Clinical trial NCT00706290: Brief CBT for Anxiety and Advanced Cancer
Official title: Brief CBT for Anxiety and Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Depression
Unspecified Adult Solid Tumor, Protocol Specific
Cancer
Cognitive Behavioral Therapy
Keywords: anxiety
depression
quality of life
psychosocial effects of cancer and its treatment
advanced cancer
metastatic cancer
stage IV cancer
cognitive behavioral therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-06-27
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Providing cognitive-behavioral therapy (CBT) may reduce anxiety and improve quality of life of patients with advanced cancer.

PURPOSE: To examine the development and pilot testing of a brief cognitive-behavioral therapy intervention to treat anxiety and improve quality of life in patients with advanced cancer.

Hypothesis: Patients with anxiety associated with advanced cancer who receive CBT will report significantly fewer anxiety symptoms compared to those in the comparison condition.

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 cancer.
* To estimate the effect size of a manualized cognitive-behavioral intervention to reduce anxiety in patients with advanced 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.

* 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-seven 90-minute treatment sessions (over 2 months) based on the results of the pilot study. Modules include psychoeducation and goal setting; relaxation training; 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 participants 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 after 2-3 months.

After completing treatment, patients who underwent routine care (arm II) may undergo cognitive-behavioral therapy as in arm I, if desired.

Eligibility criteria: INCLUSION CRITERIA:

* Diagnosis of incurable solid tumor cancers
* 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
  * Concurrent pharmacotherapy for anxiety allowed

EXCLUSION CRITERIA:

* Delirium or dementia
* Active and untreated major psychiatric condition such as schizophrenia or bipolar disorder, other psychotic disorders, or substance dependence
* Other inability to complete informed consent process or study procedures

Primary outcomes:
measure: Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale
timeFrame: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
Secondary outcomes:
measure: Depression as measured by the Montgomery Asberg Depression Rating Scale
timeFrame: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
measure: Quality of life as measured by the Functional Assessment of Scale Cancer Therapy (FACT-G)
timeFrame: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Greer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greer JA, Traeger L, Bemis H, Solis J, Hendriksen ES, Park ER, Pirl WF, Temel JS, Prigerson HG, Safren SA. A pilot randomized controlled trial of brief cognitive-behavioral therapy for anxiety in patients with terminal cancer. Oncologist. 2012;17(10):1337-45. doi: 10.1634/theoncologist.2012-0041. Epub 2012 Jun 11.
citation: Greer JA, Park ER, Prigerson HG, Safren SA. Tailoring Cognitive-Behavioral Therapy to Treat Anxiety Comorbid with Advanced Cancer. J Cogn Psychother. 2010 Jan 1;24(4):294-313. doi: 10.1891/0889-8391.24.4.294.