Cognition Disorders, Fatigue, Other Complications of Bone Marrow Transplant, Sleep Disorders
Conditions
Keywords
quality of life
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.
Interventions
OTHERquality-of-life assessment
Ancillary studies
OTHERquestionnaire administration
Ancillary studies
BEHAVIORALmanagement of therapy complications
Undergo BBT-I
BEHAVIORALcognitive assessment
Ancillary studies
BEHAVIORALeducational intervention
Undergo BBT-I
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Influence of BBT-I on CRF and cognitive status in BMT recipients | Baseline |
| Influence of BBT-I on QOL in BMT recipients | Baseline |
Countries
United States
Outcome results
None listed