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Decision Support SystemLympSCareNCT05443165

The Effect of Decision Support System on Symptom Self-Management in Non-Hodgkin Lymphoma Patients

A study testing The effectiveness of the online decision support system developed for symptom self-management and Symptom self-management with an education booklet in people with Decision Support System and Non-Hodgkin Lymphoma, run by Akdeniz University at 1 site in Turkey (Türkiye).

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 evaluate the effect of the decision support system developed for symptom self-management on symptom management, quality of life, and unplanned hospital admissions in Non-Hodgkin lymphoma (NHL) patients. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Decision Support System, Non-Hodgkin Lymphoma
What is being tested?
The effectiveness of the online decision support system developed for symptom self-management and Symptom self-management with an education booklet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteTurkey (Türkiye)
Study dates
31 Jan 2024to 30 Jun 2024
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years and older
  • Diagnosed with NHL (Diffuse Large B Cell Lymphoma and Follicular Lymphoma)
  • Chemotherapy for the first time due to the diagnosis of NHL
  • Have received at least two cycles of chemotherapy
  • ECOG performance score of 0-1-2
  • Had no verbal communication disorder
  • Literate
  • Having internet access at home, having a device such as a tablet, computer, or phone, and being able to use these tools

Who cannot join

  • Having metastases
  • Undergoing major surgery
  • With terminal disease
  • ECOG performance score of 3 and above

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Akdeniz Üniversitesi

    Antalya, 07058

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of the Decision Support System Developed for Symptom Self-Management in Non-Hodgkin Lymphoma Patients on Symptom Management, Quality of Life, and Unplanned Hospital Admissions

This study aims to evaluate the effect of the decision support system developed for symptom self-management on symptom management, quality of life, and unplanned hospital admissions in Non-Hodgkin lymphoma (NHL) patients. Since NHL patients often experience disease and treatment-related side effects after discharge from the hospital, it would be beneficial to develop web-based decision support systems that can support symptom management at home. A mobile-compatible symptom self-management decision support system will be developed and tested with five patients, based on the needs of NHL patients, evidence-based guidelines, and expert opinions. A randomized controlled trial design with a single-blind and active control group will be applied. NHL patients will be pretested and randomized (intervention: 26, control: 26). The intervention group will use the decision support system developed for symptom self-management for three months. The researchers will share their phone numbers with the patients and be contacted via the 24/7 contact button or the phone. The effectiveness of the decision support system developed for symptom self-management is planned to be evaluated at the beginning and after 12 weeks.

Read the detailed description

Non-Hodgkin lymphoma (NHL) accounts for approximately 41% of the entire hematological cancer population. Improving symptom self-management of patients in NHL treatment and care is among the important goals. Symptom self-management in NHL patients is considered an important factor in the early detection and control of symptoms. Although treatment and care have an important role in the concept of symptom self-management in NHL patients, it is reported that the symptom self-management levels of the patients are generally low. Since NHL patients often experience disease and treatment-related side effects after discharge from the hospital, it seems necessary to develop web-based decision support systems that can support symptom management at home. Decision support system applications developed for symptom self-management; help patients manage their symptoms, coordinate treatment plans, receive comprehensive care, update their knowledge and encourage continuous learning. The study aims to evaluate the effect of the decision support system developed for symptom self-management in NHL patients on symptom management, quality of life, and unplanned hospital admissions.

In the study, a web-based decision support system for symptom self-management in NHL patients will be developed. The website content and decision support system will be prepared in line with current literature, national and international websites, and guidelines, evaluated with expert opinions and readability index, and will be finalized by testing with preliminary application. The study was designed as a randomized study with a single-blind and active control group. This study will be carried out with an NHL patient who is followed up and treated in the Hematology Outpatient Clinic and Daytime Chemotherapy Unit and meets the inclusion criteria of the sample. It will be prepared in line with the Consolidated Standard of Reporting Trials - CONSORT 2018 guidelines.

In the study, the sample size was calculated based on 80% power and 5% confidence interval on the G*POWER software package. The study will be conducted with cancer patients (n=52), 26 in the intervention group and 26 in the control group. Patients with NHL diagnosis (Diffuse Large B-Cell Lymphoma and Follicular Lymphoma), over 18 years of age, who received at least two cycles of chemotherapy, had an ECOG performance score of 0-1-2, were treated with chemotherapy for the first time due to NHL diagnosis and had no verbal communication disorder. Literate patients, have internet access, and use the internet will be included.

