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.
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
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
Parallel
Educational Intervention
Other interventionReceive standard of care verbal and written education materials
Questionnaire Administration
Other interventionAncillary studies
Survey Administration
Other interventionComplete optional survey
Video
Other interventionWatch NIRS video
Changes in patient S-Anxiety subscale score of the State-Trait Anxiety Inventory (STAI)
Using linear mixed models (LMMs) to evaluate the change in STAI between and within groups. The correlation structure over time will be selected using the Bayesian information criterion. Will calculate correlations between reduction in anxiety and improvement in quality of life (Functional Assessment of Cancer Therapy Scale-Brain \[FACT- Br\]) and distress (Distress Thermometer). Analysis will focus on the between-group comparison of the changes of the patient S-Anxiety subscale score of the STAI from baseline to 2 weeks and from baseline to 6 weeks in to RT. All tests conducted will use a two-sided 0.05 significance level, without adjusting for multiple testing.
Changes in caregiver S-Anxiety subscale score of the STAI and Distress Thermometer score
Analysis will focus on the between-group comparison of the changes of the caregiver S-Anxiety subscale score of the STAI from baseline to 2 weeks and from baseline to 6 weeks in to RT. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.
Change in patient and caregiver S-Anxiety subscale score of the STAI and Distress Thermometer scores
Analysis will be performed by testing for the effects of time, in particular, differences between the average of weeks 2 and 6 during RT and 1 month after RT. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.
Changes in patient Distress Thermometer score and FACT-Br score
Evaluates the impact between distress and overall quality of life in patients. LMMs will be used to assess the correlations between change in anxiety and change in quality of life, etc., without including time as an independent variable, yet with within-subject correlations still accounted for. For each fixed time point, simple correlations will also be calculated. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.
Patient survey
Evaluates whether neuro-imaging referenced symptom intervention was subjectively helpful in understanding their tumor and treatment symptoms and alleviating their anxiety. Relevant summary statistics will be computed. All tests conducted will use a two-sided .05 significance level, without adjusting for multiple testing.
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
