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

NCT05443165 | Completed

• 1 other identifier: 3890
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Decision Support System; Non-Hodgkin Lymphoma

Keywords

Nursing; Decision Support System; Non-Hodgkin Lymphoma; Randomized Controlled Trial; Symptom Self-Management; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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.

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

Study Arms (2)

Symptom self-management with an online decision support system

EXPERIMENTAL

Symptom 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.

Behavioral: The effectiveness of the online decision support system developed for symptom self-management

Symptom self-management with an education booklet

ACTIVE COMPARATOR

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. 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.

Behavioral: Symptom self-management with an education booklet

Interventions

The effectiveness of the online decision support system developed for symptom self-management BEHAVIORAL

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 online decision support system

Symptom self-management with an education booklet BEHAVIORAL

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.

Symptom self-management with an education booklet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz Üniversitesi

Antalya, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 5, 2022
• Study Start: January 31, 2024
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)