Smoking Cessation Intervention for Cancer Patients
|ClinicalTrials.gov Identifier: NCT00575718|
Recruitment Status : Active, not recruiting
First Posted : December 18, 2007
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Newly Diagnosed Cancer Patients||Behavioral: Hospital Counseling + Nicotine Replacement Therapy. questionaires Behavioral: Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionaires||Not Applicable|
Smoking cessation offers an important way for newly diagnosed cancer patients to take an active role in their treatment and recovery. Quitting tobacco use decreases cancer patients' risk of disease recurrence and development of second primary cancers. In addition, preoperative tobacco cessation may reduce the likelihood of perioperative pulmonary, cardiovascular, and wound healing complications. Due to increased awareness of the health hazards of tobacco use, rates of cessation after cancer diagnosis are high. However, 35% to 69% of patients continue to use tobacco and this is largely due to strong barriers to quitting (low-self efficacy, psychological distress) rather than lack of positive intentions to quit. Previous attempts to increase smoking cessation among the medically ill have provided intervention either during or after hospitalization.
We propose that the period immediately prior to hospitalization and surgery represents a unique window of opportunity, or "teachable moment," for smoking cessation that could take full advantage of patients' enhanced health awareness and quitting motivation, strong physician quitting advice, and patients' heightened desire to take an active role in their care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Presurgical Smoking Cessation Intervention for Cancer Patients: The Resolve Study|
|Study Start Date :||October 2002|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Active Comparator: 1
Hospital Counseling + Nicotine Replacement Therapy (HC+NRT)
Behavioral: Hospital Counseling + Nicotine Replacement Therapy. questionaires
brief face-to-face or telephone tobacco cessation counseling provided by a tobacco cessation specialist prior to admission and during hospitalization (15-20 minutes per encounter)provision of multi-media self-help materials (e.g., "Smoking Cessation Guide for Cancer Patients and Their Families") tailored to address cancer-specific issues such as the benefits and barriers of quitting for cancer patients; 3) tobacco cessation pharmacotherapy, unless medically contraindicated (for this study we will standardize the pharmacotherapy as transdermal nicotine patch), and; 4) two brief telephone counseling (15 minutes) sessions completed as seen clinically appropriate by the tobacco cessation specialists. The content of these counseling sessions is based on the patient's smoking status.
Hospital Counseling + Nicotine Replacement Therapy + Pre-surgical Schedule Reduced Smoking (HC+NRT+PS/SRS)
Behavioral: Hospital Counseling + Nicotine Replacement + Presurgical Scheduled Reduced Smoking, questionaires
Same components of HC+NRT as well as the PS/SRS enhancement.The research team will provide education about scheduled reduced smoking either in person or over the phone. Purpose of the training session, will be audio taped, to prepare participants for daily PDA use over the dur of the scheduled-reduced smoking intervention. Training will demonstrate use of PDA and simulate common technical and procedural issues that might arise during the intervention (e.g., forgetting to record a cigarette or wake time; repeating a day's schedule if needed, prior to the quit date). The simulation will reflect anticipated problems and those identified by users of the PDA. A study helpline number and instructional manual will be provided. A member of the research staff will contact the study participants, once the reduced smoking schedule has begun, to check that the patient understands the schedule and that the PDA is working properly. Estimate patient training with the PDA will require 30 minutes.
- efficacy of a presurgical smoking cessation intervention that adds scheduled reduced smoking, a highly effective behavioral treatment in non-medically ill tobacco users, to enhanced usual care, i.e., hospital counseling and nicotine replacement therapy. [ Time Frame: will be measured at hospital admission, and 3 and 6 months post-hospital admission. ]
- whether addition of a presurgical scheduled reduced smoking intervention improves smoking cessation and long-term abstinence rates c/w hospital counseling and nicotine transdermal patch (enhanced usual care) for recently diagnosed cancer patients. [ Time Frame: 6-8 months ]
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): NCT00575718
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Jamie Ostroff, PhD||Memorial Sloan Kettering Cancer Center|