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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00117 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| SU-11112011-8650 | Other Identifier | Stanford University |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (BBT-I) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quality-of-life assessment | Other | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and efficacy of BBT-I on insomnia in HCT recipients as calculated by means, standard deviations and effect sizes on the Insomnia Severity Inventory (ISI) total score variable | The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable. | Baseline |
| Feasibility and efficacy of BBT-I on insomnia in HCT recipients as calculated by means, standard deviations and effect sizes on the ISI variable | The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable. | 6 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of BBT-I on CRF and cognitive status in BMT recipients | Baseline | |
| Influence of BBT-I on CRF and cognitive status in BMT recipients | 6 weeks post-intervention | |
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Patients proceeding to BMT within the Stanford Adult BMT program will be screened for eligibility
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oxana Palesh | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| questionnaire administration | Other | Ancillary studies |
|
| management of therapy complications | Behavioral | Undergo BBT-I |
|
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| cognitive assessment | Behavioral | Ancillary studies |
|
| educational intervention | Behavioral | Undergo BBT-I |
|
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| Influence of BBT-I on QOL in BMT recipients |
| Baseline |
| Influence of BBT-I on QOL in BMT recipients | 6 weeks post-intervention |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D005221 | Fatigue |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
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