Media Diversion in Improving Quality of Life in Patients With Recurrent Gynecologic Cancers Receiving Chemotherapy
2019年11月14日 更新者：University of Wisconsin, Madison
The Effects of a Media Diversion on Quality of Life in Patients Receiving Chemotherapy for Recurrent Gynecologic Cancers
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
67
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Wisconsin
-
Madison、Wisconsin、美国、53792
- University of Wisconsin Hospital and Clinics
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
辅助研究
其他名称：
辅助研究
Participate in media diversion with humorous and non-humorous movies
其他名称：
|
|
实验性的：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.
|
辅助研究
其他名称：
辅助研究
Participate in media diversion with humorous and non-humorous movies
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-reported mood using the Positive and Negative Affect Scale-Expanded Form (PANAS-X) instrument
大体时间：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.
|
Up to day 1 of course 3 of chemotherapy
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Humor Styles Questionnaire (HSQ) total score
大体时间：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 HSQ total scores between groups.
|
Up to day 1 of course 3 of chemotherapy
|
|
Brief Fatigue Inventory (BFI) total score
大体时间：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 BFI total scores between groups.
|
Up to day 1 of course 3 of chemotherapy
|
|
Ease of use (EoS) score
大体时间：Up to day 1 of course 3 of chemotherapy
|
Assessed with a Likert scale at the completion of the subject's participation to understand how the intervention may be improved should results of this study favor implementation into standard clinical procedure for future patients.
Summarized in terms of medians and ranges, stratified by group and assessment time point.
Changes from baseline within each group will be evaluated using a nonparametric Wilcoxon Signed Rank test
|
Up to day 1 of course 3 of chemotherapy
|
|
Quality of materials (QOM) score
大体时间：Up to day 1 of course 3 of chemotherapy
|
Assessed with a Likert scale at the completion of the subject's participation to understand how the intervention may be improved should results of this study favor implementation into standard clinical procedure for future patients.
Summarized in terms of medians and ranges, stratified by group and assessment time point.
Changes from baseline within each group will be evaluated using a nonparametric Wilcoxon Signed Rank test
|
Up to day 1 of course 3 of chemotherapy
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Stephen Rose、University of Wisconsin, Madison
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年2月12日
初级完成 (实际的)
2016年5月24日
研究完成 (实际的)
2017年2月8日
研究注册日期
首次提交
2013年7月12日
首先提交符合 QC 标准的
2013年7月12日
首次发布 (估计)
2013年7月17日
研究记录更新
最后更新发布 (实际的)
2019年11月19日
上次提交的符合 QC 标准的更新
2019年11月14日
最后验证
2017年3月1日
更多信息
与本研究相关的术语
其他研究编号
- UW13037
- P30CA014520 (美国 NIH 拨款/合同)
- A532820 (其他标识符：UW Madison)
- NCI-2013-01284 (注册表标识符：NCI Trial ID)
- 2013-0618 (其他标识符：Institutional Review Board)
- SMPH/OBSTET & GYNECOL/ (其他标识符：UW Madison)
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