Early Behavioral Intervention in BMT Recipients With Sleep Disturbance: Assessing Its Impact on Quality of Life, Fatigue and Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Supportive care (BBT-I)
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.
干预措施: quality-of-life assessment (Other)
Supportive care (BBT-I)
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.
干预措施: questionnaire administration (Other)
Supportive care (BBT-I)
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.
干预措施: management of therapy complications (Behavioral)
Supportive care (BBT-I)
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.
干预措施: cognitive assessment (Behavioral)
Supportive care (BBT-I)
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.
干预措施: educational intervention (Behavioral)
结局指标
主要结局
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
时间窗: 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
时间窗: 6 weeks post-intervention
The analysis will use longitudinal models with time as predictor and insomnia severity (ISI total score) as the dependent variable.
次要结局
- 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(6 weeks post-intervention)
- Influence of BBT-I on CRF and cognitive status in BMT recipients(Baseline)
- Influence of BBT-I on QOL in BMT recipients(Baseline)
研究者
Oxana Palesh
Assistant Professor of Psychiatry and Behavioral Science
Stanford University