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

Stanford University29 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cognition Disorders Fatigue Sleep Disorders Other Complications of Bone Marrow Transplant

Interventions

quality-of-life assessmentOTHER

Ancillary studies

questionnaire administrationOTHER

Ancillary studies

management of therapy complicationsBEHAVIORAL

Undergo BBT-I

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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

The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable.

Time frame: Baseline

Feasibility and efficacy of BBT-I on insomnia in HCT recipients as calculated by means, standard deviations and effect sizes on the ISI variable

The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable.

Time frame: 6 weeks post-intervention

Secondary Outcomes

Influence of BBT-I on CRF and cognitive status in BMT recipients

Time frame: Baseline

Influence of BBT-I on CRF and cognitive status in BMT recipients

Time frame: 6 weeks post-intervention

Influence of BBT-I on QOL in BMT recipients

Time frame: Baseline

Influence of BBT-I on QOL in BMT recipients

Time frame: 6 weeks post-intervention

Data from ClinicalTrials.gov

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