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

Purpose

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	Intervention
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

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Fatigue Sleep Disorders

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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: 1 month follow-up ] [ Designated as safety issue: No ]
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 months post-BMT ] [ Designated as safety issue: No ]
The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable.

Secondary Outcome Measures:

Influence of BBT-I on CRF and cognitive status in BMT recipients [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Influence of BBT-I on CRF and cognitive status in BMT recipients [ Time Frame: 6 weeks post-intervention ] [ Designated as safety issue: No ]
Influence of BBT-I on CRF and cognitive status in BMT recipients [ Time Frame: 1 month follow-up ] [ Designated as safety issue: No ]
Influence of BBT-I on CRF and cognitive status in BMT recipients [ Time Frame: 6 months post-BMT ] [ Designated as safety issue: No ]
Influence of BBT-I on QOL in BMT recipients [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Influence of BBT-I on QOL in BMT recipients [ Time Frame: 6 weeks post-intervention ] [ Designated as safety issue: No ]
Influence of BBT-I on QOL in BMT recipients [ Time Frame: 1 month follow-up ] [ Designated as safety issue: No ]
Influence of BBT-I on QOL in BMT recipients [ Time Frame: 6 months post-BMT ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2012
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536977

Contacts

Contact: Oxana Palesh	650-725-7011	opalesh@stanford.edu
Contact: Cancer Clinical Trials Office	650-498-7061	cctoffice@stanford.edu

Locations

United States, California
Stanford University	Recruiting
Stanford, California, United States, 94305
Contact: Oxana Palesh 650-725-7011 oxana.palesh@stanford.edu
Principal Investigator: Oxana Palesh
Sub-Investigator: Laura Johnston
Sub-Investigator: Charlie Kamen
Sub-Investigator: Shelli Kesler
Sub-Investigator: Robert Rotatori

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Oxana Palesh

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT01536977 History of Changes
Other Study ID Numbers:	BMT242, NCI-2012-00117, SU-11112011-8650
Study First Received:	February 16, 2012
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Stanford University:

quality of life

Additional relevant MeSH terms:

Cognition Disorders
Fatigue
Sleep Disorders
Dyssomnias
Parasomnias

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

ClinicalTrials.gov processed this record on May 22, 2013