Phase II Early Behavioral Intervention in BMT w/ Sleep Disturbance-Assess QOL+Fatigue+Cognitive f(x)
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies, Insomnia Sleep Studies, Other Indications |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 5/5/2014 |
| Start Date: | March 2012 |
| Contact: | Oxana Palesh |
| Email: | opalesh@stanford.edu |
| Phone: | 650-725-7011 |
Early Behavioral Intervention in BMT Recipients With Sleep Disturbance: Assessing Its Impact on Quality of Life, Fatigue and Cognitive Function
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
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
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.
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.
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
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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