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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03CA128478-01 | U.S. NIH Grant/Contract | View source | |
| 2007P000368 | Other Identifier | Partners Human Research Committee Protocol Number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a pilot study followed by a randomized study. Patients are stratified according to type of cancer.
Patients are then randomized to 1 of 2 treatment arms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - CBT | Experimental | Participants 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. |
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| Routine Care Control | No Intervention | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Cognitive Behavioral Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Depression as measured by the Montgomery Asberg Depression Rating Scale | The Montgomery Asberg Depression Rating Scale (MADRS) is an empirically derived 10-item interview that measures depression symptoms. | 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) |
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INCLUSION CRITERIA:
Diagnosis of incurable solid tumor cancers
At least four weeks post-diagnosis
Current symptoms of anxiety and anxiety as principal psychiatric problem
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Greer, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22688670 | Result | 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. | |
| 21234281 | Result | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009385 | Neoplastic Processes |
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Consisting of 28 items, the FACT-G has four subscales assessing physical, functional, emotional, and social well-being during the past 7 days. Higher scores on the total score and each subscale indicate better quality of life. |
| 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment) |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |