The Effects of a Media Diversion on Quality of Life in Patients Receiving Chemotherapy for Recurrent Gynecologic Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Patient-reported mood using the Positive and Negative Affect Scale-Expanded Form (PANAS-X) instrument
研究概览
简要总结
This randomized clinical trial studies media diversion in improving quality of life in patients with recurrent gynecologic cancers receiving chemotherapy. Media diversion may improve mood and quality of life in patients having cancer treatment.
详细描述
PRIMARY OBJECTIVES:
I. To analyze the impact of a media-based intervention on patient mood during the receipt of chemotherapy for recurrent gynecologic cancers.
OUTLINE: are randomized to 1 of 2 arms.
ARM I: Participants are provided headphones and a tablet and choose among a selection of humorous movies. Upon the third course of chemotherapy, participants are provided a selection of non-humorous movies.
ARM II: Participants are provided headphones and a tablet and choose among a selection of non-humorous movies. Upon the third course of chemotherapy, participants are provided a selection of humorous movies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects with pathologically-proven gynecologic malignancies
- •Subjects who have previously completed primary treatment for a gynecologic malignancy
- •Patients receiving chemotherapy for a recurrent gynecologic cancer at the University of Wisconsin-Madison Carbone Cancer Center (UWCCC)
- •Patients must be English speaking
- •Patients must have the ability to use audio media and read and understand written English
排除标准
- •Patients unable to use audio or video media due to auditory or ocular dysfunction
- •Patients unable to read written English
- •Patients who are prisoners or incarcerated
研究组 & 干预措施
Arm I (humorous followed by non-humorous movies)
Participants are provided headphones and a tablet and choose among a selection of humorous movies. Upon the third course of chemotherapy, participants are provided a selection of non-humorous movies.
干预措施: mind-body intervention procedure (Procedure)
Arm I (humorous followed by non-humorous movies)
Participants are provided headphones and a tablet and choose among a selection of humorous movies. Upon the third course of chemotherapy, participants are provided a selection of non-humorous movies.
干预措施: survey administration (Other)
Arm I (humorous followed by non-humorous movies)
Participants are provided headphones and a tablet and choose among a selection of humorous movies. Upon the third course of chemotherapy, participants are provided a selection of non-humorous movies.
干预措施: quality-of-life assessment (Procedure)
Arm II (non-humorous followed by humorous movies)
Participants are provided headphones and a tablet and choose among a selection of non-humorous movies. Upon the third course of chemotherapy, participants are provided a selection of humorous movies.
干预措施: mind-body intervention procedure (Procedure)
Arm II (non-humorous followed by humorous movies)
Participants are provided headphones and a tablet and choose among a selection of non-humorous movies. Upon the third course of chemotherapy, participants are provided a selection of humorous movies.
干预措施: survey administration (Other)
Arm II (non-humorous followed by humorous movies)
Participants are provided headphones and a tablet and choose among a selection of non-humorous movies. Upon the third course of chemotherapy, participants are provided a selection of humorous movies.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Patient-reported mood using the Positive and Negative Affect Scale-Expanded Form (PANAS-X) instrument
时间窗: Up to day 1 of course 3 of chemotherapy
Summarized in terms of means, standard deviations and ranges, stratified by group and assessment time point. Absolute and percentage changes from baseline within each group will be calculated and reported in terms of means and the corresponding 95% confidence intervals. Changes from baseline will be evaluated using a paired t-test. A Grizzle model for a 2 X 2 cross-over design will be used to compare changes in PANAS-X positive and negative affect scores between groups.
次要结局
- Ease of use (EoS) score(Up to day 1 of course 3 of chemotherapy)
- Humor Styles Questionnaire (HSQ) total score(Up to day 1 of course 3 of chemotherapy)
- Quality of materials (QOM) score(Up to day 1 of course 3 of chemotherapy)
- Brief Fatigue Inventory (BFI) total score(Up to day 1 of course 3 of chemotherapy)