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

Stanford University

Status: Completed

Conditions: Sleep Disorders; Cognition Disorders; Other Complications of Bone Marrow Transplant; Fatigue

Treatments: Behavioral: educational intervention; Behavioral: cognitive assessment; Other: questionnaire administration; Other: quality-of-life assessment; Behavioral: management of therapy complications

Study type: Interventional

Funder types: Other

Identifiers

NCT01536977

SU-11112011-8650 (Other Identifier)

BMT242

NCI-2012-00117 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Supportive care (BBT-I)

Experimental group

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.

Treatment:

Behavioral: management of therapy complications

Behavioral: cognitive assessment

Other: quality-of-life assessment

Behavioral: educational intervention

Other: questionnaire administration