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Mind-Body Program for Brain Tumor Couples
N/A
Waitlist Available
Led By Kathrin Milbury
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status (KPS) of 80 or above
Patients with a diagnosis of HGG or low grade glioma (LGG), based on radiographic or pathologic diagnosis of grade III or IV listed in the medical records, or patients with a malignancy that has metastasized to the brain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months after completion of study
Awards & highlights
Study Summary
This trial tests a mind-body program to improve spiritual, psychosocial, and physical quality of life for people with brain tumors and their partners.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is not a drug trial but rather an intervention involving mental and emotional support strategies, there are no typical medication side effects; however participants may experience emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out normal activities with minimal symptoms.
Select...
I have a high-grade glioma, low-grade glioma, or cancer that has spread to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months after completion of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months after completion of study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CBMB program efficacy
Feasibility of CBMB program as determined by acceptability
Feasibility of CBMB program as determined by adherence
+2 moreOther outcome measures
CBMB program efficacy on quality of life (QOL) outcomes
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (CBMB program)Experimental Treatment3 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 Control2 Interventions
Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,707 Total Patients Enrolled
42 Trials studying Glioblastoma
1,895 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,079 Total Patients Enrolled
322 Trials studying Glioblastoma
23,041 Patients Enrolled for Glioblastoma
Kathrin MilburyPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
1,877 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can carry out normal activities with minimal symptoms.I have a partner who is willing to join the study with me.I started or had cancer treatment within the last month.I have a high-grade glioma, low-grade glioma, or cancer that has spread to my brain.I regularly attend psychotherapy or a cancer support group.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (CBMB program)
- Group 2: Group II (waitlist control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment have room for new participants to join?
"The clinical trial in question is not currently enrolling participants. This study, which was initially posted on August 6th 2017 and last updated June 8th 2023, has since concluded recruitment; nevertheless, there are 3194 other trials recruiting patients presently."
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