N/A N=57 Treatment

Mindfulness and CBT for Sleep

Hematologic Malignancy

Bottom Line

View on ClinicalTrials.gov: NCT04736056 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot — 32 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot	32	—
PRIMARY Feasibility as Measured by Study Attrition at Post-intervention Follow-up	8.10	—
PRIMARY Feasibility as Measured by Adherence to the Intervention	83.80	—
PRIMARY Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)	29	—
PRIMARY Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI)	13.45; 6.26; 6.07	—
SECONDARY Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)	4.48; 3.69; 4.06	—
SECONDARY Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI)	4.18; 2.70; 3.09	—
SECONDARY Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)	2.59; 2.13; 1.79	—
SECONDARY Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)	3.35; 2.57; 1.85	—
SECONDARY Severity of Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)	6.65; 5.55; 5.47	—
SECONDARY Severity of Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)	6.61; 5.74; 5.20	—
SECONDARY Severity of Somatic Hyperarousal Symptoms	14.42; 11.65; 11.90	—
SECONDARY Severity of Cognitive Hyperarousal Symptoms	18.61; 15.13; 15.40	—
SECONDARY Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing	36.29; 39.23; 39.37	—
SECONDARY Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Describing	28.74; 28.74; 29.70	—
SECONDARY Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Acting With Awareness	32.32; 32.77; 31.57	—
SECONDARY Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Accepting/Non-judgement	32.00; 34.29; 33.77	—
SECONDARY Self-efficacy for Symptom Management as Measured by the Self-Efficacy for Management Chronic Disease Scale (SEMCD)	6.05; 6.88; 6.90	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04736056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.