Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients
|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|
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* To assess the feasibility of delivering a Quitline based smoking cessation intervention to cancer patients in an outpatient setting. To achieve this, we will deliver the intervention to cancer patients in the surgery, radiation and medical oncology departments of participating Community Clinical Oncology Program (CCOP) sites. Following the intervention, we will assess participant, CRA (Clinical Research Associate) Counselor and Quitline staff ratings of acceptability, resources required to deliver the intervention, protocol fidelity, and participant recruitment, retention and adherence.
- To obtain a preliminary estimate of the quit rate (as defined by 7-day point-prevalence abstinence) in intervention and control groups. To accomplish this aim, following the intervention we will collect confirmed smoking status data for intervention and control subjects. We will also obtain a preliminary estimate of the treatment effect (difference in quit rates between the two groups) and the standard deviation to better determine the sample size for a future trial.
- To evaluate primary patient reported outcomes, including quality of life (quantified by the FACT-G and for lung cancer patients only the FACT-L other concerns questions and the EORTC QLQ LC13), perceived life stress (quantified by the Perceived Stress Scale), and depression (quantified by the CESD-10), in cancer patients in the intervention and control groups.
- To refine the recruitment and intervention protocols using data collected from participants, Clinical Research Associate (CRA) Counselor, and Quitline staff to increase acceptability and improve retention in future trials.
OUTLINE: This is a multicenter study. Participants are stratified according to time since diagnosis (< 3 months vs ≥ 3 months), treatment status (ongoing vs completed), and cigarette smoking (≤ 10 per day vs ≥ 11 per day). Patients are randomized to 1 of 2 intervention arms.
- Arm I (intervention): 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. During the counseling session, participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues such as managing the stressors associated with cancer diagnosis and treatment. They are also told to expect a call from the Quitline in 2-3 days and receive a fact sheet about benefits of smoking cessation for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Calls are scheduled at convenient times for the participants and at relapse-sensitive intervals including; an initial planning and assessment call, a quit date call, a follow-up call 7 days after the participant's quit date, and 2 additional calls at 2-3-week intervals. Participants are also encouraged to utilize the Quit for Life Web Coach, an interactive web program application that guides them to build online quit plans, set quit dates, and track their progress toward quitting. Participants also learn behavioral tips and coping skills by interacting with others in topic-based discussion forums and community support programs.
- Arm II (standard of 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.
Participants on the intervention arm complete the Smoking Assessment, Smoking Cessation Self-Efficacy, the Brief Smoking Consequences, the Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire LC-13, the Perceived Stress Scale, the Center for Epidemiologic Studies Short Depression Scale (CESD-10 Depression), and the Follow up Smoking Assessment questionnaires at baseline and at 6, 12, and 24 weeks.
Participants, on the intervention arm, undergo saliva sample collection at baseline and at 12 and 24 weeks for cotinine level analysis.
|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|