Clinical trial NCT05131490: Effect on Adaptation to Cancer of Mobile Application Developed for Gynecological Cancer Patients
Official title: Effect on Physical and Psychosocial Adaptation of Mobile Application Developed for Gynecological Cancer Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Chemotherapy Effect
Mobile Application
Physiological Adaptation
Psychosocial Adaptation
Keywords: Gynecologic Cancer
Chemotherapy Effect
Mobile Application
Physiological Adaptation
Psychosocial Adaptation
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind pre-post test randomized controlled design
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The Psychosocial Adjustment to İllnes Scale-Self Report (PAIS-SR)
timeFrame: Change from baseline PAIS-SR score at 4 and 8 weeks
measure: MD Anderson Symptom Inventory (MDASI)
timeFrame: Change from baseline MDASI score at 4 and 8 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline HADS score at 4 and 8 weeks
measure: Assessment of Survivor Concerns (ASC)
timeFrame: Change from baseline ASC score at 4 and 8 weeks
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline
measure: Mobile Application Evaluation Form
timeFrame: At the end of the 4-week pilot application
measure: Introductory Information Form
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: