A Mindfulness-based Intervention for the Improvement of Treatment-Related Symptoms in Patients with Hematologic Cancer

Status: closed to accrual

This clinical trial evaluates a mindfulness-based therapy for insomnia (MBTI+) intervention for the improvement of treatment-related symptoms like insomnia, pain, and distress in patients who received treatment for a blood (hematologic) cancer. Patients who receive treatment for a hematologic cancer are often left with side effects like sleep disturbances, fatigue, pain, and distress. The MBTI+ intervention uses sleep restriction and stimulus control with mindfulness principles and exercises like meditation to reduce these treatment-related symptoms. This clinical trial refines and tests the MBTI+ intervention for the reduction of treatment-related symptoms in patients with hematologic cancers.

Inclusion Criteria

ELIGIBILITY CRITERIA FOR PATIENTS IN PHASE I AND PHASE II:
An initial or recurrent/relapse diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, multiple myeloma, myelodysplastic syndrome
Within 8 weeks of discharge home after inpatient chemotherapy or chimeric antigen receptor T-cell (CAR-T) therapy
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 or 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
Age of 18 years or older
PROVIDERS IN PHASE I:
Healthcare professional (e.g., oncologist, physician assistant, nurse) working within the Division of Hematological Malignancies and Cellular Therapy at Duke University Medical Center

Exclusion Criteria

EXCLUSION CRITERIA FOR PATIENTS IN PHASE I AND PHASE II:
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 OBJECTIVES:

I. To develop and refine the MBTI+ protocol for individual, home-based delivery to hematologic cancer patients reporting insomnia, fatigue, pain, and distress following discharge from any cycle of inpatient chemotherapy treatment.

II. To assess the feasibility, acceptability, and examine pre- to post-intervention outcomes of MBTI+.

OUTLINE:

PART I: Patients and providers attend focus groups over 45-75 minutes and complete a survey over 15 minutes in support of intervention refinement.

PART II: Patients receive the mindfulness-based therapy for insomnia intervention over 60-75 minute weekly for 6 sessions.

After completion of study intervention, patients are followed up at 1 month.

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A Mindfulness-based Intervention for the Improvement of Treatment-Related Symptoms in Patients with Hematologic Cancer

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Eligibility Criteria

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Trial Objectives and Outline

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