Mindfulness Intervention for Blood Cancers

Overseen By Hannah M Fisher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Schizophrenia, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness program, Nite2Day+, designed to help individuals with blood cancers manage sleep problems, fatigue, stress, and pain during and after hospital treatment. Participants will either use a mobile app featuring mindfulness exercises and sleep tips or receive standard care. After hospital discharge, those in the mindfulness group will also participate in video sessions with a therapist to learn new strategies. Individuals with acute or recurring blood cancers who have experienced significant sleep issues and are undergoing at least a week of hospital treatment may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative strategies for improving quality of life during and after treatment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that all participants will continue to receive their usual medical care, which suggests you may not need to stop your current medications.

What prior data suggests that this mindfulness intervention is safe for patients with hematologic cancer?

Research shows that mindfulness programs like Nite2Day+ are usually easy for people to handle. In past studies, mindfulness therapies have helped with sleep problems and symptoms like tiredness and stress without causing major side effects. These treatments use methods like meditation and sleep education, which are safe and non-invasive. While the Nite2Day+ program is still being tested, similar mindfulness programs have shown safety in other studies. Participants in these studies have experienced few, if any, negative effects while using these types of therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nite2Day+ treatment because it provides a unique, holistic approach to improving sleep quality for blood cancer patients during their hospital stay. Unlike traditional medication-based treatments for insomnia, which often involve sedatives or sleep aids, Nite2Day+ utilizes a self-paced mobile app to deliver mindfulness-based interventions. This method includes meditations and sleep education specifically tailored for the inpatient setting, as well as a therapist-led Zoom protocol for continued support after discharge. By focusing on non-pharmacological strategies like mindfulness meditation and behavioral techniques, Nite2Day+ aims to enhance sleep without the side effects associated with traditional sleep medications.

What evidence suggests that the Nite2Day+ mindfulness intervention is effective for managing sleep disturbance and symptoms in patients with blood cancers?

Research has shown that mindfulness-based therapies, such as Nite2Day+, can improve sleep quality and reduce symptoms like tiredness, stress, and pain in individuals with blood-related cancers. In this trial, participants in the Nite2Day+ arm will engage in mindfulness practices that promote better sleep by teaching relaxation and coping strategies. Patients have experienced improvements in insomnia and related symptoms through mindfulness techniques. Early findings suggest that Nite2Day+ could effectively manage these symptoms by using methods like meditation and sleep education tailored for the hospital setting. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for hematologic cancer patients experiencing sleep disturbances and symptoms like fatigue, stress, and pain during/after inpatient treatment. Participants must be able to complete surveys and attend videoconference sessions post-treatment.

Inclusion Criteria

Ability to speak and read English, and intact hearing and vision

I am over 18 years old.

I have been diagnosed with a specific type of blood cancer.

Exclusion Criteria

Reported or suspected cognitive impairment, confirmed via Folstein Mini-Mental Status Exam less than 25

Serious psychiatric conditions (e.g., schizophrenia, suicidal intent) or medical conditions (e.g., seizure disorder, narcolepsy) indicated by medical chart, oncologist, or other provider

Expected survival of less than 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Treatment

Participants use a mobile app to access mindfulness meditations, sleep education videos, and strategies to improve sleep quality during inpatient treatment

4 weeks

Inpatient stay

Post-Inpatient Treatment

Participants complete 6 videoconference sessions with a therapist to learn mindfulness and coping strategies for sleep disturbance and symptoms

8 weeks

6 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up surveys at discharge, 8 weeks, and 12 weeks post-discharge

4 weeks

3 follow-up surveys

What Are the Treatments Tested in This Trial?

Interventions

• Nite2Day+

Trial Overview The study tests Nite2Day+, a mindfulness intervention using a mobile app with meditations, sleep education videos, and strategies to improve sleep. It includes six videoconference sessions after hospital discharge for coping strategies.

How Is the Trial Designed?

Group I: Nite2Day+ Experimental Treatment 1 Intervention

During inpatient treatment, Nite2Day+ will be delivered via a self-paced mobile app. Participants will use the app to access: 1) mindfulness meditations (e.g., Body Scan, 3-Minute Mini-Meditation) from Mindfulness Based Therapy for Insomnia (MBTI); 2) brief, 3-5 minute sleep education videos (i.e., 3-P Model of Insomnia, sleep hygiene, sleep drive, circadian rhythm) specifically tailored to the inpatient setting; and 3) brief, 3-5 minute videos teaching behavioral strategies (e.g., stimulus control, daytime activity, light exposure, communication with medical team) to improve sleep quality in the hospital. After inpatient treatment, Nite2Day+ will deliver a six session (45-60 minutes), therapist-led, Zoom protocol. Participants will learn new mindfulness-based sleep strategies (e.g., sleep consolidation, sleep reconditioning), meditations (e.g., Sitting Meditation), and behavioral symptom coping skills.

