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

NCT05609227 | Unknown DMC

• 1 other identifier: KA21/130
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.What is the effect of the education given with the mobile application on the quality of life of stem cell transplant patients?
2. 2.What is the effect of the education given with the mobile application on supportive care of stem cell transplant patients?
3. 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.

Conditions

Hematologic Malignancy; Patient Education

Keywords

stem cell transplantation; mobile application; bone marrow transplant; quality of life; supportive care

Outcome Measures

Primary Outcomes (3)

• 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).

  Baseline and 90th days

• supportive care

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

  Baseline and 90th days

• anxiety

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

  Baseline and 90th days

Study Arms (2)

mobile application

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants will receive routine care.

Interventions

mobile application OTHER

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.

mobile application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Being illiterate
• Patients not having a smartphone
• Patients not being able to use mobile application

Sponsors & Collaborators

• Baskent University: lead
• Ankara Oncology Research and Training Hospital: collaborator

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 32945777 BACKGROUND

• 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.

  PMID: 29112484 BACKGROUND

• 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.

  PMID: 28948360 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 8, 2022
• Study Start: March 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: March 1, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)