Clinical trial NCT01536977: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cognition Disorders
Fatigue
Sleep Disorders
Other Complications of Bone Marrow Transplant
Keywords: quality of life
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-02-22
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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
timeFrame: Baseline
measure: Feasibility and efficacy of BBT-I on insomnia in HCT recipients as calculated by means, standard deviations and effect sizes on the ISI variable
timeFrame: 6 weeks post-intervention
Secondary outcomes:
measure: Influence of BBT-I on CRF and cognitive status in BMT recipients
timeFrame: Baseline
measure: Influence of BBT-I on CRF and cognitive status in BMT recipients
timeFrame: 6 weeks post-intervention
measure: Influence of BBT-I on QOL in BMT recipients
timeFrame: Baseline
measure: Influence of BBT-I on QOL in BMT recipients
timeFrame: 6 weeks post-intervention
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Oxana Palesh
role: PRINCIPAL_INVESTIGATOR
References: