and 95% CI constructed.

    Up to 1 month

  • Proportion of patients who report that their provider asked about tobacco use during their visit

    These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.

    Up to 1 month

  • Proportion of current smokers who report that their provider advised them to quit during their visit and provided tobacco-cessation strategies

    These prevalences will be estimated at pre- and post-intervention, and 95% CIs calculated adjusting for the expected within-clinic correlation of patient outcomes. These outcomes will be analyzed further using a subject-specific modeling approach to account for the correlation that occurs due to patients being clustered within clinics.

    Up to 1 month

Study Arms (1)

Health Services Research (smoking cessation intervention)

EXPERIMENTAL

Participants complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting.

Behavioral: smoking cessation interventionOther: survey administrationOther: questionnaire administration

Interventions

smoking cessation interventionBEHAVIORAL

Receive evidence-based tobacco cessation strategies

Health Services Research (smoking cessation intervention)
survey administrationOTHER

Ancillary studies

Health Services Research (smoking cessation intervention)
questionnaire administrationOTHER

Ancillary studies

Health Services Research (smoking cessation intervention)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with cancer who saw a provider will be eligible

You may not qualify if:

  • Having a nurse or lab visit only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Erin Sutfin

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 7, 2014

Study Start

February 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 3, 2018

Record last verified: 2018-07

Locations

US(1)