Clinical trial NCT05609227: Effect of Mobile Application on Supportive Care Needs and Quality of Life Patients Undergoing Hematopoietic Stem Cell Transplantation
Official title: Effect of a Mobile Application Developed for Hematopoietic Stem Cell Transplant Patients on Supportive Care Needs and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Malignancy
Patient Education
Keywords: stem cell transplantation
mobile application
bone marrow transplant
quality of life
supportive care
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Ankara Oncology Research and Training Hospital
First posted: 2022-11-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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

Primary outcomes:
measure: quality of functionality
timeFrame: Baseline and 90th days
measure: supportive care
timeFrame: Baseline and 90th days
measure: anxiety
timeFrame: Baseline and 90th days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
state: Yenimahalle
Study officials:
References:
citation: Rozwadowski M, Dittakavi M, Mazzoli A, Hassett AL, Braun T, Barton DL, Carlozzi N, Sen S, Tewari M, Hanauer DA, Choi SW. Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 18;9(9):e19288. doi: 10.2196/19288.
citation: Larson JL, Rosen AB, Wilson FA. The Effect of Telehealth Interventions on Quality of Life of Cancer Patients: A Systematic Review and Meta-Analysis. Telemed J E Health. 2018 Jun;24(6):397-405. doi: 10.1089/tmj.2017.0112. Epub 2017 Nov 7.
citation: Moradian S, Voelker N, Brown C, Liu G, Howell D. Effectiveness of Internet-based interventions in managing chemotherapy-related symptoms in patients with cancer: a systematic literature review. Support Care Cancer. 2018 Feb;26(2):361-374. doi: 10.1007/s00520-017-3900-8. Epub 2017 Sep 25.