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

• 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 ]
  

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.