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


N/A
21 Years
N/A
Open (Enrolling)
Both
Cognition Disorders, Fatigue, Sleep Disorders, Other Complications of Bone Marrow Transplant

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Description:

The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable.

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Oxana Palesh

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

BMT242

NCT ID:

NCT01536977

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Cognition Disorders
  • Fatigue
  • Sleep Disorders
  • Other Complications of Bone Marrow Transplant
  • quality of life
  • Cognition Disorders
  • Fatigue
  • Sleep Disorders
  • Dyssomnias
  • Parasomnias

Name

Location

Stanford UniversityStanford, California  94305