Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05076916 |
Other study ID # |
2520 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 2014 |
Est. completion date |
February 2016 |
Study information
Verified date |
October 2021 |
Source |
Akdeniz University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.