As a randomization method, the "block randomization method" will be chosen so that the participants in the intervention and control groups have similar characteristics. An independent researcher who was not involved in the research will be assigned to the intervention and control groups with the mobile application program. Randomization will be done in a computer environment using the http://www.r-bloggers.com/example-2014-2-block-/randomization/ website and put in opaque envelopes. After obtaining informed consent from patients who meet the inclusion criteria, pre-tests will be performed by the researcher. After the pre-tests are applied, the participants will be assigned to the groups with opaque envelopes prepared by an independent researcher. Thus, assignment bias will be prevented in the randomization process. As the participants do not know the hypothesis of the research and in which group they are, it will be ensured that the participants are blinded. For the patients in the control group not to understand the application to the intervention group, the link of the website prepared for the intervention group, which contains only information on the evaluation of symptom frequency and severity, will be opened to the patients in the control group with a password. Algorithms in the decision support system intervention protocol developed for symptom self-management to be tested in the intervention group will not be included in the website shared with the control group. Blinding the patients will be ensured by having a website that will be applied to both the intervention and control groups. Since the attempt is made by the researcher, the researcher cannot be blinded.

The decision support system designed for symptom self-management will be evaluated by experts, researchers by calculating the readability formula, and patients with NHL who will be included in the preliminary application. Pre-application will be made with NHL patients who meet the inclusion criteria and consent to participate in the study. It is aimed to make a preliminary application to 10% (n=5) of the sample. Patients who were taken into pre-application will not be included in the study.

A website for symptom self-management strategies of NHL patients will be developed. On the website, patients will be asked to evaluate the frequency and severity of symptoms with a visual analog scale. The severity of symptoms was categorized as mild, moderate, or severe in line with evidence-based guidelines; In line with the algorithms created according to the severity of the symptoms, the patients in the intervention group will be provided to use the decision support systems developed for symptom self-management. It is planned that the patients in the intervention group will use the decision support system for the evaluation of symptom frequency and severity and symptom self-management on the 3rd, 7th, and 10th days of the 3rd, 4th, and 5th chemotherapy courses. In addition, a short SMS message will be sent to the patients on the 3rd, 7th, and 10th days of the 3rd, 4th, and 5th chemotherapy cycles to remind the user of the decision support system developed for self-management. Three repeated SMS will be sent to patients who do not use the decision support system, and if the system is still not used, patients will be contacted by phone. Patients in the control group will benefit from routine hospital services for three months, and only the link of the website developed for symptom self-management strategies of NHL patients to evaluate symptom frequency and severity with a visual analog scale will be shared with patients. On the 3rd, 7th, and 10th days of the chemotherapy course, they will be asked to evaluate their symptom experience and severity. To remind the patients in the control group to evaluate the frequency and severity of symptoms, a short SMS message will be sent to the patients on the 3rd, 7th, and 10th days of the 3rd, 4th, and 5th chemotherapy cycles. In addition, the link to the "Lymphoma Patient Guide" on the Turkish Society of Hematology page for the symptom management system will be sent to the control group via SMS.

Being tested
The effectiveness of the online decision support system developed for symptom self-management, Symptom self-management with an education booklet
Keywords
Nursing, Decision Support System, Non-Hodgkin Lymphoma, Randomized Controlled Trial, Symptom Self-Management, Quality of Life
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • The effectiveness of the online decision support system developed for symptom self-managementBehavioural

    The online decision support system will appear with mild, moderate, or high severity according to symptom severity. If the patient's symptom is of mild category severity, a green area will appear on the screen and patients will see information on self-management strategies in this area. If patient's symptom is of moderate category severity, a yellow area will appear on the screen and patients will see information on self-management strategies and symptom monitoring at home in this area. In moderate symptom severity, when a yellow area occurs, patients should be asked, "Is your fever above 38℃?" according to their needs. Information about the treatment steps to be followed will be given. If the patient's symptom is in a severe category, a red area will appear on the screen and the patients will be warned to apply to the healthcare institution within this area.

  • Symptom self-management with an education bookletBehavioural

    Symptom frequency and severity level of NHL patients will be evaluated with an online web-based application. NHL patients, who will be treated with the symptom self-management with education booklet. Participants will be asked to evaluate the frequency and severity of symptoms through the online symptom evaluation system on the 3rd, 7th, and 10th days of the 3rd, 4th, and 5th chemotherapy courses for three months. They will be able to do symptom self-management within the scope of the patient education booklet sent to them via SMS.

