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Effect of Mobile Application on Supportive Care Needs and Quality of Life Patients Undergoing Hematopoietic Stem Cell Transplantation

Primary Purpose

Hematologic Malignancy, Patient Education

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mobile application
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematologic Malignancy focused on measuring stem cell transplantation, mobile application, bone marrow transplant, quality of life, supportive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mobile application

Control

Arm Description

Participants will get a mobile application containing information about information about all stages of stem cell transplantation process (pre, during and post).

Participants will receive routine care.

Outcomes

Primary Outcome Measures

quality of functionality
Functional Assessment of Cancer Therapy-Bone Marrow Transplant (4th version) (Change from baseline to the 30th and 90th days will be assessed).
supportive care
James Supportive Care Screening (Change from baseline to the 30th and 90th days will be assessed).
anxiety
Distress thermometer (Change from baseline to the 30th and 90th days will be assessed).

Secondary Outcome Measures

Full Information

First Posted
October 27, 2022
Last Updated
November 1, 2022
Sponsor
Baskent University
Collaborators
Ankara Oncology Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05609227
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
Collaborators
Ankara Oncology Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: What is the effect of the education given with the mobile application on the quality of life of stem cell transplant patients? What is the effect of the education given with the mobile application on supportive care of stem cell transplant patients? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy, Patient Education
Keywords
stem cell transplantation, mobile application, bone marrow transplant, quality of life, supportive care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mobile application
Arm Type
Experimental
Arm Description
Participants will get a mobile application containing information about information about all stages of stem cell transplantation process (pre, during and post).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive routine care.
Intervention Type
Other
Intervention Name(s)
mobile application
Intervention 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.
Primary Outcome Measure Information:
Title
quality of functionality
Description
Functional Assessment of Cancer Therapy-Bone Marrow Transplant (4th version) (Change from baseline to the 30th and 90th days will be assessed).
Time Frame
Baseline and 90th days
Title
supportive care
Description
James Supportive Care Screening (Change from baseline to the 30th and 90th days will be assessed).
Time Frame
Baseline and 90th days
Title
anxiety
Description
Distress thermometer (Change from baseline to the 30th and 90th days will be assessed).
Time Frame
Baseline and 90th days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
City
Ankara
State/Province
Yenimahalle
ZIP/Postal Code
06200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
PubMed Identifier
32945777
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.
Results Reference
background
PubMed Identifier
29112484
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.
Results Reference
background
PubMed Identifier
28948360
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.
Results Reference
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Effect of Mobile Application on Supportive Care Needs and Quality of Life Patients Undergoing Hematopoietic Stem Cell Transplantation

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