Phase II Early Behavioral Intervention in BMT w/ Sleep Disturbance-Assess QOL+Fatigue+Cognitive f(x)

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Early Behavioral Intervention in BMT Recipients With Sleep Disturbance: Assessing Its Impact on Quality of Life, Fatigue and Cognitive Function

Conditions
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Cognition Disorders, Fatigue, Sleep Disorders, Other Complications of Bone Marrow Transplant

Intervention / Treatment
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* Other: quality-of-life assessment
* Other: questionnaire administration
* Behavioral: management of therapy complications
* Behavioral: cognitive assessment
* Behavioral: educational intervention


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (BBT-I)<br>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. | Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>Behavioral: management of therapy complications<br>* Undergo BBT-I<br>* Other names: complications of therapy, management of;Behavioral: cognitive assessment<br>* Ancillary studies<br>Behavioral: educational intervention<br>* Undergo BBT-I<br>* Other names: intervention, educational;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Influence of BBT-I on QOL in BMT recipients |  | Baseline | 
| Influence of BBT-I on QOL in BMT recipients |  | 6 weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life