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Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients

NCT01434342 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2021-09-28

Study results available
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Summary

RATIONALE: Continued smoking after a cancer diagnosis has important health consequences beyond the risks associated with smoking in the general population. Smoking reduces the efficacy of cancer treatments including surgery, radiation and chemotherapy. Despite the negative consequences, it is estimated that between 15-75% of patients with cancer continue to smoke after their cancer diagnosis. Lung, breast, prostate, colorectal, bladder, head \& neck, and cervical cancer patients were chosen because there is evidence of potential clinical benefit associated with quitting smoking in all of these populations and they represent a mix of both smoking and non-smoking related cancers.

Conditions

Interventions

DRUG

Nicotine Replacement Patch

Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 weeks after the date of the in-person intervention (for Quitline Intervention group) or the provision of the physician letter (for the Usual Care Plus group).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Kathryn Weaver, PhD, MPH · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-01
Primary Completion
2014-06-01
Completion
2015-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01434342 on ClinicalTrials.gov