Feasibility and safety of delivering telerehabilitation early and concurrently with radiation therapy for individuals with primary brain tumours Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 years of age of older 2. Planned to undergo an initial course of radiation for a diagnosis of intracranial glioma (any grade) 3. Recent brain surgery (within 12 weeks) 4. Eastern Cooperative Oncology Group (ECOG) performance status greater than (>) 1 at time of enrollment 5. Have a caregiver, friend, or family member available to provide physical support during the initial assessment session and Active Rehab sessions 6. Eligible to be prescribed Brain HQ and home exercises 7. Have an email address, or caregiver, friend or family member has an email address 8. Have cognitive-communicative ability to participate as per clinical judgement 9. Able to provide informed consent, or if not, have a legal decision maker 10. Access to a space with necessary therapy requirements (e.g. must have sturdy chair with armrests; if the room is carpeted, must be low-pile) 11. Able to understand English to the point that they are able to follow instructions and express levels of exertion, pain, distress, etc, as determined by the study team
Exclusion criteria
Exclusion criteria: 1. Undergoing a repeat course of in-field irradiation for a recurrent brain tumour 2. Spinal glioma 3. Currently receiving inpatient or outpatient rehabilitation 4. Living in long-term care 5. Severe vision or hearing loss impacting ability to participate actively in rehabilitation 6. Planned surgery that would preclude or affect participation in the protocol 7. Contraindications to radiation therapy (e.g. pregnancy, or trying to conceive)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of participants who complete the intervention measured using study data from enrollment to the end of the intervention (outpatient telerehabilitation) at 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment of participants, measured by the percentage of eligible patients who consent to the trial at the point of initial recruitment contact. 2. Telerehab session attendance (Active Rehab group), measured by percentage of telerehabilitation sessions attended, from enrollment to the end of treatment at week 8. 3. BrainHQ/exercise program usage (Usual Care group), measured by percentage of participants engaging with BrainHQ and/or exercise programs, from enrollment to the end of treatment at week 8. 4. Retention – time needed for data collection, measured by minutes required to complete questionnaires and physical/cognitive assessments, from enrollment to the end of treatment at week 8 and at week 26. 5. Participant experience, measured by semi-structured qualitative interviews exploring perceptions of the telerehabilitation intervention, at week 26. 6. Percentage and type of adverse events (AE) among participants who experienced an AE, measured by distribution and relatedness of event types, from enrollment to the end of treatment at week 8. 7. Change from baseline in the Fatigue Severity Scale, measured by 9-item scale scores ranging from 1 to 7, at 0, 4, 8, 12, and 26 weeks. 8. Overall survival, measured by time from intervention start until death from any cause, at 4, 8, 12, and 26 weeks. 9. Progression-free survival, measured by time from treatment start until disease progression or death, at 4, 8, 12, and 26 weeks. 10. Change from baseline in the EuroQol-5 Dimension 5 Level (EQ-5D-5L), measured by self-report scores across five domains, at 0, 4, 8, 12, and 26 weeks. 11. Change from baseline in the Perceived Medical Condition Self-Management Scale, measured by 8-item self-efficacy scores ranging from 8 to 40, at 0, 4, 8, 12, and 26 weeks. 12. Change from baseline in the Berg Balance Scale, measured by 14-item scores ranging from 0 to 56, at 0, 4, 8, 12, and 26 weeks. 13. Change from baseline in the Timed Up and Go, measured by time in seconds to | — |
Countries
Canada
Contacts
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