Novel Intervention to Reduce Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors With a Customized Neuro-Imaging Referenced Symptom Video
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Changes in patient S-Anxiety subscale score of the State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVE:
I. To determine if provision of a neuro-imaging referenced symptom (NIRS) video intervention for patients starting radiotherapy for newly diagnosed primary brain tumors reduces patient anxiety during radiation compared to standard of care information.
SECONDARY OBJECTIVES:
I. To determine if provision of a NIRS video intervention for patients starting radiotherapy for newly diagnosed primary brain tumors reduces caregiver anxiety during radiation compared to standard of care information.
II. To determine if any changes in patient or caregiver anxiety early during radiation are sustained after the completion of radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (NIRS)
Patients receive standard of care verbal and written education materials. Patients also receive a customized video which includes a description of each of their tumor, functional areas of the brain affected, and possible symptoms from the tumor and radiation treatment based on the neuro-imaging features. Patients and their caregivers watch the video together or separately over 1.5-3 minutes before the end of the first week of radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an optional survey over 5-10 minutes.
干预措施: Video (Other)
Arm I (NIRS)
Patients receive standard of care verbal and written education materials. Patients also receive a customized video which includes a description of each of their tumor, functional areas of the brain affected, and possible symptoms from the tumor and radiation treatment based on the neuro-imaging features. Patients and their caregivers watch the video together or separately over 1.5-3 minutes before the end of the first week of radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an optional survey over 5-10 minutes.
干预措施: Educational Intervention (Other)
Arm I (NIRS)
Patients receive standard of care verbal and written education materials. Patients also receive a customized video which includes a description of each of their tumor, functional areas of the brain affected, and possible symptoms from the tumor and radiation treatment based on the neuro-imaging features. Patients and their caregivers watch the video together or separately over 1.5-3 minutes before the end of the first week of radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an optional survey over 5-10 minutes.
干预措施: Questionnaire Administration (Other)
Arm I (NIRS)
Patients receive standard of care verbal and written education materials. Patients also receive a customized video which includes a description of each of their tumor, functional areas of the brain affected, and possible symptoms from the tumor and radiation treatment based on the neuro-imaging features. Patients and their caregivers watch the video together or separately over 1.5-3 minutes before the end of the first week of radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an optional survey over 5-10 minutes.
干预措施: Survey Administration (Other)
Arm II (standard of care)
Patients receive standard of care verbal and written education materials.
干预措施: Educational Intervention (Other)
Arm II (standard of care)
Patients receive standard of care verbal and written education materials.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Changes in patient S-Anxiety subscale score of the State-Trait Anxiety Inventory (STAI)
时间窗: From baseline to 2 weeks, 6 weeks and 1 month post-radiation therapy (RT)
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.
次要结局
- Changes in caregiver S-Anxiety subscale score of the STAI and Distress Thermometer score(From baseline to 2 and 6 weeks)
- Change in patient and caregiver S-Anxiety subscale score of the STAI and Distress Thermometer scores(From baseline to 1 month post-RT)
- Changes in patient Distress Thermometer score and FACT-Br score(From baseline to 2 weeks, 6 weeks, and 1 month post-RT)
- Patient survey(Up to 1 month post-RT)