Mindfulness and CBT for Sleep

Hematologic Malignancy Clinical Trial

Official title:

Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736056
• Other study ID #: Pro00107338
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

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)