Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05443165 |
| Other study ID # |
3890 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 31, 2024 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Akdeniz University |
| Contact |
Merve Gozde Sezgin, MSc, RN |
| Phone |
+90 242 3102981 |
| Email |
gozdesezgin1990[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
