- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00579917
Behavioral Intervention For BMT/SCT Survivors (BMT/SCT)
Cognitive Behavioral Intervention for BMT/SCT Survivors: Looking Forward
Study Overview
Status
Intervention / Treatment
Detailed Description
The use of bone marrow and stem cell transplantation (BMT/SCT) in the treatment of cancer has increased five-fold over the last decade. Among the cancers treated with BMT/SCT are Hodgkin's Lymphoma, non-Hodgkin's Lymphoma, multiple myeloma, and leukemias such as acute lymphoblastic (ALL), acute myelogenous (AML), chronic lymphocytic (CLL), and chronic myelogenous (CML). With the development of non-myeloablative transplants (either "mini" or reduced intensity transplants) for patients unable to tolerate standard BMT/SCT, the use of this procedure is expected to increase substantially over the next five years. BMT/SCT adversely affects almost every aspect of the patient's life (1;2). A standard (fully ablative) transplant involves conditioning with dose intensive chemotherapy, with or without total body irradiation.
Although various medical regimens and supportive psychosocial services are used to reduce the intensity of these side effects, symptoms may persist. Moreover, the drugs used to control side effects often have aversive side effects of their own. Thus, patients must tolerate a protracted course of treatment that is highly aversive and invasive at a time when their lives are disrupted and they are fearful about their survival. A common complaint among survivors is that such problems go unaddressed, and these types of adjustment problems appear to become most intense in the first year post treatment, when physical functioning has stabilized and contact with the BMT/SCT clinical care team wanes (5;10).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Have significant psychological distress measured by either:
- PTSD ONLY - score of 1.0 standard deviation above the mean on the PTSD Checklist-Civilian (PCL-C), or score meets PCL-C symptom cluster criteria for 3 symptom clusters (i.e. re-experiencing, numbing and avoidance combined, and hyperarousal) or 4 symptom clusters (i.e., re-experiencing, numbing only, avoidance only, and hyperarousal); or
- DISTRESS WITH SOME PTSD - score meets clinically significant impairment on the Brief Symptom Inventory (BSI) global distress index and score meets PCL-C symptom cluster criteria for at least one PCL-C symptom cluster of 3 symptom clusters (i.e. re-experiencing, numbing and avoidance combined, and hyperarousal) or 4 symptom clusters (i.e., re-experiencing, numbing only, avoidance only, and hyperarousal)
- Do not have a substance abuse disorder
- Do not have cognitive impairment as indicated by a score of 3 or lower on the Mini-Mental Status Exam
- Absence of psychotic symptomatology
- Do not have active suicidal ideation
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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1 Cognitive-behavioral therapy (CBT)
Cognitive-behavioral therapy (CBT) involves one-on-one counseling
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CBT, we will interview you again after you have completed the 10 sessions.
We call these follow-up interviews, and they include several phone calls and a questionnaire you would be asked to complete and then mail in.
Each follow-up interview will take between 60 and 210 minutes.
If you wish, these follow-up interviews can be done over different days.
We will do the follow-up interviews three times; at approximately 4 months, 7 months, and 10 months after you complete the baseline interview.
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2 Usual Care
Usual Care
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If you receive Usual Care, you will not receive CBT while you are in the study.
You will complete the questionnaires at the same time as participants who receive CBT.
If you receive Usual Care you will be offered 10 sessions of CBT at no charge at the end of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Test the efficacy of a ten-session cognitive-behavioral intervention (CBT-BMT/SCT) on cancer-specific anxiety, psychological distress, and quality of life concerns among BMT/SCT survivors.
Time Frame: conclusion of study
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conclusion of study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Explore the influence of patient and medical factors on the impact of CBT-BMT/SCT.
Time Frame: conclusion of study
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conclusion of study
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Lymphoma
- Multiple Myeloma
- Hodgkin Disease
Other Study ID Numbers
- 04-139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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