{"description":"Sample size is the number of participants with follow-up toxicity data","eventGroups":[{"description":"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.\n\nNicotine 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 we","id":"EG000","otherNumAffected":61,"otherNumAtRisk":75,"seriousNumAffected":14,"seriousNumAtRisk":75,"title":"Arm I - Quitline"},{"description":"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.","id":"EG001","otherNumAffected":33,"otherNumAtRisk":37,"seriousNumAffected":5,"seriousNumAtRisk":37,"title":"Arm II - Usual Care"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":75,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":37,"numEvents":3}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":75,"numEvents":74},{"groupId":"EG001","numAffected":15,"numAtRisk":37,"numEvents":27}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":75,"numEvents":9},{"groupId":"EG001","numAffected":3,"numAtRisk":37,"numEvents":4}],"term":"Chest pain cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":75,"numEvents":41},{"groupId":"EG001","numAffected":9,"numAtRisk":37,"numEvents":16}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":75,"numEvents":15},{"groupId":"EG001","numAffected":5,"numAtRisk":37,"numEvents":9}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":75,"numEvents":56},{"groupId":"EG001","numAffected":14,"numAtRisk":37,"numEvents":27}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":75,"numEvents":18},{"groupId":"EG001","numAffected":3,"numAtRisk":37,"numEvents":3}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":75,"numEvents":34},{"groupId":"EG001","numAffected":9,"numAtRisk":37,"numEvents":17}],"term":"Dry Mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":75,"numEvents":30},{"groupId":"EG001","numAffected":7,"numAtRisk":37,"numEvents":10}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":75,"numEvents":93},{"groupId":"EG001","numAffected":15,"numAtRisk":37,"numEvents":27}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":75,"numEvents":30},{"groupId":"EG001","numAffected":7,"numAtRisk":37,"numEvents":14}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":75,"numEvents":41},{"groupId":"EG001","numAffected":6,"numAtRisk":37,"numEvents":8}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":75,"numEvents":58},{"groupId":"EG001","numAffected":11,"numAtRisk":37,"numEvents":19}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Musculoskeletal and connective tissue disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":75,"numEvents":48},{"groupId":"EG001","numAffected":13,"numAtRisk":37,"numEvents":28}],"term":"Myalagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":75,"numEvents":41},{"groupId":"EG001","numAffected":3,"numAtRisk":37,"numEvents":5}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":37,"numEvents":2}],"term":"Nervous system disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":75,"numEvents":16},{"groupId":"EG001","numAffected":4,"numAtRisk":37,"numEvents":9}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":37,"numEvents":6}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":75,"numEvents":17},{"groupId":"EG001","numAffected":4,"numAtRisk":37,"numEvents":4}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":75,"numEvents":9},{"groupId":"EG001","numAffected":3,"numAtRisk":37,"numEvents":5}],"term":"Psychiatric disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":75,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":37,"numEvents":2}],"term":"Rash masculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":75,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":37,"numEvents":3}],"term":"Skin and subcutaneous tissue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":37,"numEvents":2}],"term":"Sore Throat"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":75,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Bladder Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":75,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":37,"numEvents":1}],"term":"Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Dry Mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":75,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":37,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":75,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":37,"numEvents":1}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Generalized Muscle Weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":75,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":37,"numEvents":1}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Mucosal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Mucositis Oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Musculoskeletal and connective tissue disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Neutrophil Count"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Skin and subcutaneous tissue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":75,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":37,"numEvents":0}],"term":"Wound infection"}],"timeFrame":"24 weeks"}