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

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 low grade glioma or tumors that have spread to the brain and their partners. A couple-based mind body program may help to improve spiritual well-being, sleep difficulties, depressive symptoms, and overall quality of life in patients with glioma or tumors that have spread to the brain and their partners.

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.

Is the Mind-Body Program safe for participants?

Mind-body interventions, like yoga, meditation, and relaxation therapies, have been studied in cancer patients and are generally considered safe. They can help reduce stress, anxiety, and improve quality of life, with no significant safety concerns reported in the studies. ^{1 2 3 4 5}

How is the Mind-Body Intervention Procedure treatment different from other treatments for brain tumor patients and their partners?

The Mind-Body Intervention Procedure is unique because it focuses on the emotional and social well-being of both brain tumor patients and their partners, using techniques like meditation to improve their overall quality of life. Unlike traditional medical treatments that target the tumor itself, this approach aims to enhance the couple's ability to cope with stress and maintain supportive relationships. ^{5 6 7 8 9}

What data supports the effectiveness of the Mind-Body Intervention Procedure treatment for brain tumor couples?

Research shows that mind-body interventions, like meditation and mindfulness, can help reduce stress and improve well-being in patients with brain tumors and their caregivers. A study on a couple-based meditation program found it feasible and potentially effective in improving symptoms and well-being. ^{1 6 8 10 11}

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

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

I regularly attend psychotherapy or a cancer support group.

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

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]

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]

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. England pubmed.ncbi.nlm.nih.gov

Guiding research in family care: a new approach to oncology caregiving. [2022]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Single-institution cross-sectional study to evaluate need for information and need for referral to psychooncology care in association with depression in brain tumor patients and their family caregivers. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of a Mindfulness Intervention on Hospitalized Patients With Hematologic Malignancies and Their Caregivers. [2021]

5. England 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A Nonrandomized Comparison Study of Self-Hypnosis, Yoga, and Cognitive-Behavioral Therapy to Reduce Emotional Distress in Breast Cancer Patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Mind-body interventions in oncology. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Mind-body therapies in integrative oncology. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Mind-body medicine and cancer. [2008]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Social relationships and relational pain in brain tumor patients and their partners. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Spouse Caregivers' Experiences of Suffering in Relation to Care for a Partner With Brain Tumor: A Qualitative Study. [2022]