GlioblastomaNCT03244995
Mind-Body Intervention in Glioma Couples
A study testing Mind-Body Intervention Procedure, Quality-of-Life Assessment and Questionnaire Administration in people with Glioblastoma and Low Grade Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma, Low Grade Glioma, Malignant Glioma
- What is being tested?
- Mind-Body Intervention Procedure, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2017to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENT ONLY: 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
- PATIENT ONLY: Patients must be within 1 month of initiating or having undergone any type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy)
- PATIENT ONLY: Karnofsky performance status (KPS) of 80 or above
- PATIENT ONLY: Having a spouse/romantic partner (including same-sex) and who is willing to participate
- PATIENT \& PARTNER: Able to read and speak English
- PATIENT \& PARTNER: Able to provide informed consent
- PATIENT \& PARTNER: Have access to internet connectivity
Who cannot join
- PATIENT ONLY: Regularly (self-defined) participation in psychotherapy or a formal cancer support group
- PATIENT ONLY: Cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Online Dyadic Mind-Body Intervention for Glioma Patients and Their Partners
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine the feasibility of the couple-based mind-body (CBMB) program in patients with high grade glioma (HGG) and their partners.
II. Establish the initial efficacy of the CBMB program in patients and their partners regarding spiritual (primary), psychological and physical quality of life (QOL) (secondary) outcomes relative to a waitlist control (WLC) group.
EXPLORATORY OBJECTIVES:
- Explore potential mediation (i.e., mindfulness, compassion, holding back, and intimacy) and moderation (e.g., baseline medical, demographic and psychosocial factors) effects of the intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (CBMB PROGRAM): 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 (WAITLIST CONTROL): Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.
After completion of study, patients are followed up at 3 months.
- Conditions
- Glioblastoma, Low Grade Glioma, Malignant Glioma, Metastatic Malignant Neoplasm in the Brain, Partner, WHO Grade III Glioma
- Being tested
- Mind-Body Intervention Procedure, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Glioblastoma, Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Intervention ProcedureProcedure or surgery
Also called Mind-Body Interventions, Mind-Body Medicine
Undergo CBMB program
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (CBMB program) | Experimental | 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. Receives: Procedure: Mind-Body Intervention Procedure; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group II (waitlist control) | Active comparator | Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual
Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.
Measured: Up to 6 weeks
Feasibility of CBMB program as determined by attrition
Trial considered feasible if 80% of enrolled couples complete T1 and T2 assessments. Will calculate rates, frequencies, and 90% CIs, as applicable.
Measured: Up to 6 weeks
Feasibility of CBMB program as determined by adherence
Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable.
Measured: Up to 6 weeks
Feasibility of CBMB program as determined by acceptability
Trial considered feasible if > 75% of patients in the CBMB group rate the intervention as acceptable. Will calculate rates, frequencies, and 90% CIs, as applicable.
Measured: Up to 6 weeks
CBMB program efficacy
Will calculate effect sizes for pairwise between-group comparisons of intervention outcomes at T2. Will test for between-group differences in the change of scores between T1 and T2 using analysis of variance.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start6 Aug 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathrin Milbury, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244995
- Sponsor's protocol ID
- 2017-0290
- Other IDs
- NCI-2018-01099, 2017-0290
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2017
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Dyadic Mind-Body Intervention for Glioma Patients and Their Partners
- ClinicalTrials.gov ID
- NCT03244995
- Acronym / sponsor ID
- 2017-0290
- Conditions
- Glioblastoma, Low Grade Glioma, Malignant Glioma, Metastatic Malignant Neoplasm in the Brain, Partner, WHO Grade III Glioma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Aug 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Examine the feasibility of the couple-based mind-body (CBMB) program in patients with high grade glioma (HGG) and their partners.
II. Establish the initial efficacy of the CBMB program in patients and their partners regarding spiritual (primary), psychological and physical quality of life (QOL) (secondary) outcomes relative to a waitlist control (WLC) group.
EXPLORATORY OBJECTIVES:
- Explore potential mediation (i.e., mindfulness, compassion, holding back, and intimacy) and moderation (e.g., baseline medical, demographic and psychosocial factors) effects of the intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (CBMB PROGRAM): 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 (WAITLIST CONTROL): Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.
After completion of study, patients are followed up at 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (CBMB program) | Experimental | Procedure: Mind-Body Intervention Procedure, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (waitlist control) | Active comparator | Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PATIENT ONLY: 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
- PATIENT ONLY: Patients must be within 1 month of initiating or having undergone any type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy)
- PATIENT ONLY: Karnofsky performance status (KPS) of 80 or above
- PATIENT ONLY: Having a spouse/romantic partner (including same-sex) and who is willing to participate
- PATIENT \& PARTNER: Able to read and speak English
Key exclusion criteria (2 listed)
- PATIENT ONLY: Regularly (self-defined) participation in psychotherapy or a formal cancer support group
- PATIENT ONLY: Cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-Body Intervention ProcedureAlso: Mind-Body Interventions, Mind-Body MedicineUndergo CBMB program | Procedure or surgery | Group I (CBMB program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (CBMB program), Group II (waitlist control) |
| Questionnaire AdministrationAncillary studies | Other | Group I (CBMB program), Group II (waitlist control) |
Primary outcome
Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual
Time frame: Up to 6 weeks
Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.
Feasibility of CBMB program as determined by attrition
Time frame: Up to 6 weeks
Trial considered feasible if 80% of enrolled couples complete T1 and T2 assessments. Will calculate rates, frequencies, and 90% CIs, as applicable.
Feasibility of CBMB program as determined by adherence
Time frame: Up to 6 weeks
Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable.
Feasibility of CBMB program as determined by acceptability
Time frame: Up to 6 weeks
Trial considered feasible if > 75% of patients in the CBMB group rate the intervention as acceptable. Will calculate rates, frequencies, and 90% CIs, as applicable.
CBMB program efficacy
Time frame: Up to 6 weeks
Will calculate effect sizes for pairwise between-group comparisons of intervention outcomes at T2. Will test for between-group differences in the change of scores between T1 and T2 using analysis of variance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathrin Milbury principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Intervention Procedure, Quality-of-Life Assessment and Questionnaire Administration in people with Glioblastoma and Low Grade Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual (time frame: Up to 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.