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

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT01536977

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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	Phase
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	N/A

Detailed Description

PRIMARY OBJECTIVES:

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:

To provide preliminary data on the influence of BBT-I on cancer-related fatigue (CRF) and cognitive status in BMT recipients.
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

Actual Enrollment :

29 participants

Allocation:

N/A

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 :

Mar 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

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 Names: quality of life assessment Other: questionnaire administration Ancillary studies Behavioral: management of therapy complications Undergo BBT-I Other Names: complications of therapy, management of Behavioral: cognitive assessment Ancillary studies Behavioral: educational intervention Undergo BBT-I Other Names: intervention, educational

Arm

Intervention/Treatment

Experimental: Supportive care (BBT-I)

Other: quality-of-life assessment

Ancillary studies

Other Names:

quality of life assessment

Other: questionnaire administration

Ancillary studies

Behavioral: management of therapy complications

Undergo BBT-I

Other Names:

complications of therapy, management of

Behavioral: cognitive assessment

Ancillary studies

Behavioral: educational intervention

Undergo BBT-I

Other Names:

intervention, educational

Outcome Measures

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 [Baseline]
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 [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

Influence of BBT-I on CRF and cognitive status in BMT recipients [Baseline]
Influence of BBT-I on CRF and cognitive status in BMT recipients [6 weeks post-intervention]
Influence of BBT-I on QOL in BMT recipients [Baseline]
Influence of BBT-I on QOL in BMT recipients [6 weeks post-intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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