An interventional study of yoga therapy and questionnaire administration in Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma and Adult Anaplastic Meningioma, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-03.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
This clinical trial studies yoga therapy in treating patients with malignant brain tumors. Yoga therapy may improve the quality of life of patients with brain tumors
PRIMARY OBJECTIVES:
I. To estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors.
SECONDARY OBJECTIVES:
I. To obtain estimates of the variability of self-reported fatigue, distress (i.e., depression, anxiety), sleep disturbance, cognitive function, and health-related quality of life from baseline to the end of the intervention at 6 (post-onsite intervention) and 12 weeks (post-full intervention).
II. To obtain preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function.
III. To standardize the cancer-specific yoga protocol for use with brain tumor patients.
OUTLINE:
Patients participate in yoga classes comprising postures, deep relaxation, breathing practices, and meditation twice weekly for 75 minutes during weeks 1-6. Patients then practice yoga at home twice weekly for 45 minutes during weeks 7-12.
After completion of study treatment, patients are followed up periodically for 4-5 months.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's enrollment of 9 is below the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Compared within Glioblastoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Astrocytoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed protocol specific Are diagnosed with a Malignant Brain Tumor (Grades II-IV) Able to start the on-site yoga intervention within 1 week of first radiation treatment Are physically able to attend the intervention classes ( [ECOG] performance status rating 0-2) Able to understand written and spoken English Have no medical reported by the attending physician
Exclusion Criteria:
Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit participants who are not already regularly practicing yoga; given that the benefits of yoga are likely more immediate than long-term, however, we will enroll participants who have previously had a yoga practice
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients participate in yoga classes comprising postures, deep relaxation, breathing practices, and meditation twice weekly for 75 minutes during weeks 1-6. Patients then practice yoga at home twice weekly for 45 minutes during weeks 7-12.
Procedure: yoga therapy · Other: questionnaire administration · Procedure: quality-of-life assessment
Participates in yoga classes and yoga at home
Also known as: yoga
Ancillary studies
Ancillary studies
Also known as: quality of life assessment
Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors
Track barriers to recruitment. Participation rate calculated as proportion of eligible patients who agree to participate. Study retention estimated as proportion of participating patients who complete questionnaires at Week 6. Further retention data obtained by tracking # of dropouts, when dropout occurs, \& reasons for dropout. Intervention adherence estimated as mean % of yoga classes attended. Summary statistics for patient characteristics, participation rates, adherence \& retention. 95% confidence intervals calculated for each feasibility measure.
Time frame: Up to 12 weeks
Self-reported fatigue
Time frame: Up to 12 weeks
Depressive symptoms
Time frame: Up to 12 weeks
Distress
Time frame: Up to 12 weeks
Health-related quality of life
Time frame: Up to 12 weeks
Preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function
Time frame: Up to 12 weeks
Standardize the cancer-specific yoga protocol for use with brain tumor patients
Time frame: At the end of therapy
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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