View Clinical Trial (Medical Research Study)
Early Behavioral Intervention in BMT Recipients With Sleep Disturbance: Assessing Its Impact on Quality of Life, Fatigue and Cognitive Function
| City: |
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Stanford |
| State: |
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California |
| Zip Code: |
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94305 |
| Conditions: |
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Cognition Disorders - Fatigue - Sleep Disorders - Other Complications of Bone Marrow Transplant |
| Purpose: |
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This pilot clinical trial studies early brief behavioral intervention in treating sleep
disturbance and improving quality of life in patients undergoing bone marrow transplant
(BMT). A brief behavioral intervention may reduce symptoms of insomnia and fatigue and
improve quality of life and cognitive function in patients undergoing BMT
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| Study Summary: |
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PRIMARY OBJECTIVES:
I. To provide preliminary data on the feasibility and efficacy of brief behavioral treatment
for insomnia (BBT-I) on insomnia in hematopoietic cell transplant (HCT) recipients.
SECONDARY OBJECTIVES:
I. To provide preliminary data on the influence of BBT-I on cancer-related fatigue (CRF) and
cognitive status in BMT recipients.
II. To provide preliminary data on the influence of BBT-I on quality-of-life (QOL) in BMT
recipients.
OUTLINE:
Patients complete the BBT-I, comprising the following modules: 1) "What to expect" in terms
of fatigue and insomnia as it occurs with cancer and cancer treatment; 2) A review of the
Spielman Model of insomnia; 3) A discussion (based on the Spielman Model) regarding how
insomnia and fatigue may co-occur and interact in the context of cancer and cancer
treatment; 4) An introduction to the concept and practice of Stimulus Control Therapy; 5) An
introduction to Sleep Scheduling Specifically modified for cancer patients; 6) Sleep
Compression; and 7) Concomitant Medications and Substance Use.
After completion of study treatment, patients are followed up at 1 month.
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| Criteria: |
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Patients proceeding to BMT within the Stanford Adult BMT program will be screened for
eligibility
Inclusion Criteria:
- Patient is scheduled to receive bone marrow transplantation.
- Patient has a diagnosis of Non-Hodgkin's Lymphoma
- Patient is at least 21 years old
- Patient is able to understand written and spoken English
- has preferred sleep phase between 9:00 pm and 3:00 am and a habitual rise time
between 4:00 am and 11:00 am
- Patient receives a score of 8 or more on the Insomnia Severity Index or takes sleep
medications 3 times a week
Exclusion criteria:
- Has an unstable medical or psychiatric illness (Axis I - current or within the last 5
years)
- Existing cognitive disability
- Is currently pregnant or nursing
- Has a history of substance abuse or meets criteria for current alcohol abuse or
dependence
- Has a self-reported history of chronic pre-existing insomnia, sleep apnea or RSL
syndrome
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| NCT ID: |
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NCT01536977 |
| Primary Contact: |
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Principal Investigator
Oxana Palesh
Stanford University
Oxana Palesh
Phone: 650-725-7011
Email: opalesh@stanford.edu
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| Backup Contact: |
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Email: cctoffice@stanford.edu
Cancer Clinical Trials Office
Phone: 650-498-7061
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| Location Contact: |
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Stanford, California 94305
United States
Oxana Palesh
Phone: 650-725-7011
Email: oxana.palesh@stanford.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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