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

Sponsor
Baskent University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05609227
Collaborator
Ankara Oncology Research and Training Hospital (Other)
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12
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Study Details

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:

  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.

Condition or Disease Intervention/Treatment Phase
  • Other: mobile application
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
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.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:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of a Mobile Application Developed for Hematopoietic Stem Cell Transplant Patients on Supportive Care Needs and Quality of Life
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: mobile application

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

Other: mobile application
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.

No Intervention: Control

Participants will receive routine care.

Outcome Measures

Primary Outcome Measures

  1. quality of functionality [Baseline and 90th days]

    Functional Assessment of Cancer Therapy-Bone Marrow Transplant (4th version) (Change from baseline to the 30th and 90th days will be assessed).

  2. supportive care [Baseline and 90th days]

    James Supportive Care Screening (Change from baseline to the 30th and 90th days will be assessed).

  3. anxiety [Baseline and 90th days]

    Distress thermometer (Change from baseline to the 30th and 90th days will be assessed).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi Ankara Yenimahalle Turkey 06200

Sponsors and Collaborators

  • Baskent University
  • Ankara Oncology Research and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dila Başcı, MSc, Baskent University
ClinicalTrials.gov Identifier:
NCT05609227
Other Study ID Numbers:
  • KA21/130
First Posted:
Nov 8, 2022
Last Update Posted:
Nov 8, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dila Başcı, MSc, Baskent University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2022