此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

The Effectiveness of the Web-based Education Programme Among Cancer Patients

2021年10月12日 更新者:Hicran Bektas、Akdeniz University

Development and Evaluation of the Effectiveness of the Web-based Education Programme Among Cancer Patients Undergoing Treatment of Systemic Chemotherapy: A Randomised Controlled Trial

This study aims to develop a web-based education program among cancer patients undergoing treatment of systemic chemotherapy and to evaluate the effect of the program on symptom control, quality of life, self-efficacy, and depression. Evaluating the effect of the web-based education programme among cancer patients will be useful in planning appropriate remote nursing interventions to increase the symptom control and quality of life of patients.

A web-based education program was prepared in line with patient needs, evidence-based guidelines, and expert opinions and tested with 10 cancer patients. A single-blind, randomised controlled study design was applied. Pre-tests were applied to 60 cancer patients undergoing systemic chemotherapy, and the patients (intervention:30, control: 30) were randomized. The intervention group used the web-based education program for three months, and they were allowed to communicate with the researchers 24/7 via the website. The effectiveness of the web-based education program at baseline and after 12 weeks evaluated.

研究概览

详细说明

Cancer is a life-threatening disease with negative physical, psychological, and socioeconomic effects. Patients with cancer receive outpatient chemotherapy and must manage the most important symptoms of chemotherapy at home without the support of a healthcare professional. Patients with cancer and their families need to be supported not only in the hospital but also in the home environment. Patients want to receive information about strategies for coping with symptoms or problems that they encounter frequently after treatment. It has been reported that the rate of use and effectiveness of web-based programs planned by determining the needs of patients with cancer will be higher. Although experimental studies examining the effect of health education and counseling conducted on the web are limited, no web-based education program created by evaluating the needs of patients with cancer has been found. Our study was conducted to determine the needs of patients with cancer for a web-based education program and to design a program to meet the needs.

The primary aim of the study is to develop a web-based education program for patients with cancer receiving systemic treatment and to test the validity of this program. The secondary aim is to evaluate the effect of this web-based education program on symptom control, quality of life, self-efficacy, and depression in patients with cancer undergoing systemic chemotherapy.

In the first stage of the study, the needs of patients for web-based education were determined using a descriptive design, and in the second stage, the effectiveness of the web-based education program was evaluated using a randomized controlled trial design, with the participants being single-blinded. A randomized controlled trial based on the Consolidated Standard of Reporting Trials - CONSORT 2010 - guidelines was performed.

In the first stage of the study, 30 patients with cancer were interviewed to determine their expectations regarding their needs for web-based education. In the second stage of the study, the sample size was calculated on the G*POWER software package based on an 85% power and a 5% confidence interval. The study was conducted with patients with cancer (n=60), including 30 in the intervention and 30 in the control groups. The study consisted of patients who were over the age of 18, received at least two cycles of systemic chemotherapy, had no verbal communication disorder, were literate, had Internet access and use the Internet. Data of both stages of the study were collected between May 7, 2014, and February 17, 2016.

The effect of the web-based education program on patient outcomes was analyzed by dividing the participants into groups through randomization. All patients with cancer who met the sampling criteria were assigned to the intervention and control groups through block randomization (1:1). The researchers used a randomization list created on a computer application (https://www.randomizer.org/). Pretest data of the study were collected from patients who consented to participate in the study by two independent researchers who were not involved in the implementation of the study. For assigning each patient to a group, the other team members were called by the same independent researcher, and the subjects were assigned to the groups according to the randomization list created. Two independent researchers conducted the assignment of the participants on the intervention and control groups and the evaluation of the outcome measurement data. Since the researchers conducted the interventions, they were not be blinded. However, the participants were blinded because they did not know the hypotheses of the study and which group they were in.

In the first phase of the study, a web-based education program was developed. For this purpose, the researchers developed a "Web-Based Education Needs Assessment Form for Patients with Cancer" based on a review of the literature. In line with the needs analysis and literature, the research team created a web-based education program. A group of 10 experts evaluated the content of the program, including three oncology physicians, four nursing faculty members, and three nurses.

After obtaining expert opinions, a pilot study was conducted with 10 different patients with cancer who met the sampling criteria. The intelligibility and usability of the program were tested in the pilot study. Patients with cancer included in the first stage of the study were not included in the second stage.

