Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01434342|
Recruitment Status : Completed
First Posted : September 14, 2011
Results First Posted : June 6, 2017
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Tobacco Use Disorder Breast Cancer Colorectal Cancer Prostate Cancer||Drug: Nicotine Replacement Patch||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Lung Cancer Patients Receiving Outpatient Treatment: A Pilot Study|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||January 2015|
Experimental: Arm I - Quitline
Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.
The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.
Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.
Participants also learn behavioral tips and coping skills.
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).
No Intervention: Arm II - Usual Care
Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
- Feasibility of a Smoking Cessation Intervention Among Cancer Patients [ Time Frame: 24 Weeks ]The primary feasibility measures are retention and adherence. This outcome, retention, is the percentage of patient who remain in the study for 24 weeks.
- Adherence [ Time Frame: 24 weeks ]Adherence is measured by the percentage of randomized participants who have a Quitline call. Note that this outcome is only defined for the Intervention arm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434342
|United States, North Carolina|
|W F Baptist Health|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Kathryn Weaver, PhD, MPH||Wake Forest University Health Sciences|