Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot
研究概览
简要总结
Patients with hematologic cancer frequently report significant difficulties with sleep in the months after discharge from inpatient chemotherapy. Poor sleep quality can contribute to and perpetuate problems with daytime fatigue, pain, and distress that are common among patients with hematologic cancer. There is a need for behavioral interventions that address insomnia and daytime fatigue, pain, and distress once hematologic cancer patients have returned home after inpatient chemotherapy. Mindfulness-Based Therapy for Insomnia (MBTI) is a new approach to treating insomnia. This group-based intervention combines sleep restriction and stimulus control with mindfulness principles and exercises to reduce worry and promote positive responses to insomnia. To date, MBTI has not been applied to patients with hematologic cancer. If MBTI is to meet the needs of hematologic cancer patients, it must be adapted in several ways. First, because hematologic cancer patients are immunosuppressed, MBTI needs to be adapted for one-to-one delivery. Second, because hematologic cancer patients experience significant daytime fatigue, pain, and distress, MBTI needs to be adapted to include systematic training in coping skills for these symptoms. The investigators propose to develop and pilot test an adapted MBTI (MBTI+) protocol for hematologic cancer patients reporting insomnia, fatigue, pain, and/or distress after inpatient chemotherapy. The study will be conducted in two phases. In Phase I, the study team will use focus groups with hematologic cancer patients and hematology-oncology providers to guide development along with user testing with hematologic cancer patients reporting insomnia and daytime symptoms of fatigue, pain, and/or distress. Phase II will involve a small single-arm pilot to examine the feasibility, acceptability, and examine pre- to post-intervention primary (insomnia) and secondary (fatigue, pain, distress, mindfulness, self-efficacy) outcomes of the MBTI+ protocol. MBTI+ will consist of six, 60- to 75-minute therapy sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an initial or recurrent diagnosis of hematologic malignancy
- •within 8 weeks of discharge home after inpatient chemotherapy or CAR-T therapy
- •total score of 8 or greater on the Insomnia Severity Index (ISI)
- •score of 5 or greater on the MD Anderson Symptom Inventory Scale for "worst" fatigue, pain, or distress, and report that these symptoms interfered with at least two activities of living (i.e., general activity, mood, work) in the last week at 3 or greater on a 0="Did not interfere" to 10="Interfered completely" scale
- •ability to speak and read English, and hearing and vision that allows for completion of sessions and assessments
排除标准
- •reported or suspected cognitive impairment subsequently informed by a Folstein Mini-Mental Status Examination of <25
- •presence of a serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, treating oncologist or other medical provider that would contraindicate safe participation
- •expected survival of 6 months or less
结局指标
主要结局
Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot
时间窗: 12 weeks (post-intervention)
Treatment feasibility will be indicated by meeting target study accrual (i.e., 30 participants consented and enrolled for single-arm pilot).
Feasibility as Measured by Study Attrition at Post-intervention Follow-up
时间窗: 12 weeks (post-intervention)
Treatment feasibility will be indicated by less than or equal to 20% study attrition at post-intervention follow-up.
Feasibility as Measured by Adherence to the Intervention
时间窗: 12 weeks (post-intervention)
Adherence will be indicated by at least 80% of the participants completing all 6 intervention sessions.
Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)
时间窗: 12 weeks (post-intervention)
Acceptability will be indicated by at least 80% of participants who completed the intervention protocol reporting satisfaction with the protocol on the CSQ (i.e., mean of at least 3 out of 4). The CSQ is a 10 item self-report measure with item responses ranging from 1 to 4, with higher scores indicating greater satisfaction. All 10 items were averaged to obtain a mean score (range: 1 - 4). The number of participants with a mean CSQ score of at least 3 out of 4 was tabulated and then converted to a percentage of patients.
Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI)
时间窗: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Scores on the ISI range from 0 to 28 with higher scores indicating more severe insomnia symptoms.
次要结局
- Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI)(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Severity of Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Severity of Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Severity of Somatic Hyperarousal Symptoms(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Severity of Cognitive Hyperarousal Symptoms(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Describing(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Acting With Awareness(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Accepting/Non-judgement(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))
- Self-efficacy for Symptom Management as Measured by the Self-Efficacy for Management Chronic Disease Scale (SEMCD)(0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention))