Meditation Program for Cancer Patients and Caregivers

Overseen By Kathrin Milbury, MD,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive deficits, Pregnant patients, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two supportive care programs might enhance the mental health and quality of life for cancer patients and their family caregivers. Participants will either join a meditation program (known as Mindfulness Meditation or Meditation Therapy) or engage in discussion sessions with a counselor. This trial targets individuals diagnosed with stage IV cancer (advanced cancer that has spread to other parts of the body) who haven't experienced worsening symptoms in the past three months. A family caregiver willing to participate must also be involved. Either the patient or caregiver should currently experience significant distress, as measured by a common distress screening tool. As an unphased trial, this study offers a unique opportunity to contribute to understanding supportive care's impact on mental health and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on supportive care programs, so it's unlikely that medication changes are required, but you should confirm with the trial coordinators.

What prior data suggests that this meditation program is safe for cancer patients and caregivers?

Research has shown that mindfulness meditation can safely and effectively support cancer patients and their caregivers. In one study, 89 cancer patients who participated in a mindfulness meditation program experienced significant reductions in mood issues and stress, indicating that the program is generally well-received and carries minimal risk. Another study found that meditation can improve the overall quality of life for cancer patients, with benefits lasting for months. Additionally, just one meditation class provided symptom relief for both patients and caregivers. These studies highlight the safety and potential benefits of meditation for improving well-being without serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this meditation program for cancer patients and caregivers because it offers a holistic approach that complements traditional medical treatments like chemotherapy and radiation. Unlike standard care, which primarily focuses on the physical aspects of cancer, this program emphasizes mental and emotional well-being by incorporating family discussions and meditation sessions. The unique feature of this program is its family-centric approach, where participants engage in online sessions together, fostering a supportive environment that can enhance coping mechanisms and potentially improve overall quality of life.

What evidence suggests that this meditation program is effective for cancer patients and caregivers?

Research has shown that meditation can greatly benefit cancer patients. In one study, a 7-week mindfulness meditation program significantly reduced mood problems and stress for 89 cancer patients receiving outpatient care. Another study found that meditation improved mindfulness, social support, well-being, and spirituality among cancer patients. A review of several studies also demonstrated that online mindfulness programs reduced psychological issues like depression in cancer survivors. In this trial, participants in the Attention Control arm will join a meditation program, which might enhance the mental health and quality of life for cancer patients and their families. ^{2 3 6 7 8}

Who Is on the Research Team?

Kathrin Milbury, MD,PHD

Principal Investigator

MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults with stage IV breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer who've had no disease progression for at least 3 months. They must have a caregiver willing to join the study and both should be able to understand English or Spanish. Participants need an ECOG performance status of ≤2 and a distress score ≥4.

Inclusion Criteria

Both patient and caregiver must be able to provide informed consent

I am able to care for myself and perform daily activities.

Have a family caregiver willing to participate

Exclusion Criteria

Pregnant patients

I am under 18 years old.

Have cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Behavioral Intervention

Participants will take part in a discussion program with 4 sessions over 4 weeks

4 weeks

4 sessions (virtual)

Attention Control

Participants will take part in a meditation program with up to 4 sessions

4 weeks

4 sessions (virtual)

Follow-up

Participants are monitored for psychological wellbeing and quality of life

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Meditation Program

Trial Overview

The study examines the impact of two different supportive care programs on psychological wellbeing and quality of life in patients with advanced cancer and their caregivers. It involves a meditation program designed to help manage psycho-spiritual aspects related to cancer.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

All participants will receive cancer treatment per usual care (UC).

Group II: Behavioral Intervention (FFM Program) Experimental Treatment 1 Intervention

Participants will take part in a discussion program. Participants will be asked to complete 4 discussion sessions with a trained counselor over a course of a 4 week period. Participants should attend each session together as a family.

Group III: Attention Control Experimental Treatment 1 Intervention

Participants will take part in a meditation program. As part of this program, participants will complete up to 4 meditation sessions with a trained counselor. Participants should attend each session together as a family. All sessions will be online by videoconference using Zoom.

