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Completed

NCT Number: NCT01536977

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

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

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Key information

Conditions

Cognition Disorders Fatigue Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Other Complications of Bone Marrow Transplant Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality-of-Life Assessment

Other

Ancillary studies

Other names: quality of life assessment

Questionnaire Administration

Other

Ancillary studies

management of therapy complications

Behavioral

Undergo BBT-I

Other names: complications of therapy, management of

Cognitive assessment

Behavioral

Ancillary studies

Educational intervention

Behavioral

Undergo BBT-I

Other names: intervention, educational

Primary outcomes

  1. 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

    Time frame: Baseline

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

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

    Time frame: 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 outcomes

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

    Time frame: Baseline

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

    Time frame: 6 weeks post-intervention

  3. Influence of BBT-I on QOL in BMT recipients

    Time frame: Baseline

  4. Influence of BBT-I on QOL in BMT recipients

    Time frame: 6 weeks post-intervention

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Early Behavioral Intervention in BMT Recipients With Sleep Disturbance: Assessing Its Impact on Quality of Life, Fatigue and Cognitive Function

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 22, 2012
Registry last updated
Jun 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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