Clinical trial NCT06552494: Developing and Testing an Integrated mHealth Learning Program for Gynecological Cancer
Official title: Developing and Testing an Integrated mHealth Learning Program for Gynecological Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mobile Health
Keywords: gynecological cancer
mobile health
mobile health learning
mHealth application
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 utilize 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.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Symptom Distress
timeFrame: Data were collected at baseline.
measure: Symptom Distress
timeFrame: Data were collected at 1 months after the Interventions.
measure: Symptom Distress
timeFrame: Data were collected at 3 months after the Interventions.
measure: Communication and Attitudinal Self-Efficacy for cancer
timeFrame: Data were collected at baseline.
measure: Communication and Attitudinal Self-Efficacy for cancer
timeFrame: Data were collected at 1 months after the Interventions.
measure: Communication and Attitudinal Self-Efficacy for cancer
timeFrame: Data were collected at 3 months after the Interventions.
measure: Needs of Health Information for the patients with Gynecological Cancer
timeFrame: Data were collected at baseline.
measure: Needs of Health Information for the patients with Gynecological Cancer
timeFrame: Data were collected at 1 months after the Interventions.
measure: Needs of Health Information for the patients with Gynecological Cancer
timeFrame: Data were collected at 3 months after the Interventions.
measure: Chatbot Usability
timeFrame: Data were collected at baseline.
measure: Chatbot Usability
timeFrame: Data were collected at 1 months after the Interventions.
measure: Chatbot Usability
timeFrame: Data were collected at 3 months after the Interventions.
measure: System Usability
timeFrame: Data were collected at baseline.
measure: System Usability
timeFrame: Data were collected at 1 months after the Interventions.
measure: System Usability
timeFrame: Data were collected at 3 months after the Interventions.
measure: mHealth App Usability
timeFrame: Data were collected at baseline.
measure: mHealth App Usability
timeFrame: Data were collected at 1 months after the Interventions.
measure: mHealth App Usability
timeFrame: Data were collected at 3 months after the Interventions.
measure: Bot Usability
timeFrame: Data were collected at baseline.
measure: Bot Usability
timeFrame: Data were collected at 1 months after the Interventions.
measure: Bot Usability
timeFrame: Data were collected at 3 months after the Interventions.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Cheng Gung Memorial Hospital
state: Guishan Dist.
Study officials:
affiliation: Chang Gung University
name: Jian Tao LEE, Professor
role: PRINCIPAL_INVESTIGATOR
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