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NCT Number: NCT04736056

Mindfulness and CBT for Sleep

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.

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Key information

Conditions

Hematologic Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills

Behavioral

Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.

Primary outcomes

  1. Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot

    Time frame: 12 weeks (post-intervention)

    Treatment feasibility will be indicated by meeting target study accrual (i.e., 30 participants consented and enrolled for single-arm pilot).

  2. Feasibility as Measured by Study Attrition at Post-intervention Follow-up

    Time frame: 12 weeks (post-intervention)

    Treatment feasibility will be indicated by less than or equal to 20% study attrition at post-intervention follow-up.

  3. Feasibility as Measured by Adherence to the Intervention

    Time frame: 12 weeks (post-intervention)

    Adherence will be indicated by at least 80% of the participants completing all 6 intervention sessions.

  4. Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)

    Time frame: 12 weeks (post-intervention)

    Acceptability will be indicated by at least 80% of participants who completed the intervention protocol reporting satisfaction with the protocol on the CSQ (i.e., mean of at least 3 out of 4). The CSQ is a 10 item self-report measure with item responses ranging from 1 to 4, with higher scores indicating greater satisfaction. All 10 items were averaged to obtain a mean score (range: 1 - 4). The number of participants with a mean CSQ score of at least 3 out of 4 was tabulated and then converted to a percentage of patients.

  5. Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI)

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Scores on the ISI range from 0 to 28 with higher scores indicating more severe insomnia symptoms.

Secondary outcomes

  1. Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Fatigue symptoms will be assessed using the 11-item Fatigue Symptom Inventory (FSI). Four items measure fatigue severity. Seven items measure fatigue interference. Scores on the FSI for fatigue severity and interference range from 0 to 10 with higher scores indicating higher fatigue severity and interference.

  2. Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI)

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Fatigue symptoms will be assessed using the 11-item Fatigue Symptom Inventory (FSI). Four items measure fatigue severity. Seven items measure fatigue interference. Scores on the FSI for fatigue severity and interference range from 0 to 10 with higher scores indicating higher fatigue severity and interference.

  3. Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Pain symptoms will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF). Four items measure pain severity. Scores on the BPI-SF for pain severity range from 0 to 10 with higher scores indicating higher pain severity.

  4. Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Pain symptoms will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF). Seven items measure pain interference. Scores on the BPI-SF for pain interference range from 0 to 10 with higher scores indicating higher pain interference.

  5. Severity of Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Anxiety symptoms will be measured using the 14-item Hospital Anxiety and Depression Scale (HADS). Seven items measure severity of anxiety symptoms. Scores for anxiety symptom severity range from 0 to 21 with higher scores indicating more severe anxiety.

  6. Severity of Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Depressive symptoms will be measured using the 14-item Hospital Anxiety and Depression Scale (HADS). Seven items measure severity of depressive symptoms. Scores for depressive symptom severity range from 0 to 21 with higher scores indicating more severe depressive symptoms.

  7. Severity of Somatic Hyperarousal Symptoms

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Hyperarousal symptoms will be measured using the 16-item Pre-Sleep Arousal Scale (PSAS). Eight items measure severity of somatic hyperarousal symptoms. Scores for somatic hyperarousal symptom severity range from 8 to 40 with higher scores indicating worse somatic hyperarousal severity.

  8. Severity of Cognitive Hyperarousal Symptoms

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Hyperarousal symptoms will be measured using the 16-item Pre-Sleep Arousal Scale (PSAS). Eight items measure severity of cognitive hyperarousal symptoms. Scores for cognitive hyperarousal symptom severity range from 8 to 40 with higher scores indicating worse cognitive hyperarousal severity.

  9. Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Observing (range: 12-60) is measured by 12 items. Higher scores indicate higher levels of observing skills.

  10. Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Describing

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Describing (range: 8-40) is measured by eight items. Higher scores indicate higher levels of describing skills.

  11. Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Acting With Awareness

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Acting with awareness (range: 10-50) is measured by ten items. Higher scores indicate higher levels of acting with awareness skills.

  12. Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Accepting/Non-judgement

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Accepting is measured by nine items (range: 9-45). Higher scores indicate higher levels of accepting skills.

  13. Self-efficacy for Symptom Management as Measured by the Self-Efficacy for Management Chronic Disease Scale (SEMCD)

    Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

    SEMCD scores range from 0 to 10 with higher scores indicating greater self-efficacy for symptom management.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2021
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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