|Phase II||Educational/Counseling/Training, Supportive care||Completed||Over 18||NCI, Other||CDR0000597438|
1R03CA128478-01, 2007P000368, MGH-2007-P-000368, NCT00706290
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.
Further Study Information
- 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.
- 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
- 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
Trial Lead Organizations/Sponsors
Massachusetts General HospitalNational Cancer Institute
|Joseph Greer||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00706290
ClinicalTrials.gov processed this data on October 17, 2013
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