60 Participants Needed

Mindfulness Intervention for Blood Cancers

HM
Overseen ByHannah M Fisher, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Nite2Day+ for blood cancers?

Research shows that mindfulness-based therapies can improve quality of life, mood, and reduce stress in cancer patients, including those with breast and prostate cancer. These benefits suggest that similar mindfulness interventions, like Nite2Day+, might also help patients with blood cancers.12345

Is mindfulness intervention safe for people with cancer?

Research on mindfulness-based interventions for cancer patients suggests they are generally safe and can help reduce stress, improve sleep, and enhance quality of life. While these studies focus on different types of cancer, they indicate that mindfulness practices are well-tolerated and do not pose significant safety concerns.13678

How does the treatment Nite2Day+ differ from other treatments for blood cancers?

Nite2Day+ is unique because it incorporates mindfulness-based interventions, which have been shown to improve sleep and reduce stress in cancer patients, unlike traditional treatments that primarily focus on medication or chemotherapy.138910

What is the purpose of this trial?

People with hematologic cancer often have sleep disturbance and symptoms of fatigue, stress, and pain. This study is being done to test a mindfulness intervention for sleep disturbance and symptom management in patients with hematologic cancer during and after inpatient treatment (Nite2Day+). Participants will complete a baseline survey online, using a mobile application, or paper/pencil. Once the baseline survey is complete, participants will be randomized (like a flip of a coin) to receive Nite2Day+ or Standard Care. Nite2Day+ will include activities during and after inpatient treatment. During inpatient treatment, participants will use a mobile app to access: 1) mindfulness meditations, 2) brief sleep education videos, and 3) brief videos teaching strategies to improve sleep quality in the hospital. After inpatient treatment, participants will complete 6, videoconference sessions (45-60 minutes) with a trained therapist to learn mindfulness and behavioral coping strategies to self-manage nighttime sleep disturbance and daytime symptoms of fatigue, stress, and pain. Three follow-up surveys will occur at hospital discharge, and approximately 8, and 12 weeks after hospital discharge. Participants randomized to Nite2Day+ will be given the option to complete an exit interview to provide feedback on the Nite2Day+ program. Participants randomized to Standard Care will only complete the four surveys. All participants will continue to receive their usual medical care. The total study duration is about 16 weeks.

Eligibility Criteria

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.
See 2 more

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Nite2Day+Experimental Treatment1 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 CareActive Control1 Intervention
Participants will receive written materials describing free services (e.g., legal and financial assistance, counseling) available through the Duke Cancer Patient Support Program.

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
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]
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.
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]

References

Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. [2022]
Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. [2023]
Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance. [2022]
Mindfulness-based cognitive therapy: an efficacious community-based group intervention for depression and anxiety in a sample of cancer patients. [2020]
Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. [2007]
Impact of Mindfulness-Based Stress Reduction (MBSR) on attention, rumination and resting blood pressure in women with cancer: a waitlist-controlled study. [2022]
The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. [2020]
A randomized controlled trial of mindfulness-based stress reduction for insomnia secondary to cervical cancer: Sleep effects. [2020]
The effects of mindfulness-based intervention on sleep disturbance and benzodiazepine hypnotics use in patients hospitalized with cancer: A systematic review and meta-analysis. [2021]
Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. [2018]
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