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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04736056
Other study ID # Pro00107338
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date May 19, 2023

Study information

Verified date May 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date May 19, 2023
Est. primary completion date May 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.

Locations

Country Name City State
United States Duke Cancer Institute Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary Feasibility as measured by study attrition Treatment feasibility will be shown by no more than 20% study attrition. 12 weeks (post-intervention)
Primary Feasibility as measured by adherence Adherence will be indicated by at least 80% of study sessions completed. 12 weeks (post-intervention)
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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