Early Behavioral Intervention in BMT Recipients With Sleep Disturbance: Assessing Its Impact on Quality of Life, Fatigue and Cognitive Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Time Frame: Baseline
The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable.
Feasibility and efficacy of BBT-I on insomnia in HCT recipients as calculated by means, standard deviations and effect sizes on the ISI variable
Time Frame: 6 weeks post-intervention
The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable.
Secondary Outcomes
- 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(6 weeks post-intervention)
Investigators
Oxana Palesh
Assistant Professor of Psychiatry and Behavioral Science
Stanford University