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

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ClinicalTrials.gov Identifier: NCT01536977
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Cognition Disorders Fatigue Sleep Disorders Other Complications of Bone Marrow Transplant Other: quality-of-life assessment Other: questionnaire administration Behavioral: management of therapy complications Behavioral: cognitive assessment Behavioral: educational intervention

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.

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early Behavioral Intervention in BMT Recipients With Sleep Disturbance: Assessing Its Impact on Quality of Life, Fatigue and Cognitive Function
Study Start Date : March 2012
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Supportive care (BBT-I)
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
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Behavioral: management of therapy complications
Undergo BBT-I
Other Name: complications of therapy, management of
Behavioral: cognitive assessment
Ancillary studies
Behavioral: educational intervention
Undergo BBT-I
Other Name: intervention, educational


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Influence of BBT-I on CRF and cognitive status in BMT recipients [ Time Frame: Baseline ]
  2. Influence of BBT-I on CRF and cognitive status in BMT recipients [ Time Frame: 6 weeks post-intervention ]
  3. Influence of BBT-I on QOL in BMT recipients [ Time Frame: Baseline ]
  4. Influence of BBT-I on QOL in BMT recipients [ Time Frame: 6 weeks post-intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536977


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Oxana Palesh Stanford University
More Information

Responsible Party: Oxana Palesh, Assistant Professor of Psychiatry and Behavioral Science, Stanford University
ClinicalTrials.gov Identifier: NCT01536977     History of Changes
Other Study ID Numbers: BMT242
NCI-2012-00117 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SU-11112011-8650 ( Other Identifier: Stanford University )
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014

Keywords provided by Oxana Palesh, Stanford University:
quality of life

Additional relevant MeSH terms:
Disease
Fatigue
Sleep Wake Disorders
Parasomnias
Dyssomnias
Cognition Disorders
Pathologic Processes
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Neurocognitive Disorders