Study groups in NCT05443165
Study groupRoleWhat they receive
Symptom self-management with an online decision support systemExperimentalSymptom frequency and severity level of NHL patients will be evaluated with an online web-based application. NHL patients, who will be applying symptom self-management with an online decision support system, will be expected to additionally manage their symptom self-management using with this system. Participants in the intervention group will be asked to evaluate the frequency and severity of symptoms through the online symptom evaluation system on the 3rd, 7th, and 10th days of the 3rd, 4th, and 5th chemotherapy courses, and to use the decision support system for symptom self-management according to symptom severity. During the follow-up period, a short SMS message will be sent to the patients on the 3rd, 7th, and 10th days of the 3rd, 4th, and 5th chemotherapy cycles. In the third month, after the follow-up phase of the study is completed, the patients in the intervention group who come to the hospital for follow-up or treatment will receive post-tests.
Receives: Behavioral: The effectiveness of the online decision support system developed for symptom self-management
Symptom self-management with an education bookletActive comparatorSymptom frequency and severity level of NHL patients will be evaluated with an online web-based application. NHL patients, who will be treated with the symptom self-management with education booklet. Participants will be asked to evaluate the frequency and severity of symptoms through the online symptom evaluation system on the 3rd, 7th, and 10th days of the 3rd, 4th, and 5th chemotherapy courses for three months. They will be able to do symptom self-management within the scope of the patient education booklet sent to them via SMS. During the follow-up period, a short SMS message will be sent to the patients on the 3rd, 7th, and 10th days of the 3rd, 4th, and 5th chemotherapy cycles. In the third month, after the follow-up phase of the study is completed, the patients in the intervention group who come to the hospital for follow-up or treatment will receive post-tests.
Receives: Behavioral: Symptom self-management with an education booklet

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 developed by De Haes et al. (1996) is used to evaluate the distress caused by the symptoms experienced by cancer patients. It consists of two sub-dimensions, Psychological and Physical Symptom. Scale items are scored on a Likert type ranging from one to four. The scale consists of 27 items in total, with the Psychological Symptom sub-dimension 8 items and the Physical Symptom sub-dimension 19 items. The Psychological Symptom subscale is the lowest 8 points, the highest 32 points, and the Physical Symptom subscale is the lowest 19 points and the highest 76 points. As the score obtained from the scale increases, the distress experienced also increases.

    Measured: 12 weeks

  2. Functional Assessment of Cancer Therapy [FACT-G (Version 4)] Quality of Life Scale

    The Functional Assessment of Cancer Therapy [FACT-G (Version 4)] Scale was developed by the "Center on Outcomes, Research and Education Northwestern Healthcare" headquartered in Evanston / Illinois in the United States, and the FACT-G (Version 4) evaluates the quality of life of malignant patients. FACT-G (Version 4) scales have been translated into many different languages. The scale items contain sentences evaluating the last week. A 5-point Likert-type scale (0: not at all, 1: very little, 2: a little, 3: quite a lot, 4: a lot) is used for the answers in the scale, which consists of 27 items. The total score is between 0-108. With FACT-G (Version 4), four dimensions of quality of life are evaluated: physical condition, social and family status, emotional status, and activity status. A high total score indicates that they perform their daily activities more.

    Measured: 12 weeks

  3. Unplanned Hospital Applications Follow-up Form

    As a result of the use of the decision support system developed for self-management of the patients in the intervention group, unplanned hospital admissions are expected to decrease. For this purpose, an Unplanned Hospital Application Form was prepared by the researchers to evaluate unplanned hospital admissions. With this form, unplanned hospital or emergency service admissions in the last three months, unplanned hospitalization, unplanned outpatient admission due to chemotherapy-related problems, and unplanned need for a new drug will be evaluated in patients with NHL in the intervention group. Each application frequency will be evaluated and the groups will be compared in this respect.

    Measured: 12 weeks

Timeline

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

  1. First posted5 Jul 2022
  2. Study start31 Jan 2024
  3. Primary completion31 Mar 2024
  4. Study completion30 Jun 2024

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
NHL patients meeting the sampling criteria will be assigned to the intervention and control groups by block randomization (1:1). NHL patients in the intervention group will be introduced to the decision support system regarding symptom self-management in face-to-face interviews. The decision support system will be asked to use it for three months on the 3rd, 7th, and 10th days of the 3rd, 4th and 5th chemotherapy cycles. A short SMS message will be sent to the patients on the 3rd, 7th, and 10th days of the 3rd, 4th and 5th chemotherapy courses. Participants will be able to contact researchers via the 24/7 contact button or by phone. In the control group, SMS will be sent to the control group on the 3rd, 7th, and 10th days after each chemotherapy to remind them about the frequency and severity of symptoms during the three-month follow-up. The "Lymphoma Patient Guide" link on the Turkish Society of Hematology page for the symptom management system will be sent to the patients via SMS.
Masking
Single blind
Who is masked
Participant
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443165
Sponsor's protocol ID
3890
Acronym
LympSCare
Status last verified
Jan 2025
First submitted
28 Jun 2022
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The effectiveness of the online decision support system developed for symptom self-management and Symptom self-management with an education booklet in people with Decision Support System and Non-Hodgkin Lymphoma, run by Akdeniz University at 1 site in Turkey (Türkiye).

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 8 inclusion and 4 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 28 Jan 2025.

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