Early Behavioral Intervention in BMT Recipients With Sleep Disturbance: Assessing Its Impact on Quality of Life, Fatigue and Cognitive Function
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.
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
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.
Patients proceeding to BMT within the Stanford Adult BMT program will be screened for
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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.
United States: Food and Drug Administration
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