Group II: Usual Care Active Control 1 Intervention

Participants will receive written materials describing free services (e.g., legal and financial assistance, counseling) available through the Duke Cancer Patient Support Program.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Mindfulness-based stress reduction significantly improved subjective sleep parameters in patients with insomnia related to cervical cancer, showing benefits like reduced total wake time and increased total sleep time after an 8-week program.

However, while subjective improvements were noted, objective sleep measurements (polysomnography data) did not show significant changes, indicating that the benefits may not translate to measurable sleep quality improvements over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of mindfulness-based stress reduction for insomnia secondary to cervical cancer: Sleep effects. Zhang, H., Li, Y., Li, M., et al.[2020]

Participation in an 8-week mindfulness-based stress reduction (MBSR) program significantly improved quality of life, reduced stress symptoms, and enhanced sleep quality in 59 cancer patients (49 with breast cancer and 10 with prostate cancer).

The study also revealed changes in cytokine production, indicating a shift in immune response, with increased IL-4 and decreased IFN-gamma and IL-10, suggesting a move towards a healthier immune profile associated with reduced depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Carlson, LE., Speca, M., Patel, KD., et al.[2023]

Mindfulness-based therapy (MBT) significantly reduces anxiety, depression, fear of recurrence, and fatigue in breast cancer patients, based on a meta-analysis of seven studies involving 951 participants.

MBT also improves emotional well-being, physical function, and physical health in these patients, suggesting it could be a valuable complementary treatment alongside standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. Zhang, J., Xu, R., Wang, B., et al.[2022]

Mindfulness-based interventions (MBIs) have been shown to significantly reduce psychological distress, sleep disturbances, and fatigue in cancer patients, while also promoting personal growth in quality of life and spirituality.

There is emerging evidence that MBIs may positively influence biological markers related to immune function and stress regulation, although it is still uncertain if these changes lead to meaningful health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. Rouleau, CR., Garland, SN., Carlson, LE.[2020]

An 8-week mindfulness-based cognitive therapy (MBCT) program significantly reduced symptoms of depression and anxiety in 16 cancer survivors and their carers, with effects lasting up to 3 months after the intervention.

Increased mindfulness was correlated with decreased depression and anxiety scores, indicating that the MBCT program not only helps alleviate distress but also enhances mindfulness among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: an efficacious community-based group intervention for depression and anxiety in a sample of cancer patients. Sharplin, GR., Jones, SB., Hancock, B., et al.[2020]

Mindfulness-based stress reduction (MBSR) shows promising psychological benefits for cancer patients, as indicated by various instruments measuring its impact, although the effectiveness of these instruments varies.

The review highlights the need for more rigorous intervention studies on MBSR in cancer care to better understand its benefits and to refine the tools used to measure its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. Matchim, Y., Armer, JM.[2007]

An 8-week Mindfulness-Based Stress Reduction (MBSR) program significantly improved sleep quality in 63 cancer patients, with overall sleep disturbance reduced (p < .001).

Participants also experienced significant reductions in stress, mood disturbance, and fatigue, suggesting that MBSR can enhance the overall quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Carlson, LE., Garland, SN.[2018]

Mindfulness-based interventions (MBI) significantly improved sleep quality in cancer patients, with a moderate effect size (SMD = 0.37) based on a meta-analysis of 14 studies involving 1659 participants.

While MBI showed potential in reducing benzodiazepine (BZDs) use, the evidence was limited, with only three studies reporting this outcome, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based intervention on sleep disturbance and benzodiazepine hypnotics use in patients hospitalized with cancer: A systematic review and meta-analysis. Yang, B., Nie, Q., Yang, Y.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06532773

Mindfulness Intervention for Sleep Disturbance and ... This study is being done to test a mindfulness intervention for sleep disturbance and symptom management in patients with hematologic cancer during and after ...

2. withpower.com withpower.com/trial/phase-parasomnias-6-2025-f2eac

Mindfulness Intervention for Blood Cancers What data supports the effectiveness of the treatment Nite2Day+ for blood cancers? Research shows that mindfulness-based therapies can improve quality of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11365809/

Mindful Night-to-Day: A Pilot Feasibility Trial of a ... There is no mindfulness-based intervention for hematologic cancer patients that systematically addresses insomnia, as well as fatigue, pain, and ...

4. reporter.nih.gov reporter.nih.gov/project-details/10982416

Mindfulness Intervention for Sleep Disturbance and Symptom ... Hematologic cancer patients (N=60) reporting insomnia symptoms during hospitalization will be randomized (1:1) to Nite2Day+ or Usual Care. Nite2Day+ will be ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-04327

A Mindfulness-based Intervention for the Improvement of ... This clinical trial refines and tests the MBTI+ intervention for the reduction of treatment-related symptoms in patients with hematologic cancers. Eligibility ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04736056?keyword=%22Malignancy%22

San Mateo Clinical Trial Mindfulness and CBT for Sleep Patients with hematologic cancer frequently report significant difficulties with sleep in the months after discharge from inpatient chemotherapy.