Effect on Adaptation to Cancer of Mobile Application Developed for Gynecological Cancer Patients

NCT ID: NCT05131490

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2023-02-15

Brief Summary

Getting a cancer diagnosis, the difficult treatments applied and the side effects that occur completely affect the life of the patient, shaking his future plans and adaptation mechanisms. In recent years, the role of healthcare professionals has included counseling and promoting positive health behaviors to reduce disease and treatment side effects and increase adherence to disease. The service provided by healthcare professionals to patients has started to move to digital environments with the developing technology and the concept of e-health has been born. Offering e-health support as part of regular care has become a powerful tool to help cancer patients manage their disease. Web-based interventions or mobile applications provide an opportunity for improved communication and better information exchange between healthcare professionals and patients. In addition, education of cancer patients and patient self-management allow for better clinical outcomes using e-health or mobile health applications. The widespread use of smartphones enables cancer patients to be supported from different perspectives through mobile applications. When the studies are examined, it is noteworthy that mobile applications developed for female cancer patients are predominantly related to breast cancer. Most of the technology-based researches on gynecological cancers are studies conducted through text message intervention, online web-based interventions or social media tools such as Facebook and WeChat. For this reason, the aim of this study is to develop a mobile application to increase physical and psychosocial adjustment for gynecological cancer patients receiving chemotherapy and to investigate its effectiveness.

Detailed Description

This study was planned as a parallel, single-blind, pre-post-test randomized controlled experimental study in which two groups (experiment-control) will be compared. The block randomization method will be used. The patients who will participate in the research will be reached through social media networks related to cancer (Facebook and Instagram account of the Dance with Cancer Association, etc.) and the data will be collected from patients who are suitable for the sample characteristics through mobile application. The sample size was calculated in the G*power statistics program by utilizing the data of a study in which on cancer patients using a mobile application intervention was previously performed (α =0.05, d=0.75). Accordingly, it was found that 23 people should be taken for each group to sampling for 80% power. Considering that there might be losses, the number of samples was increased by 10% and it was planned to include a total of 52 people in the study. Intention-to-treat analysis will be performed to manage bias and losses.

A pilot application will be conducted for 4 weeks with 6 patients regarding the usability of the mobile application and these patients will not be included in the study. At the end of 4 weeks, feedback will be received from the patients participating in the pilot application with the mobile application evaluation form. Necessary changes will be made in the mobile application in line with the feedback.

Conditions

Gynecologic Cancer; Chemotherapy Effect; Mobile Application; Physiological Adaptation; Psychosocial Adaptation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental

Experimental group intervention consists two months a mobile application intervention developed for gynecological cancer patients receiving chemotherapy

Group Type: EXPERIMENTAL

A mobile application intervention developed for gynecological cancer patients receiving chemotherapy

Intervention Type: BEHAVIORAL

The mobile application will consist of modules. It is planned to include four education modules and consultancy modules in the application.

1. Module 1: It will consist of sub-categories with information to be prepared in line with the current literature on gynecological cancer types and treatments applied. There will be information and short videos that will strengthen coping with physical symptoms, especially from chemotherapy.

2. Module 2: In this area, there will be meditation and relaxation/breathing exercises, information on relaxing complementary therapies, anxiety reduction and stress management techniques videos and audio recordings.

3. Module 3: Current developments on gynecological cancers will be included.

4. Module 4: Encouraging recovery stories and videos of cancer survivors will be included.

5. Module 5: Counseling module. This is the area where patients who cannot find answers in the frequently asked questions section can ask questions to the research team.

No intervention

Control group receive routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

A mobile application intervention developed for gynecological cancer patients receiving chemotherapy

The mobile application will consist of modules. It is planned to include four education modules and consultancy modules in the application.

1. Module 1: It will consist of sub-categories with information to be prepared in line with the current literature on gynecological cancer types and treatments applied. There will be information and short videos that will strengthen coping with physical symptoms, especially from chemotherapy.

2. Module 2: In this area, there will be meditation and relaxation/breathing exercises, information on relaxing complementary therapies, anxiety reduction and stress management techniques videos and audio recordings.

3. Module 3: Current developments on gynecological cancers will be included.

4. Module 4: Encouraging recovery stories and videos of cancer survivors will be included.

5. Module 5: Counseling module. This is the area where patients who cannot find answers in the frequently asked questions section can ask questions to the research team.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Be over 18 years old
• Be at least primary school graduate
• Volunteering to participate in research
• Being diagnosed with gynecological cancer for the first time (no cancer recurrence)
• Receiving at least one course of chemotherapy and continuing chemotherapy treatment
• Be Eastern Cooperative Oncology Group (ECOG) performance scale score below 3
• Be not have a psychiatric illness
• Owning a smartphone
• Be have internet access and have used any mobile application before

Exclusion Criteria

• Be have any psychiatric illness
• Be have not yet received or completed chemotherapy treatment
• Be Eastern Cooperative Oncology Group (ECOG) performance scale score of 3 and above

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Okan Vardar

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

60116787-020/34123

Identifier Type: -

Identifier Source: org_study_id