Clinical trial NCT04736056: Mindfulness and CBT for Sleep
Official title: Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot
timeFrame: 12 weeks (post-intervention)
measure: Feasibility as Measured by Study Attrition at Post-intervention Follow-up
timeFrame: 12 weeks (post-intervention)
measure: Feasibility as Measured by Adherence to the Intervention
timeFrame: 12 weeks (post-intervention)
measure: Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)
timeFrame: 12 weeks (post-intervention)
measure: Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI)
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Secondary outcomes:
measure: Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI)
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Severity of Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Severity of Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Severity of Somatic Hyperarousal Symptoms
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Severity of Cognitive Hyperarousal Symptoms
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Describing
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Acting With Awareness
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Accepting/Non-judgement
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
measure: Self-efficacy for Symptom Management as Measured by the Self-Efficacy for Management Chronic Disease Scale (SEMCD)
timeFrame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Tamara J Somers, PhD
role: PRINCIPAL_INVESTIGATOR
References: