Developing and Testing an Integrated mHealth Learning Program for Gynecological Cancer

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Mobile Health

Treatments: Other: L-mHealth program

Study type: Interventional

Funder types: Other

Identifiers

NCT06552494

109-2629-H-182-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women definitively or suspected to be diagnosed with ovarian cancer, with the cancer staged at Stage 3 or below.
2. Women receiving surgery, chemotherapy, or immunotherapy at the recruiting hospital.

3.20 to 70 years old. 4.Possesses and is able to use an internet-enabled mobile device (such as a smartphone or tablet).

5.Able to clearly communicate and read/write in Mandarin or Taiwanese. 6.Agrees to participate in the study and signs the informed consent form.

Exclusion criteria

1. History of other malignant tumors.
2. Intellectual disability or mental disorders.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

The intervention group

Experimental group

Description:

The intervention group will receive the L-mHealth program along with routine care, which includes the "L-mHealth APP" This app is complemented by an "Online Community Support System" and the "LINE Instant Messaging Software."

Treatment:

Other: L-mHealth program

The control group

No Intervention group

Description:

The control group receiving care as usual alone.