search
Back to results

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

Primary Purpose

Cognition Disorders, Fatigue, Sleep Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
quality-of-life assessment
questionnaire administration
management of therapy complications
cognitive assessment
educational intervention
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognition Disorders focused on measuring quality of life

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (BBT-I)

Arm Description

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.

Outcomes

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
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
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
Influence of BBT-I on CRF and cognitive status in BMT recipients
Influence of BBT-I on QOL in BMT recipients
Influence of BBT-I on QOL in BMT recipients

Full Information

First Posted
February 16, 2012
Last Updated
May 29, 2014
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT01536977
Brief Title
Phase II Early Behavioral Intervention in BMT w/ Sleep Disturbance-Assess QOL+Fatigue+Cognitive f(x)
Official Title
Early Behavioral Intervention in BMT Recipients With Sleep Disturbance: Assessing Its Impact on Quality of Life, Fatigue and Cognitive Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorders, Fatigue, Sleep Disorders, Other Complications of Bone Marrow Transplant
Keywords
quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (BBT-I)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
management of therapy complications
Other Intervention Name(s)
complications of therapy, management of
Intervention Description
Undergo BBT-I
Intervention Type
Behavioral
Intervention Name(s)
cognitive assessment
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Undergo BBT-I
Primary Outcome Measure Information:
Title
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
Description
The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable.
Time Frame
Baseline
Title
Feasibility and efficacy of BBT-I on insomnia in HCT recipients as calculated by means, standard deviations and effect sizes on the ISI variable
Description
The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable.
Time Frame
6 weeks post-intervention
Secondary Outcome Measure Information:
Title
Influence of BBT-I on CRF and cognitive status in BMT recipients
Time Frame
Baseline
Title
Influence of BBT-I on CRF and cognitive status in BMT recipients
Time Frame
6 weeks post-intervention
Title
Influence of BBT-I on QOL in BMT recipients
Time Frame
Baseline
Title
Influence of BBT-I on QOL in BMT recipients
Time Frame
6 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oxana Palesh
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs