Mindfulness-Based Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help women with breast cancer manage challenging symptoms such as insomnia, fatigue, stress, and pain. It tests a mindfulness-based therapy called Nite2Day, which teaches relaxation and coping techniques in six remote sessions. These sessions aim to improve sleep and daytime comfort. Women diagnosed with breast cancer in the past year who experience sleep issues might be suitable candidates. Participants can learn valuable skills and contribute to research that may benefit other cancer patients in the future. As an unphased trial, participants may gain personal benefits while advancing research for future cancer care.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on mindfulness and therapy sessions, so you might not need to change your medication routine, but it's best to confirm with the study team.
What prior data suggests that this mindfulness-based therapy is safe for women with breast cancer?
Research has shown that mindfulness-based therapy, combined with cognitive-behavioral techniques, is safe and can help manage symptoms in women with breast cancer. For example, one study found that this therapy improved sleep quality and reduced stress, anxiety, and depression in women. Another study showed that remotely delivered mindfulness therapy significantly reduced fatigue in cancer survivors. These studies reported no serious side effects, suggesting the treatment is well-tolerated. The therapies focus on teaching skills to manage sleep problems and daytime symptoms, which has helped many participants without causing harm.12345
Why are researchers excited about this trial?
Researchers are excited about Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills, known as Nite2Day, because it offers a non-pharmacological approach to managing insomnia in breast cancer patients. Unlike traditional treatments that often rely on medication, Nite2Day focuses on teaching mindfulness-based sleep strategies and behavioral symptom management techniques. This method empowers patients to manage their symptoms through mindfulness practices, potentially reducing side effects and improving overall well-being. By providing a structured, skill-based intervention over just six weeks, it aims to offer a sustainable and holistic alternative to medication-based therapies.
What evidence suggests that this mindfulness-based therapy is effective for managing insomnia and symptoms in breast cancer patients?
Research has shown that mindfulness-based therapies can assist people with breast cancer who experience sleep difficulties and other symptoms. One study found that about 60% of patients with moderate to severe insomnia improved to having little to no insomnia after treatment. These therapies have also enhanced sleep quality for cancer patients. Additionally, they help reduce stress, anxiety, and depression, which are common among breast cancer patients. This trial will evaluate the effectiveness of the Nite2Day intervention, which combines mindfulness-based sleep strategies with cognitive-behavioral symptom coping skills, to manage sleep issues and other daytime symptoms.36789
Who Is on the Research Team?
Hannah M Fisher, PhD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for women with stage 0-IV breast cancer diagnosed in the past year, who have at least mild insomnia. They should expect to live more than a year, be able to speak and read English, and have good hearing and vision.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants complete six weekly mindfulness-based insomnia and symptom management intervention sessions remotely
Follow-up
Participants are monitored for changes in symptoms and overall effectiveness of the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Trial Overview
The study tests a mindfulness-based therapy combined with cognitive-behavioral coping skills for managing insomnia and symptoms like fatigue, stress, and pain. It involves six remote sessions over Zoom or phone plus three short surveys.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (Nite2Day) The Nite2Day intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The Nite2Day intervention will consist of 6 weekly sessions that will between 45 and 60 minutes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Effects of mindfulness-based cognitive therapy on breast ...
We found that 59.6% of the MBCT-I group with moderate and severe insomnia improved to no insomnia and subclinical insomnia at T4 relative to T1, ...
Effects of mindfulness-based interventions (MBIs) on ...
MBIs significantly improved quality of sleep among patients with cancer. Clinicians should consider using MBIs as alternative complementary treatment.
An examination of the effectiveness of mindfulness ...
Based on the results of this study, it can be concluded that MICBT therapy is effective in reducing depression, anxiety, and stress and ...
The Effects of Mindfulness-Based Stress Reduction (MBSR ...
Results showed indications of a positive effect of MBSR(BC) on OSP at 12 weeks on sleep efficiency (78.2% MBSR(BC) group vs. 74.6% UC group, p=0.04), percent of ...
5.
bmcwomenshealth.biomedcentral.com
bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-023-02486-xImmediate impact of Mindfulness-Based Cognitive Therapy ...
Our study provides evidence that MBCT has benefits for patients with breast cancer in terms of alleviating anxiety, pain, and depression and ...
Adaptation and Pilot Testing of a Mindfulness-Based ...
This study is being done to test a mindfulness-based insomnia and symptom management intervention for women with breast cancer (Nite2Day). Participants will ...
Cognitive Behavioral Therapy for Insomnia, Mindfulness ...
Mindfulness based stress reduction in post-treatment breast cancer patients: an examination of symptoms and symptom clusters. J Behav Med ...
The mindfulness-based stress reduction program for ...
This study aims to evaluate the efficacy and effectiveness of a mindfulness-based stress reduction (MBSR) program in improving sleep in cancer survivors.
Benefits of Remote-Based Mindfulness on Physical Symptom ...
After remote-based mindfulness treatment, cancer survivors showed a significant reduction in fatigue (SMD −0.94; 95% CI: −1.56 to −0.33; P=.002) ...
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