Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients
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.
Tobacco Use Disorder
Drug: Nicotine Replacement Patch
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Lung Cancer Patients Receiving Outpatient Treatment: A Pilot Study|
- Evaluate a smoking cessation intervention among cancer patients [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]Evaluate a smoking cessation intervention among cancer patients who are scheduled to receive or currently receiving surgery, radiation or chemotherapy OR have received one or more of the following within the last 6 months surgery, last radiation treatment, or last chemotherapy treatment in a community outpatient setting.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I - Nicotine Replacement Patch
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
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01434342
|Contact: Robin Rosdhal, RN||(336) firstname.lastname@example.org|
|United States, North Carolina|
|W F Baptist Health||Recruiting|
|Winston Salem, North Carolina, United States, 27157|
|Contact: robin rosdhal, RN 336-713-6519|
|Principal Investigator:||Kathryn Weaver, PhD, MPH||Comprehensive Cancer Center of Wake Forest University|