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Cognitive Behavioral Intervention for BMT/SCT Survivors: Looking Forward


N/A
18 Years
N/A
Not Enrolling
Both
Hodgkin's Disease, Leukemia, Multiple Myeloma, Non-Hodgkin's Lymphoma

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Trial Information

Cognitive Behavioral Intervention for BMT/SCT Survivors: Looking Forward


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).


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

04-139

NCT ID:

NCT00579917

Start Date:

January 2005

Completion Date:

December 2008

Related Keywords:

  • Hodgkin's Disease
  • Leukemia
  • Multiple Myeloma
  • Non-Hodgkin's Lymphoma
  • Survivor
  • Behavioral Intervention
  • Bone Marrow
  • Stem Cell Transplantation
  • Hodgkin Disease
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021