Brief CBT for Anxiety and Advanced Cancer
3 other identifiers
interventional
49
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 anxiety
Started Apr 2007
Typical duration for phase_2 anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 26, 2008
CompletedFirst Posted
Study publicly available on registry
June 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJune 6, 2014
June 1, 2014
3.3 years
June 26, 2008
June 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale
The Hamilton Anxiety Ratings Scale (HAM-A) consists of 14 items that provide an overall measure of global anxiety.
1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
Secondary Outcomes (2)
Depression as measured by the Montgomery Asberg Depression Rating Scale
1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
Quality of life as measured by the Functional Assessment of Scale Cancer Therapy (FACT-G)
1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
Study Arms (2)
Intervention - CBT
EXPERIMENTALParticipants randomized to the intervention group received cognitive behavioral therapy (CBT) for anxiety after completing a baseline assessment consisting of clinician administered psychiatric evaluations and a psychosocial self-report battery. After completing the CBT intervention, consisting of 6-7 sessions over the course of 2-3 months, participants completed a post-intervention assessment identical to the baseline.
Routine Care Control
NO INTERVENTIONParticipants randomized to the control condition completed a baseline assessment consisting of clinician administered psychiatric evaluations and a psychosocial self-report battery. They then received routine medical care. After 2 months and after completing the post clinical assessment identical to the baseline, they were offered the opportunity to receive the CBT intervention for free. This ensured that all participants ultimately received cognitive-behavioral therapy if desired, while permitting an examination of the effect size for the intervention compared to routine care.
Interventions
The cognitive-behavioral intervention consists of 6-7 sessions lasting 60-90 minutes each focused on psycho-education; relaxation training; cognitive-restructuring and coping with cancer fears; and activity planning and pacing. Sessions are delivered by a licensed clinical psychologist or trained psychology fellow or graduate student.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
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.
PMID: 22688670RESULTGreer 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.
PMID: 21234281RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Greer, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant in Psychology
Study Record Dates
First Submitted
June 26, 2008
First Posted
June 27, 2008
Study Start
April 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
June 6, 2014
Record last verified: 2014-06