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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536977
• Other study ID #: BMT242
• Secondary ID: NCI-2012-00117SU
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: May 29, 2014
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Other:
• quality-of-life assessment
Ancillary studies
• questionnaire administration
Ancillary studies

Behavioral:
• management of therapy complications
Undergo BBT-I
• cognitive assessment
Ancillary studies
• educational intervention
Undergo BBT-I

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline	No
Primary	Feasibility and efficacy of BBT-I on insomnia in HCT recipients as calculated by means, standard deviations and effect sizes on the ISI variable	The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable.	6 weeks post-intervention	No
Secondary	Influence of BBT-I on CRF and cognitive status in BMT recipients		Baseline	No
Secondary	Influence of BBT-I on CRF and cognitive status in BMT recipients		6 weeks post-intervention	No
Secondary	Influence of BBT-I on QOL in BMT recipients		Baseline	No
Secondary	Influence of BBT-I on QOL in BMT recipients		6 weeks post-intervention	No