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

12 oktober 2021 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

53

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rotterdam Symptom Checklist
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Hicran Bektas, PhD, RN, Akdeniz University
  • Hoofdonderzoeker: Hasan S Coskun, Medical Dr, Akdeniz University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2014

Primaire voltooiing (Werkelijk)

1 mei 2015

Studie voltooiing (Werkelijk)

1 februari 2016

Studieregistratiedata

Eerst ingediend

29 september 2021

Eerst ingediend dat voldeed aan de QC-criteria

12 oktober 2021

Eerst geplaatst (Werkelijk)

13 oktober 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 oktober 2021

Laatste update ingediend die voldeed aan QC-criteria

12 oktober 2021

Laatst geverifieerd

1 oktober 2021

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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