Mind-Body Program for Brain Tumor Couples

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Psychotherapy, Cancer support group, Cognitive deficits

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

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a couple-based mind-body program can improve the quality of life for people with brain tumors and their partners. The program includes deep-breathing and meditation exercises, along with phone calls to support emotional and physical well-being. It is designed for patients who have recently started cancer treatment and have a partner willing to participate. Those experiencing sleep difficulties or feeling down due to a brain tumor diagnosis might find this trial beneficial. Participants must have internet access and be able to read and speak English. As an unphased trial, this study offers a unique opportunity to explore innovative support methods for enhancing well-being.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mind-body intervention procedure is safe?

Research shows that mind-body programs, like the one in this study, are generally safe for people with brain tumors. Studies have found that these programs can help reduce stress and anxiety without major safety issues. Previous research reported no serious side effects. Participants often experienced a better quality of life, including improved sleep and mood. This suggests that the mind-body program is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mind-Body Intervention for brain tumor patients and their partners because it offers a holistic approach that addresses both physical and emotional well-being. Unlike traditional treatments that focus solely on the physical aspects of brain tumors, this program integrates deep-breathing and meditation exercises, which can help manage stress and improve overall quality of life. By providing regular sessions and follow-up support through phone calls, this intervention promotes a supportive environment that can positively impact mood, relationships, and even work productivity. This comprehensive approach is what makes it stand out from conventional treatment options.

What evidence suggests that this mind-body program is effective for improving quality of life in brain tumor patients and their partners?

This trial will compare a mind-body intervention program with a waitlist control group for couples dealing with brain tumors. Studies have shown that mind-body programs, including meditation and deep-breathing exercises, can improve spiritual and emotional well-being. Early findings suggest they may also help with sleep problems and feelings of depression. One study found that these programs are feasible and may effectively enhance the overall quality of life for both patients and their partners. By focusing on relaxation and connection, these activities aim to support couples through their cancer journey. ^{1 4 5 6 7}

Who Is on the Research Team?

Kathrin Milbury

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for couples where one partner has a high or low grade glioma, or a tumor that has spread to the brain. The patient must have started cancer treatment within the last month and be fairly active (KPS of 80+). Both partners need to speak English, consent to participate, and have internet access.

Inclusion Criteria

Patients and partners must be able to provide informed consent

Patients and partners must have access to internet connectivity

I can carry out normal activities with minimal symptoms.

Exclusion Criteria

I regularly attend psychotherapy or a cancer support group.

Cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a couple-based mind-body program consisting of deep-breathing and meditation exercise sessions and weekly telephone calls for 6 weeks

6 weeks

4-5 sessions (in-person), 2 weekly calls (telephone)

Follow-up

Participants are monitored for quality of life outcomes and other measures after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Mind-Body Intervention Procedure

Trial Overview The study tests a couple-based mind-body program designed to improve spiritual, social, and physical well-being for patients with gliomas or brain metastases and their partners. It includes questionnaires, quality-of-life assessments, and mind-body intervention procedures.

How Is the Trial Designed?

Group I: Group I (CBMB program) Experimental Treatment 3 Interventions

Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life.

Group II: Group II (waitlist control) Active Control 2 Interventions

Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A couple-based meditation (CBM) program delivered via FaceTime was found to be feasible and acceptable for couples dealing with brain tumors, with 63% of participants completing all assessments.

Patients in the CBM group showed significant improvements in cognitive symptoms, general disease symptoms, relationship well-being, and compassion, indicating that the intervention may effectively enhance their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Couple-Based Meditation Intervention for Patients With Primary or Metastatic Brain Tumors and Their Partners: Results of a Pilot Randomized Controlled Trial. Milbury, K., Weathers, SP., Durrani, S., et al.[2023]

The study highlights the need to explore how stress responses in family caregivers of brain tumor patients can affect both their emotional and physical health, suggesting a connection between these aspects.

A systematic review of existing literature supports the use of a biobehavioral model to understand the interactions between emotional reactions and physical health changes in caregivers, paving the way for future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guiding research in family care: a new approach to oncology caregiving. Sherwood, PR., Given, BA., Donovan, H., et al.[2022]

This study aims to assess the feasibility of implementing dyadic yoga (DY) and caregiver yoga (CY) interventions for glioma patients and their caregivers, involving 75 participants over 15 sessions during 6 weeks of radiotherapy.

The primary goal is to determine if at least 50% of eligible dyads consent to participate and if 70% complete all assessments, which will help inform future larger trials on the impact of yoga on symptoms and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A research protocol for a pilot, randomized controlled trial designed to examine the feasibility of a dyadic versus individual yoga program for family caregivers of glioma patients undergoing radiotherapy. Milbury, K., Li, J., Weathers, SP., et al.[2023]

Mind-body interventions like hypnosis and imagery/relaxation have been shown to effectively control pain and reduce anxiety in cancer patients, enhancing their overall treatment experience.

Yoga and meditation are supported by randomized controlled trials for improving quality of life, mood, and sleep in cancer patients, highlighting the importance of these therapies in managing the emotional and physical challenges of cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body interventions in oncology. Carlson, LE., Bultz, BD.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03244995

NCT03244995 | Mind-Body Intervention in Glioma Couples This trial studies how well a couple-based mind body program works in improving spiritual, psychosocial, and physical quality of life in patients with high or ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11816621/

Online Couple-Based Meditation Intervention for Patients ... We sought to examine the feasibility and preliminary efficacy of a couple-based meditation (CBM) program targeting symptom and well-being outcomes.

3. withpower.com withpower.com/trial/phase-glioblastoma-7-2017-65993

Mind-Body Program for Brain Tumor Couples A study on a couple-based meditation program found it feasible and potentially effective in improving symptoms and well-being. Show more ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0885392417306929

Pilot Testing of a Brief Couple-Based Mind-Body ... Newly recruited couples completed measures of depressive symptoms, cancer distress, spiritual well-being, and sleep disturbances before and after the ...

5. jpsmjournal.com jpsmjournal.com/article/S0885-3924(20)30088-9/pdf

Online Couple-Based Meditation Intervention for Patients ... Thus, we sought to examine the feasibility and preliminary efficacy of a couple-based meditation (CBM) program targeting symptom and well-being ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0885392420300889

Online Couple-Based Meditation Intervention for Patients ... We pilot tested a four-session dyadic program that integrates meditation training with emotional disclosure exercises.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11445902/

Landscape and impact of mind-body, cognitive-behavioral ... Findings suggest that mind-body and physical activity interventions can improve both physical and psychological health for patients with brain tumors, though ...