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Trial Title:
Effect of Mobile Application on Supportive Care Needs and Quality of Life Patients Undergoing Hematopoietic Stem Cell Transplantation
NCT ID:
NCT05609227
Condition:
Hematologic Malignancy
Patient Education
Conditions: Official terms:
Hematologic Neoplasms
Conditions: Keywords:
stem cell transplantation
mobile application
bone marrow transplant
quality of life
supportive care
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants will be stratified according to type of planned transplantation by
preparatory outpatient clinic nurse; then will randomly assigned to two groups either
intervention or control. The intervention group will get a mobile application developed
compatible with IOS or android systems, containing information about the stem cell
transplantation process, stem cell transplantation and nutrition, lifestyle
recommendations, and answering possible questions of the patients and their relatives.
The control group will receive standard care. The data of both groups will be collected
on the first day of hospitalization, at controls during the first and third month.
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
mobile application
Description:
The application, compatible with IOS and android systems for patients candidate for stem
cell transplantation, could be applied whenever needed information relating to
transplantation process.
Arm group label:
mobile application
Summary:
The aim of this interventional study is to determine the effect of the mobile application
on quality of life and supportive care in patient undergoing stem cell
transplantation.The main questions it aims to answer are:
1. What is the effect of the education given with the mobile application on the quality
of life of stem cell transplant patients?
2. What is the effect of the education given with the mobile application on supportive
care of stem cell transplant patients?
3. What is the effect of the education given with the mobile application on anxiety
levels of stem cell transplant patients? In the study, patients will be randomized
into the group in which standard processes are applied and the group trained by the
mobile application.
Detailed description:
Stem cell transplantation has been used for more than 50 years in the treatment of
malignant and benign hematological diseases and some solid tumors. The stem cell
transplant preparation process is a complex treatment that requires close follow-up in
the hospital and after the transplant. Studies indicate that patients experience more
intense worry and anxiety during the transplant process. Nursing care during the
transplant period includes factors such as oral care, nutrition, mobilization, taking
preventive measures against complications associated with neutropenia and
thrombocytopenia, and these interventions have a positive effect on the patient's quality
of life. Aim of this study is to determine the effect of the mobile application on
quality of life and supportive care in patient undergoing stem cell transplantation. In
the study, patients will be randomized into the group in which standard processes are
applied and the group trained by the mobile application. Functional assessment scale
(FACT-BMT), James Supportive Care and Needs Assessment Scale in Cancer Patients and
Hospital Anxiety and Depression Scale were planned to be administered to both groups on
the day of hospitalization and discharge day, and 3rd month follow up. The mobile
application content will consist of 3 modules: information about the stem cell
transplantation process, stem cell transplantation and nutrition, lifestyle
recommendations, and answering possible questions of the patients and their relatives. At
the end of the study, the test results of the patient groups will be compared both within
themselves and with each other. The effects of standard and mobile application training
on the test results of the patients and whether the results of the group receiving mobile
application training differ from the standard training group will be investigated.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients undergoing hematopoietic stem cell transplantation (autologous or
allogeneic) for the first time
- Patients aged18 years or older,
- Patients able to communicate in Turkish as well as reading and writing.
- Those whose physical and mental conditions are suitable for participating in the
research,
- Patients volunteered to participate in the study.
Exclusion Criteria:
- Being illiterate
- Patients not having a smartphone
- Patients not being able to use mobile application
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
Address:
City:
Ankara
Zip:
06200
Country:
Turkey
Start date:
March 1, 2022
Completion date:
March 1, 2023
Lead sponsor:
Agency:
Baskent University
Agency class:
Other
Collaborator:
Agency:
Ankara Oncology Research and Training Hospital
Agency class:
Other
Source:
Baskent University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05609227