Cognitive and Behavioral Therapy or Standard Care in Patients With Advanced Gastrointestinal Cancer or Lung Cancer - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00706290

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.

Condition	Intervention
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	Other: counseling intervention Other: educational intervention Other: questionnaire administration Procedure: meditation therapy Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: standard follow-up care

Study Type:	Interventional
Study Design:	Allocation: Randomized
Official Title:	Brief CBT for Anxiety and Advanced Cancer

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Colorectal Cancer Depression Esophageal Cancer Esophagus Disorders Liver Cancer Lung Cancer Pancreatic Cancer Stomach Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale [ Designated as safety issue: No ]

Secondary Outcome Measures:

Depression as measured by the Montgomery Asberg Depression Rating Scale [ Designated as safety issue: No ]
Quality of life as measured by the Functional Assessment of Scale Cancer Therapy [ Designated as safety issue: No ]
Functional impairment as measured by the Sheehan Disability Scale and the Global Assessment of Functioning [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2007
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706290

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Joseph Greer, PhD

Massachusetts General Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00706290 History of Changes
Other Study ID Numbers:	CDR0000597438, MGH-2007-P-000368
Study First Received:	June 26, 2008
Last Updated:	July 14, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

depression
psychosocial effects of cancer and its treatment
extensive stage small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
stage III pancreatic cancer
stage IV pancreatic cancer
advanced adult primary liver cancer
unresectable gallbladder cancer

unresectable extrahepatic bile duct cancer
stage IV esophageal cancer
stage IV gastric cancer
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer
anxiety disorder

Additional relevant MeSH terms:

Anxiety Disorders
Colorectal Neoplasms
Depression
Depressive Disorder
Esophageal Diseases
Esophageal Neoplasms
Liver Neoplasms
Lung Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Gastrointestinal Neoplasms
Mental Disorders
Intestinal Neoplasms

Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Behavioral Symptoms
Mood Disorders
Head and Neck Neoplasms
Liver Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on February 09, 2012