Cognition DisordersNCT01536977
Phase II Early Behavioral Intervention in BMT w/ Sleep Disturbance-Assess QOL+Fatigue+Cognitive f(x)
A study testing quality-of-life assessment, questionnaire administration and management of therapy complications in people with Cognition Disorders and Fatigue, run by Stanford University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cognition Disorders, Fatigue, Sleep Disorders
- What is being tested?
- quality-of-life assessment, questionnaire administration and management of therapy complications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Cognition Disorders, Fatigue, Sleep Disorders, Other Complications of Bone Marrow Transplant
- Being tested
- quality-of-life assessment, questionnaire administration, management of therapy complications, cognitive assessment, educational intervention
- Keywords
- quality of life
- Medical subject headings
- Cognition Disorders, Fatigue, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
management of therapy complicationsBehavioural
Also called complications of therapy, management of
Undergo BBT-I
cognitive assessmentBehavioural
Ancillary studies
educational interventionBehavioural
Also called intervention, educational
Undergo BBT-I
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: quality-of-life assessment; Other: questionnaire administration; Behavioral: management of therapy complications; Behavioral: cognitive assessment; Behavioral: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks post-intervention
Secondary outcomes (4)
Influence of BBT-I on CRF and cognitive status in BMT recipients
Measured: Baseline
Influence of BBT-I on CRF and cognitive status in BMT recipients
Measured: 6 weeks post-intervention
Influence of BBT-I on QOL in BMT recipients
Measured: Baseline
Influence of BBT-I on QOL in BMT recipients
Measured: 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oxana Palesh, Stanford University
- Investigators
- Oxana Palesh, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536977
- Sponsor's protocol ID
- BMT242
- Other IDs
- NCI-2012-00117, SU-11112011-8650
- Status last verified
- May 2014
- First submitted
- 16 Feb 2012
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Behavioral Intervention in BMT Recipients With Sleep Disturbance: Assessing Its Impact on Quality of Life, Fatigue and Cognitive Function
- ClinicalTrials.gov ID
- NCT01536977
- Acronym / sponsor ID
- BMT242
- Conditions
- Cognition Disorders, Fatigue, Sleep Disorders, Other Complications of Bone Marrow Transplant
- Keywords
- quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (BBT-I) | Experimental | Other: quality-of-life assessment, Other: questionnaire administration, Behavioral: management of therapy complications, Behavioral: cognitive assessment, Behavioral: educational interventionPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Supportive care (BBT-I) |
| questionnaire administrationAncillary studies | Other | Supportive care (BBT-I) |
| management of therapy complicationsAlso: complications of therapy, management ofUndergo BBT-I | Behavioural | Supportive care (BBT-I) |
| cognitive assessmentAncillary studies | Behavioural | Supportive care (BBT-I) |
| educational interventionAlso: intervention, educationalUndergo BBT-I | Behavioural | Supportive care (BBT-I) |
Primary outcome
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.
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.
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oxana Palesh principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality-of-life assessment, questionnaire administration and management of therapy complications in people with Cognition Disorders and Fatigue, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.