Phase II Early Behavioral Intervention in BMT w/ Sleep Disturbance-Assess QOL+Fatigue+Cognitive f(x)
NCT ID: NCT01536977
Last Updated: 2014-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2012-03-31
2013-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (BBT-I)
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.
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
management of therapy complications
Undergo BBT-I
cognitive assessment
Ancillary studies
educational intervention
Undergo BBT-I
Interventions
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quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
management of therapy complications
Undergo BBT-I
cognitive assessment
Ancillary studies
educational intervention
Undergo BBT-I
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Oxana Palesh
Assistant Professor of Psychiatry and Behavioral Science
Principal Investigators
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Oxana Palesh
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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Other Identifiers
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NCI-2012-00117
Identifier Type: REGISTRY
Identifier Source: secondary_id
SU-11112011-8650
Identifier Type: OTHER
Identifier Source: secondary_id
BMT242
Identifier Type: -
Identifier Source: org_study_id
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