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Cognitive and Behavioral Therapy or Standard Care in Patients With Advanced Gastrointestinal Cancer or Lung Cancer - NCT00706290-02114(Clinical Trial 229176)



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City:  Boston
State:  
MA
Zip Code: 02114
Conditions: Anxiety Disorder - Colorectal Cancer - Depression - Esophageal Cancer - Extrahepatic Bile Duct Cancer - Gallbladder Cancer - Gastric Cancer - Liver Cancer - Lung Cancer - Pancreatic Cancer - Psychosocial Effects of Cancer and Its Treatment
Purpose: RATIONALE: Providing cognitive and behavioral therapy may improve the well-being and quality of life of patients with advanced cancer. PURPOSE: This randomized clinical trial is studying cognitive and behavioral therapy to see how well it works compared with standard care in treating patients with advanced gastrointestinal cancer or lung cancer.
Study summary: OBJECTIVES: - To develop and examine the feasibility and patient acceptability of administering a manualized cognitive-behavioral intervention that improves quality of life by treating anxiety in patients with advanced gastrointestinal cancer or lung cancer. - To estimate the effect size of a manualized cognitive-behavioral intervention to reduce anxiety in patients with advanced lung or gastrointestinal cancer. - To estimate the effect size for the secondary outcomes (i.e., depression and quality of life) and to examine the extent to which specific variables (i.e., sex, age, chemotherapy side effects, pain levels) are consistent with the conceptual model as potential moderators of treatment effect. OUTLINE: This is a pilot study followed by a randomized study. Patients are stratified according to type of cancer (liver, bile duct, gall bladder, and pancreatic vs second-line colorectal, gastric, and esophageal vs lung). - Pilot study: Patients complete qualitative interviews to explore ways that anxiety impacts patients, to identify components of a cognitive-behavioral therapy intervention that are most useful, and to determine the optimal method of delivery for the intervention (e.g., number and timing of interventions, administration during chemotherapy infusions when feasible). Based upon these results a full treatment manual is written for use in the randomized study. Patients are then randomized to 1 of 2 treatment arms. - Arm I (cognitive-behavioral therapy): Patients undergo six 90-minute treatment modules (over 2 months) based on the results of the pilot study. Modules include psychoeducation and motivational interviewing; relaxation training and mindfulness practice; cognitive restructuring; coping with cancer fears; activity planning and pacing; and review, termination, and plan for continued use of skills. - Arm II (routine care): Patients receive routine medical care. At the completion of treatment, all patients meet with a blinded independent assessor to assess outcomes. Patients undergo psychiatric evaluation, including the Hamilton Anxiety Rating Scale (HAM-A), the Montgomery Asberg Depression Rating Scale (MADRS), the Mini International Neuropsychiatric Interview (MINI), and a psychosocial self-reported battery at baseline and 3 months after completing therapy. After completing treatment, patients who underwent routine care (arm II) may undergo cognitive-behavioral therapy as in arm I, if desired.
Criteria: DISEASE CHARACTERISTICS: - Diagnosis of any of the following: - Stage IIIB (with effusions) or IV non-small cell lung cancer - Extensive stage small cell lung cancer - Solid gastrointestinal cancer - Nonresectable - Not being treated for curative intent - Including any of the following diagnoses: - Stage III or IV pancreatic cancer - Stage IV liver cancer - Stage III or IV gallbladder cancer - Stage III or IV bile duct cancer - Stage IVB esophageal cancer - Stage IV gastric cancer - Second-line colorectal cancer (stage IV after a first line of chemotherapy) - At least four weeks post-diagnosis - Current symptoms of anxiety and anxiety as principal psychiatric problem - Patients with co-morbid depression are eligible as long as anxiety symptoms are primary - Undergoing chemotherapy PATIENT CHARACTERISTICS: - No delirium or dementia - No active and untreated major psychiatric condition such as schizophrenia or bipolar disorder, other psychotic disorders, or substance dependence PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Concurrent pharmacotherapy for anxiety allowed
Study is available at: Massachusetts General Hospital
Boston, MA 02114
United States

Primary Contact:
Clinical Trials Office - Massachusetts General Hospital
Phone: 877-726-5130
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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