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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Derald H. Ruttenberg Cancer Center Mount Sinai School of Medicine Hackensack University Medical Center |
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| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00579917 |
Purpose
The purpose of this study is to understand how to help survivors of bone marrow transplant and stem cell transplant (BMT/SCT) with emotional distress. BMT/SCT has become a more common type of treatment for cancer or hematological disorder (blood disease). For this reason, there is concern that adjustment after treatment may be difficult for many persons. We have found that about 25% of BMT/SCT survivors still feel anxious and distressed about their illness and its treatment after at least one year following transplant. This study is one of the first to study the impact of counseling on BMT/SCT survivors. The study is being carried out at Memorial Sloan-Kettering Cancer Center, Mount Sinai Medical Center, and Hackensack University Medical Center.
| Condition | Intervention |
|---|---|
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Hodgkin's Disease Leukemia Multiple Myeloma Non-Hodgkin's Lymphoma |
Behavioral: Cognitive Behavioral Therapy: Questionnaires Behavioral: Usual Care: Questionnaires |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Cognitive Behavioral Intervention for BMT/SCT Survivors: Looking Forward |
| Enrollment: | 133 |
| Study Start Date: | January 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
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1 Cognitive-behavioral therapy (CBT)
Cognitive-behavioral therapy (CBT) involves one-on-one counseling
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Behavioral: Cognitive Behavioral Therapy: Questionnaires
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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Behavioral: Usual Care: Questionnaires
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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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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Primary care clinics
Inclusion Criteria:
Have significant psychological distress measured by either:
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Katherine Duhamel, MD ) |
| Study ID Numbers: | 04-139 |
| Study First Received: | December 19, 2007 |
| Last Updated: | January 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00579917 |
| Health Authority: | United States: Institutional Review Board |
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Survivor Behavioral Intervention Bone Marrow Stem Cell Transplantation |
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Hodgkin's disease Immunoproliferative Disorders Hematologic Diseases Blood Protein Disorders Hodgkin lymphoma, adult Blood Coagulation Disorders Lymphoma, small cleaved-cell, diffuse Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Leukemia Lymphatic Diseases Hemorrhagic Disorders Multiple myeloma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Hodgkin Disease Neoplasms, Plasma Cell |
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Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |
