Mindfulness and CBT for Sleep

Study Overview
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Brief Summary
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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.

Official Title
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Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Behavioral: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills<br>Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+) The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes. | Behavioral: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills<br>* Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by study accrual | Treatment feasibility will be shown by meeting targeted study accrual (N = 30 for single-arm pilot). | 12 weeks (post-intervention) | 
| Feasibility as measured by study attrition | Treatment feasibility will be shown by no more than 20% study attrition. | 12 weeks (post-intervention) | 
| Feasibility as measured by adherence | Adherence will be indicated by at least 80% of study sessions completed. | 12 weeks (post-intervention) | 
| Acceptability as measured by the Client Satisfaction Questionnaire (CSQ) | Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ. | 12 weeks (post-intervention) | 
| Change in insomnia symptoms | Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue | Fatigue symptoms will be assessed using the 11-item Fatigue Symptom Inventory (FSI). | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 
| Change in pain | Pain symptoms will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF). | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 
| Change in anxiety and depression | Anxiety and depressive symptoms will be measured using the 14-item Hospital Anxiety and Depression Scale (HADS). | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 
| Change in hyperarousal | Hyperarousal symptoms will be measured using the 16-item Pre-Sleep Arousal Scale (PSAS). | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 
| Change in mindfulness | Mindfulness skills will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 
| Change in self-efficacy for symptom management | Self-efficacy for symptom management will be measured using the Self-Efficacy for Management Chronic Disease Scale. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |