Mind-Body Intervention in Glioma Couples (NCT03244995) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mind-Body Intervention in Glioma Couples
United States74 participantsStarted 2017-08-06
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual
Timeframe: Up to 6 weeks
2
Feasibility of CBMB program as determined by attrition
Timeframe: Up to 6 weeks
3
Feasibility of CBMB program as determined by adherence
Timeframe: Up to 6 weeks
4
Feasibility of CBMB program as determined by acceptability