Behavioral Intervention For BMT/SCT Survivors
BMT/SCT
Cognitive Behavioral Intervention for BMT/SCT Survivors: Looking Forward
1 other identifier
observational
133
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
December 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 7, 2009
January 1, 2009
3.9 years
December 19, 2007
January 5, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Explore the influence of patient and medical factors on the impact of CBT-BMT/SCT.
conclusion of study
Study Arms (2)
1 Cognitive-behavioral therapy (CBT)
Cognitive-behavioral therapy (CBT) involves one-on-one counseling
2 Usual Care
Usual Care
Interventions
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.
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.
Eligibility Criteria
Primary care clinics
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Derald H. Ruttenberg Cancer Centercollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
- Hackensack Meridian Healthcollaborator
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 19, 2007
First Posted
December 24, 2007
Study Start
January 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 7, 2009
Record last verified: 2009-01