Effects of Symptom Management Education With Mobile Application in Gynecological Cancer Patients Receiving Chemotherapy

NCT06713122 | Enrolling By Invitation

• 1 other identifier: 2024-442
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Gynaecological cancers, which have an important place among the cancers seen both in the world and in our country. Chemotherapy, which is one of the most commonly used and basic methods in cancer treatment, causes many physical and psychological side effects while treating the disease. It is very important to identify the symptoms experienced, evaluate, control and provide professional health guidance. The spread of digitalisation has turned mobile learning into a kind of need or necessity rather than a preference. Increases the control of individuals over themselves and provides self-discipline. The aim of this study was to evaluate the effect of symptom management training given with an artificial intelligence supported mobile application on supportive care needs, symptom severity and psychological well-being of gynaecological cancer patients receiving chemotherapy. The study was planned as a randomised controlled trial. The population of the study will consist of patients who applied to Etlik City Hospital-Oncology Hospital-Day Outpatient Unit for the first time to receive chemotherapy treatment for gynaecological cancer and completed the first course. The study will be conducted with a total of 70 patients, including 35 patients from the intervention group and 35 patients from the control group. Research Hypotheses: Gynaecological cancer patients receiving chemotherapyBetween the intervention group receiving symptom management training with a mobile application and the control group receiving standard care;

1. 1.H1: There is a difference in terms of the severity of symptoms experienced.
2. 2.H2: There is a difference in terms of supportive care needs.
3. 3.H3: There is a difference in terms of psychological well-being levels. Data Collection Tools Descriptive Information Form, Edmonton Symptom Diagnostic Scale, Supportive Care Needs Scale, Psychological Well-Being Scale and Eastern Cooperative Oncology Group (ECOG) Performance Scale will be used as data collection tools.

Conditions

Gynaecological Cancer; Chemotherapy; Nursing Care

Keywords

Gynaecological cancer; chemotherapy; mobile application; nursing care; psychological well-being; supportive care needs

Outcome Measures

Primary Outcomes (3)

• Supportive Care Needs

  Supportive Care Needs Scale:Each question in the scale is numbered from 1 to 5 and 1 point corresponds to 'I did not experience this situation' and 5 points correspond to 'I needed a lot of support'

  Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)

• Symptom Severity

  Edmonton Symptom Diagnostic Scale: The severity of each symptom is assessed with numerical numbers from 0 to 10. A score of 0 indicates that the symptom is absent and a score of 10 indicates that the symptom is felt very severely.

  Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)

• Psychological Well-Being

  Psychological Well-Being Scale: The items of the Psychological Well-Being Scale are answered between 1-7 in the form of strongly disagree (1) and strongly agree (7). Scores vary between 8 and 56. A high score indicates that the person has many psychological resources and strengths.

  Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)

Study Arms (2)

İntervention Group- Group receiving Symptom Management Training with Mobile Application

EXPERIMENTAL

Mobile application intervention will be applied to the intervention group. The evaluation tests will be repeated after the first cycle of chemotherapy treatment, at the 3rd and 5th cycles.

Behavioral: İntervention Group- Group receiving Symptom Management Training with Mobile Application

Control Group

NO INTERVENTION

No intervention will be applied to the control group. The evaluation tests will be repeated after the first cycle of chemotherapy treatment, at the 3rd and 5th cycles.

Interventions

İntervention Group- Group receiving Symptom Management Training with Mobile Application BEHAVIORAL

The application to be developed in the research will be both Android and IOS supported. Monitoring the active use of the patients from the interface by the researcher and receiving individual and collective notifications in line with the profile that the patients receiving chemotherapy will create in the application will increase the usability of the application. Thus, the benefit that users receive after active use can be determined. The content of the Let's fight the symptoms together module will be created by experts in the field and people will be able to actively use these methods while struggling with the symptoms they experience. Patients may not always have the opportunity to reach a nurse or health professional. In symptom management with the mobile application, artificial intelligence will be trained by the researcher and integrated into the application will help patients reach the right information without wasting time.

İntervention Group- Group receiving Symptom Management Training with Mobile Application

Eligibility Criteria

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

You may qualify if:

• Receiving chemotherapy for the first time due to gynaecological cancer and completing the first chemotherapy course
• At least 18 years old
• Not previously diagnosed with cancer, diagnosed with gynaecological cancer for the first time and only
• Literate
• Who agreed to participate in the research
• No communication barrier
• Eastern Cooperative Oncology Group (ECOG) Performance Scale score below 3
• No diagnosed psychiatric illness
• Women who have an Android or IOS smartphone and can access the internet

You may not qualify if:

• The investigator discontinued the treatment
• Chemotherapy treatment discontinued after the start of the study
• Not actively using the mobile application
• Not filling in the forms during the use of the Mobile Application
• The occurrence of another cancer during the research

Sponsors & Collaborators

• Esra Nur Erdoğan: lead

Study Sites (1)

Etlik City Hospital-Oncology Hospital-Day Outpatient Unit

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Graetz I, Anderson JN, McKillop CN, Stepanski EJ, Paladino AJ, Tillmanns TD. Use of a web-based app to improve postoperative outcomes for patients receiving gynecological oncology care: A randomized controlled feasibility trial. Gynecol Oncol. 2018 Aug;150(2):311-317. doi: 10.1016/j.ygyno.2018.06.007. Epub 2018 Jun 11.

  PMID: 29903391 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Esra Nur Erdoğan, PhD Student

  University of Health Sciences Gulhane Faculty of Nursing, Department of Obstetrics and Gynaecology

  STUDY CHAIR

• Gülten Güvenç, Prof.Dr.

  University of Health Sciences Gulhane Faculty of Nursing, Department of Obstetrics and Gynaecology

  PRINCIPAL INVESTIGATOR

• Tülay Eren, Asst. Prof.

  Etlik City Hospital, Medical Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Investigator, PhD Student, Research Assistant

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: December 3, 2024
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 2, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After the end of the study

Locations

TU (1)