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Web-based InterventionNCT05076916

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

A study testing The effectiveness of the web-based education programme among cancer patients in people with Web-based Intervention and Cancer, run by Akdeniz University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Web-based Intervention, Cancer
What is being tested?
The effectiveness of the web-based education programme among cancer patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
No sites listed yet
Study dates
May 2014to Feb 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Having diagnosed with psychiatric disease

About this study

Official title: 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.

Read the detailed 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.

Being tested
The effectiveness of the web-based education programme among cancer patients
Keywords
Cancer, Nursing, Self Efficacy, Symptom Management, Quality of Life, Web-Based Education
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The effectiveness of the web-based education programme among cancer patientsBehavioural

    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.

Study groups in NCT05076916
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Behavioral: The effectiveness of the web-based education programme among cancer patients
Control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rotterdam Symptom Checklist

    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.

    Measured: 12 week

  2. EORTC-QLQ-C30 Quality of Life Scale

    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.

    Measured: 12 week

  3. Strategies Used by Patients to Promote Health

    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.

    Measured: 12 week

  4. Beck Depression Scale

    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.

    Measured: 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study startMay 2014
  3. Primary completionMay 2015
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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 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. The control group received routine patient education and routine hospital follow-ups given by Oncology Education Nurses during the three-month follow-up period.
Masking
Single blind
Who is masked
Participant
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05076916
Sponsor's protocol ID
2520
Status last verified
Oct 2021
First submitted
29 Sep 2021
Last updated
13 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bektas H, Coskun HS, Arikan F, Ozcan K, Tekeli A, Kondak Y, Sezgin MG, Yangec E, Kalav S. Development and evaluation of the efficacy of a web-based education program among cancer patients undergoing treatment with systemic chemotherapy: a randomized controlled trial. Support Care Cancer. 2022 Jul;30(7):6021-6033. doi: 10.1007/s00520-022-07039-w. Epub 2022 Apr 12.

    PubMed 35412076

Questions about this trial

What is this clinical trial studying?

A study testing The effectiveness of the web-based education programme among cancer patients in people with Web-based Intervention and Cancer, run by Akdeniz University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rotterdam Symptom Checklist (time frame: 12 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05076916, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.

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