Behavioral Intervention For BMT/SCT Survivors

Multiple Myeloma Clinical Trial

— BMT/SCT  

Official title:

Cognitive Behavioral Intervention for BMT/SCT Survivors: Looking Forward

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579917
• Other study ID #: 04-139
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: January 5, 2009
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Leukemia
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Non-Hodgkin's Lymphoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Derald H. Ruttenberg Cancer Center, Hackensack University Medical Center, Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		conclusion of study	No
Secondary	Explore the influence of patient and medical factors on the impact of CBT-BMT/SCT.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center