What this study is
This trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their caregivers. A customized neuro-imaging referenced symptom video that describes symptoms and side effects specific to the patients' tumor may result in an early and sustained reduction in anxiety and distress during and after radiation treatment, thereby improving quality of life.
What's being tested
- Educational Intervention
Intervention · OTHER
Receive standard of care verbal and written education materials
- Questionnaire Administration
Intervention · OTHER
Ancillary studies
- Survey Administration
Intervention · OTHER
Complete optional survey
- Video
Intervention · OTHER
Watch NIRS video
Study details
- Official title
- Novel Intervention to Reduce Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors With a Customized Neuro-Imaging Referenced Symptom Video
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Glioblastoma · WHO Grade II Glioma · WHO Grade III Glioma
- Enrolling
- 117 people
- Starts
- 2019-06-05
- Est. completion
- 2027-02-02
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- PATIENT ELIGIBILITY CRITERIA: Adult patients with newly diagnosed glioma (World Health Organization [WHO] grade 2-4) who are planned for a 6-week course of radiotherapy after surgery
- PATIENT ELIGIBILITY CRITERIA: Able to complete questionnaires in English
- PATIENT ELIGIBILITY CRITERIA: Has a post-operative diagnostic magnetic resonance imaging (MRI) of the brain with and without contrast acquired within 4 weeks of the start of radiotherapy
- CAREGIVER ELIGIBILITY CRITERIA: Adult caregiver (>= 18 years) who is accompanying an eligible patient consented to the study
- CAREGIVER ELIGIBILITY CRITERIA: The patient who the caregiver is accompanying is consented for participation on the study
- CAREGIVER ELIGIBILITY CRITERIA: Able and willing to complete questionnaires in English
You can't join if
- PATIENT ELIGIBILITY CRITERIA: Significant cognitive or psychiatric symptoms that prevent the ability to complete the questionnaires as determined by the assessing staff in the pre-intervention evaluation
- PATIENT ELIGIBILITY CRITERIA: Poor performance status (Karnofsky performance status [KPS] < 60) that prevent the ability to complete the questionnaires
- CAREGIVER ELIGIBILITY CRITERIA: Significant cognitive or psychiatric symptoms that prevent the ability to complete the questionnaires as determined by the assessing staff in the pre-intervention evaluation
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openM D Anderson Cancer Center
Houston, Texas, United States
- Caroline Chung · Contact713-563-2300
- Caroline Chung · Principal investigator
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2018-0097
Principal investigator
Caroline Chung
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.