Clinical Trials Directory

Trials / Completed

CompletedNCT06552494

Developing and Testing an Integrated mHealth Learning Program for Gynecological Cancer

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
67 (actual)
Sponsor
Chang Gung Memorial Hospital · Academic / Other
Sex
Female
Age
20 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The purpose of this project is to develop and test an integrated mHealth learning program (L-mHealth program) for gynecological cancer that integrates effective educational strategies and mobile health application to meet the learning needs of Taiwanese Women with Gynecological Cancer (WGC) through the process of co-creation, with the active input of WGC and experts' directly impacting content and design. This project was to develop the L-mHealth system and prototype of a smartphone app for WGC through the process of co-creation, with the active input of WGC and experts' directly impacting content and design.

Detailed description

The second year research purpose is to establish the L-mHealth program's framework, which according to the needs assessment and health education strategies of the first year. The L-mHealth system will be then developed according to the course framework use TTM theory and self-efficacy theory as the basis. A single-blinded, randomized controlled parallel-group clinical trial with repeated- measures research will be conducted in the third year. A total of 120 ovarian cancer women will be recruited from a medical center in northern Taiwan and then assigned to one of two groups (the experiment and control groups) by stratified randomization. Women were randomized either to the intervention group (n=60) receiving the L-mHealth program plus care as usual or the control group (n=60) receiving care as usual alone. Data will be collected at baseline (T0), 1 months (T1) and 3 months (T2) after the intervention. Co-creation is a user-involved process that can create a useful and customized product for the WGC target population. As such, this process is a beneficial process to tilize when addressing the specific needs of WGC. Through the study of the L-mHealth program, it is expected to improve women's use of ICT and demonstrate its potential as an effective and easily accessible intervention to promote women's symptom interference and quality of life for WGC.

Conditions

Interventions

TypeNameDescription
OTHERL-mHealth programThe intervention group receiving the L-mHealth program plus care as usual. Data will be collected at baseline (T0), 1 months (T1) and 3 months (T2) after the intervention.

Timeline

Start date
2020-10-16
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2024-08-14
Last updated
2026-03-23

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT06552494. Inclusion in this directory is not an endorsement.