Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Cognitive and Behavioral Therapy or Standard Care in Patients With Advanced Gastrointestinal Cancer or Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Educational/Counseling/Training, Supportive care	Active	Over 18	NCI	MGH-2007-P-000368 2007-P-000368, NCT00706290

Objectives

1. 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.
2. To estimate the effect size of a manualized cognitive-behavioral intervention to reduce anxiety in patients with advanced lung or gastrointestinal cancer.
3. 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.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics
• Concurrent pharmacotherapy for anxiety allowed

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

Expected Enrollment

Outcomes

Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale

Depression as measured by the Montgomery Asberg Depression Rating Scale
Quality of life as measured by the Functional Assessment of Scale Cancer Therapy
Functional impairment as measured by the Sheehan Disability Scale and the Global Assessment of Functioning

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.

Trial Contact Information

Trial Lead Organizations

Massachusetts General Hospital

Joseph Greer, PhD, Principal investigator		Ph: 617-643-2143; 877-726-5130

U.S.A.
Massachusetts
	Boston
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  877-726-5130

See All Trial Sites

Registry Information
Official Title		Brief CBT for Anxiety and Advanced Cancer
Trial Start Date		2007-04-13
Trial Completion Date		2009-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00706290
Date Submitted to PDQ		2008-05-29
Information Last Verified		2008-12-21
NCI Grant/Contract Number		CA128478