Meditation Program is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Meditation Program for:

• Anxiety
• Depression
• Stress Management
• Pain Management
• Quality of Life Improvement

Approved in European Union as Mindfulness Meditation for:

• Anxiety Disorders
• Depressive Disorders
• Chronic Pain Management
• Stress Reduction

Approved in Canada as Meditation Therapy for:

• Mental Health Support
• Palliative Care
• Symptom Management
• Well-being Enhancement

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study involving 172 women with early-stage breast cancer, an 8-week mindfulness-based stress-reduction (MBSR) program significantly improved quality of life and coping strategies compared to a nutrition education program and usual supportive care.

The benefits of MBSR included reductions in depression, anxiety, and emotional distress, although these improvements tended to decline over time, suggesting that MBSR could be a valuable complementary therapy in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial. Henderson, VP., Clemow, L., Massion, AO., et al.[2022]

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]

The Mindfulness Meditation program significantly reduced perceived stress, emotional coping, salivary cortisol levels, and psychological stress responses in 50 breast cancer patients over 8 weeks, compared to a control group.

This program is an effective nursing intervention for managing stress in breast cancer patients, although it did not show significant differences in problem-focused coping strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of Mindfulness Meditation program on perceived stress, ways of coping, and stress response in breast cancer patients]. Kang, G., Oh, S.[2015]

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]

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]

There has been a growing interest among cancer patients in using complementary therapies, like meditation, to help manage the psychological and social challenges of their illness.

The article highlights the need for a tailored meditation program specifically for cancer patients, as existing programs for other health issues do not adequately address their unique needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation as a complementary therapy in cancer. Tacón, AM.[2019]

The mindfulness-based cancer recovery (MBCR) program significantly improved psychological well-being and quality of life in 101 cancer patients after an 8-week intervention, with benefits including reduced stress and depression, and increased optimism and vitality.

These positive effects were sustained for at least 6 months after the intervention, indicating that MBCR is an effective long-term psychosocial treatment for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of mindfulness-based cancer recovery (MBCR) program among Hungarian cancer patients]. Rohánszky, M., Berényi, K., Fridrik, D., et al.[2017]

Participation in a 7-week mindfulness meditation program significantly reduced mood disturbance and stress symptoms in 89 cancer outpatients, with improvements lasting for at least 6 months after the program ended.

Higher initial mood disturbance and more daily meditation practice were linked to greater improvements, indicating that mindfulness meditation can be a beneficial intervention for managing stress in cancer patients across various demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up. Carlson, LE., Ursuliak, Z., Goodey, E., et al.[2019]

In a study involving 104 cancer patients, both mindfulness-based stress reduction (MBSR) and healing through the creative arts (HA) programs significantly improved post-traumatic growth over time.

Participants in the MBSR program showed greater improvements in spirituality, anxiety, anger, overall stress symptoms, and mood disturbance compared to those in the HA program, suggesting MBSR may be more effective for emotional well-being in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-randomized comparison of mindfulness-based stress reduction and healing arts programs for facilitating post-traumatic growth and spirituality in cancer outpatients. Garland, SN., Carlson, LE., Cook, S., et al.[2022]

A 6-week mindfulness-based stress reduction program (MBSR-C) significantly improved stress and anxiety levels in advanced-stage cancer patients, indicating its potential efficacy in managing psychological symptoms.

Both patients and caregivers experienced reductions in cortisol levels after the program, suggesting that MBSR-C may help lower physiological stress markers, although improvements in caregivers' quality of life were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study evaluating the effect of mindfulness-based stress reduction on psychological status, physical status, salivary cortisol, and interleukin-6 among advanced-stage cancer patients and their caregivers. Lengacher, CA., Kip, KE., Barta, M., et al.[2022]

Five studies on meditation interventions for cancer patients showed that while the design did not isolate meditation's effects, four of them reported significant improvements in symptoms of depression and anxiety.

There is a growing recognition that meditation may enhance spiritual well-being, which could positively impact the quality of life for cancer patients, but more rigorously designed studies are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Does meditation improve the quality of life for patients living with cancer?]. Lamanque, P., Daneault, S.[2018]

Citations

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