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临床试验/NCT05443165
NCT05443165已完成不适用

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

Akdeniz University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Unplanned Hospital Applications Follow-up Form

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Participants will be divided into groups according to the randomization list created to assign each patient to a group. Two independent researchers will conduct the assignment of participants to the intervention and control groups and the evaluation of outcome measurement data. Researchers will not be blinded as they make the interventions. However, participants will be blinded because they do not know the study's hypotheses and which group they are in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • Having internet access at home, having a device such as a tablet, computer, or phone, and being able to use these tools

排除标准

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

结局指标

主要结局

Unplanned Hospital Applications Follow-up Form

时间窗: 12 weeks

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.

Rotterdam Symptom Checklist

时间窗: 12 weeks

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.

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

时间窗: 12 weeks

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Gözde SEZGİN

Principal Investigator

Akdeniz University

研究点 (2)

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