In the second phase of the study, the web-based education program was introduced to the patients with cancer in the intervention group during face-to-face interviews. They were asked to examine the program for at least two hours a week for three months. During the follow-up period, the patients in the intervention group were called twice a week and reminded to use the education program. The researchers get in contact with the patients online via the website. During the follow-up period, the patients contact the research team by calling or writing messages via the website 24/7. An e-mail account was created by the research team using the email system of the university, and it was shared with the patients. The clinical researchers of the team answered the patients' questions via this e-mail account. Within the scope of the study, a new cell phone number was purchased, and the researchers used on a rotating basis to answer patients' questions as a phone response system. During the follow-up, patients' questions were answered on the phone. The control group received routine patient education and routine hospital follow-ups given by Oncology Education Nurses during the three-month follow-up period. In the third month, after the follow-up stage of the study was completed, the post-tests were administered to the patients in the intervention and control groups who came to the hospital for follow-up or treatment. The outcome measures of the study were determined as the symptoms experienced by patients with cancer, quality of life, self-efficacy, and depression levels.

研究类型

介入性

注册 (实际的)

53

阶段

  • 不适用

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 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Between 18-70 years
  • Received at least two cycles of systemic chemotherapy
  • Had no verbal communication disorder
  • Literate
  • Had Internet access
  • Use the Internet

Exclusion Criteria:

  • Having diagnosed with psychiatric disease

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:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention group
The web-based education program was introduced to the patients with cancer in the intervention group during face-to-face interviews. They were asked to examine the program for at least two hours a week for three months. During the follow-up period, the patients in the intervention group were called twice a week and reminded to use the education program. The researchers get in contact with the patients online via the website. During the follow-up period, the patients contact the research team by calling or writing messages via the website 24/7. An e-mail account was created by the research team using the email system of the university, and it was shared with the patients. The clinical researchers of the team answered the patients' questions via this e-mail account. In the third month, after the follow-up stage of the study was completed, the post-tests were administered to the patients in the intervention group who came to the hospital for follow-up or treatment.
The web-based education program was introduced to the patients with cancer in the intervention group during face-to-face interviews. They were asked to examine the program for at least two hours a week for three months. During the follow-up period, the patients in the intervention group were called twice a week and reminded to use the education program. The researchers get in contact with the patients online via the website. The patients contact the research team by calling or writing messages via the website 24/7. An e-mail account was created by the research team using the email system of the university, and it was shared with the patients. The clinical researchers of the team answered the patients' questions via this e-mail account.
无干预:Control group
The control group received routine patient education and routine hospital follow-ups given by Oncology Education Nurses during the three-month follow-up period. In the third month, after the follow-up stage of the study was completed, the post-tests were administered to the patients in the control group who came to the hospital for follow-up or treatment.

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
Rotterdam Symptom Checklist
大体时间:12 week
The Rotterdam Symptom Checklist is used to evaluate the problems of patients with cancer developing due to the symptoms they experience. The items on the scale are scored between 1 and 4 by using a Likert-type scoring system. The scale consists of 39 items and has 4 sub-dimensions: Physical Symptom Discomfort, Psychological Discomfort, Activity Level, and Quality of Life. The higher the scores obtained from the scale, the greater the distress. Cronbach's alpha value of the scale was determined as 0.88.
12 week
EORTC-QLQ-C30 Quality of Life Scale
大体时间:12 week
The EORTC-QLQ-C30 Quality of Life Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.
12 week
Strategies Used by Patients to Promote Health
大体时间:12 week
This scale is used to assess the self-confidence of individuals in fulfilling the strategies they use to improve health. It consists of 29 items under 3 sub-dimensions, namely, coping with stress, decision making, and positive behavior development. The scores that can be obtained from the scale range from 29 to 145, and increased scores indicate an increased level of self-efficacy. Cronbach's alpha value of the scale was found as 0.92.
12 week
Beck Depression Scale
大体时间:12 week
Beck Depression Scale is a self-assessment scale that measures the symptoms of depression observed in physical, emotional, cognitive, and motivational areas. The purpose of the scale is not to diagnose of depression, but to objectively measure the severity of depressive symptoms. Each of the 21 items on the scale includes four statements numbered 0, 1, 2, and 3. Two of the items on the scale are reserved for emotions, eleven items for cognitions, two items for behavior, five items for somatic symptoms, and one item for interpersonal symptoms. The total score that can be obtained from the scale varies between 0 and 63, and the scores are interpreted as follows: 0-9, no depression; 10-15, mild depression, 16-23 moderate depression, and 24-63 severe depression.
12 week

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

  • 研究主任:Hicran Bektas, PhD, RN、Akdeniz University
  • 首席研究员:Hasan S Coskun, Medical Dr、Akdeniz University

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 (实际的)

2014年5月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2016年2月1日

研究注册日期

首次提交

2021年9月29日

首先提交符合 QC 标准的

2021年10月12日

首次发布 (实际的)

2021年10月13日

研究记录更新

最后更新发布 (实际的)

2021年10月13日

上次提交的符合 QC 标准的更新

2021年10月12日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