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

NCT01536977 | Completed DMC

• 3 other identifiers: BMT242NCI-2012-00117SU-11112011-8650
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Cognition Disorders; Fatigue; Sleep Disorders; Other Complications of Bone Marrow Transplant

Keywords

quality of life

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 weeks post-intervention

Secondary Outcomes (4)

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

  Baseline

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

  6 weeks post-intervention

• Influence of BBT-I on QOL in BMT recipients

  Baseline

• Influence of BBT-I on QOL in BMT recipients

  6 weeks post-intervention

Study Arms (1)

Supportive care (BBT-I)

EXPERIMENTAL

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.

Other: quality-of-life assessment; Other: questionnaire administration; Behavioral: management of therapy complications; Behavioral: cognitive assessment; Behavioral: educational intervention

Interventions

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Supportive care (BBT-I)

questionnaire administration OTHER

Ancillary studies

Supportive care (BBT-I)

management of therapy complications BEHAVIORAL

Undergo BBT-I

Also known as: complications of therapy, management of

Supportive care (BBT-I)

cognitive assessment BEHAVIORAL

Ancillary studies

Supportive care (BBT-I)

educational intervention BEHAVIORAL

Undergo BBT-I

Also known as: intervention, educational

Supportive care (BBT-I)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cognition Disorders; Fatigue; Sleep Wake Disorders

Interventions

Mental Status and Dementia Tests; Early Intervention, Educational; Methods

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques

Study Officials

• Oxana Palesh

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Behavioral Science

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

US (1)