NCT01536977

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognition Disorders
• Fatigue
• Sleep Disorders
• Other Complications of Bone Marrow Transplant

Interventions

Type	Name	Description
OTHER	quality-of-life assessment	Ancillary studies
OTHER	questionnaire administration	Ancillary studies
BEHAVIORAL	management of therapy complications	Undergo BBT-I
BEHAVIORAL	cognitive assessment	Ancillary studies
BEHAVIORAL	educational intervention	Undergo BBT-I

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-02-22
• Last updated: 2014-06-02

Locations

1 site across 1 country: United States