Behavioral Intervention For BMT/SCT Survivors

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00579917

Collaborator

Derald H. Ruttenberg Cancer Center (Other), Icahn School of Medicine at Mount Sinai (Other), Hackensack Meridian Health (Other)

133

Enrollment

Location

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Disease Leukemia Multiple Myeloma Non-Hodgkin's Lymphoma	Behavioral: Cognitive Behavioral Therapy: Questionnaires Behavioral: Usual Care: Questionnaires

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 Design

Study Type:

Observational

Actual Enrollment :

133 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cognitive Behavioral Intervention for BMT/SCT Survivors: Looking Forward

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Explore the influence of patient and medical factors on the impact of CBT-BMT/SCT. [conclusion of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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