Behavioral Intervention For BMT/SCT Survivors (BMT/SCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00579917|
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : January 7, 2009
|Condition or disease||Intervention/treatment|
|Hodgkin's Disease Leukemia Multiple Myeloma Non-Hodgkin's Lymphoma||Behavioral: Cognitive Behavioral Therapy: Questionnaires Behavioral: Usual Care: Questionnaires|
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 :||Observational|
|Actual Enrollment :||133 participants|
|Official Title:||Cognitive Behavioral Intervention for BMT/SCT Survivors: Looking Forward|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
1 Cognitive-behavioral therapy (CBT)
Cognitive-behavioral therapy (CBT) involves one-on-one counseling
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.
2 Usual Care
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.
- 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 ]
- Explore the influence of patient and medical factors on the impact of CBT-BMT/SCT. [ Time Frame: conclusion of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579917
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|