Mobile HealthNCT06552494

Developing and Testing an Integrated mHealth Learning Program for Gynecological Cancer

A study testing L-mHealth program in people with Mobile Health, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 70 years, women only
Conditions the study is for: Mobile Health
What is being tested?: L-mHealth program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteTaiwan
Study dates: 16 Oct 2020to 31 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women definitively or suspected to be diagnosed with ovarian cancer, with the cancer staged at Stage 3 or below.
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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Cheng Gung Memorial Hospital
Taoyuan, Guishan Dist., 333

Other trials in Taiwan

About this study

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.

Read the 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: Mobile Health
Being tested: L-mHealth program
Keywords: gynecological cancer, mobile health, mobile health learning, mHealth application

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

L-mHealth programOther
The 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.

Study groups in NCT06552494
Study group	Role	What they receive
The intervention group	Experimental	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." Receives: Other: L-mHealth program
The control group	No intervention	The control group receiving care as usual alone.

What is being measured

The primary outcome is the main question the study is designed to answer.

Symptom Distress
The research project assessed changes in symptom distress by Symptom Distress Scale-Chinese Modified Form (SDS-CMF) .
Symptom Distress Scale-Chinese Modified Form (SDS-CMF), revised by Lai (1998), for the symptom assessment of ovarian cancer patients. The scale is adapted from the Symptom Distress Scale (SDS) developed by McCorkle and Young (1978) for lung cancer patients. The scoring method uses a 5-point Likert scale to assess the level of symptom distress as self-reported by cancer patients. A score of 1 indicates no distress at all, 2 indicates mild distress, 3 indicates moderate distress, 4 indicates severe distress, and 5 indicates very severe distress. The total score ranges from 25 to 125, with higher scores indicating more severe symptom distress. The Cronbach's alpha value for cervical cancer patients in our country was 0.87, and the content validity was 0.92 (Chen et al., 2007).
Measured: Data were collected at baseline.
Symptom Distress
The research project assessed changes in symptom distress by Symptom Distress Scale-Chinese Modified Form (SDS-CMF) .
Symptom Distress Scale-Chinese Modified Form (SDS-CMF), revised by Lai (1998), for the symptom assessment of ovarian cancer patients. The scale is adapted from the Symptom Distress Scale (SDS) developed by McCorkle and Young (1978) for lung cancer patients. The scoring method uses a 5-point Likert scale to assess the level of symptom distress as self-reported by cancer patients. A score of 1 indicates no distress at all, 2 indicates mild distress, 3 indicates moderate distress, 4 indicates severe distress, and 5 indicates very severe distress. The total score ranges from 25 to 125, with higher scores indicating more severe symptom distress.The Cronbach's alpha value for cervical cancer patients in our country was 0.87, and the content validity was 0.92 (Chen et al., 2007).
Measured: Data were collected at 1 months after the Interventions.
Symptom Distress
The research project assessed changes in symptom distress by Symptom Distress Scale-Chinese Modified Form (SDS-CMF).
Symptom Distress Scale-Chinese Modified Form (SDS-CMF), revised by Lai (1998), for the symptom assessment of ovarian cancer patients. The scale is adapted from the Symptom Distress Scale (SDS) developed by McCorkle and Young (1978) for lung cancer patients. The scoring method uses a 5-point Likert scale to assess the level of symptom distress as self-reported by cancer patients. A score of 1 indicates no distress at all, 2 indicates mild distress, 3 indicates moderate distress, 4 indicates severe distress, and 5 indicates very severe distress. The total score ranges from 25 to 125, with higher scores indicating more severe symptom distress. The Cronbach's alpha value for cervical cancer patients in our country was 0.87, and the content validity was 0.92 (Chen et al., 2007).
Measured: Data were collected at 3 months after the Interventions.
Communication and Attitudinal Self-Efficacy for cancer
The research project assessed changes in communication and attitudinal self-efficacy for cancer by Communication and Attitudinal Self-Efficacy scale for cancer (CASE).
The "Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE)," originally designed by Wolf et al. (2005) and translated by Yang (2005). The scale comprises three major dimensions: the ability to understand and participate in care, the ability to maintain a positive attitude, and the ability to seek and obtain information, totaling 12 items. The scoring uses a Likert scale, ranging from strongly disagree (1 point) to strongly agree (5 points). The reliability of the scale, as measured by internal consistency, shows a Cronbach's α value ranging from 0.80 to 0.95 across the different dimensions.
Measured: Data were collected at baseline.
Communication and Attitudinal Self-Efficacy for cancer
The research project assessed changes in communication and attitudinal self-efficacy for cancer by Communication and Attitudinal Self-Efficacy scale for cancer (CASE) .
The "Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE)," originally designed by Wolf et al. (2005) and translated by Yang (2005). The scale comprises three major dimensions: the ability to understand and participate in care, the ability to maintain a positive attitude, and the ability to seek and obtain information, totaling 12 items. The scoring uses a Likert scale, ranging from strongly disagree (1 point) to strongly agree (5 points). The reliability of the scale, as measured by internal consistency, shows a Cronbach's α value ranging from 0.80 to 0.95 across the different dimensions.
Measured: Data were collected at 1 months after the Interventions.
Communication and Attitudinal Self-Efficacy for cancer
The research project assessed changes in communication and attitudinal self-efficacy for cancer by Communication and Attitudinal Self-Efficacy scale for cancer (CASE).
The "Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE)," originally designed by Wolf et al. (2005) and translated by Yang (2005). The scale comprises three major dimensions: the ability to understand and participate in care, the ability to maintain a positive attitude, and the ability to seek and obtain information, totaling 12 items. The scoring uses a Likert scale, ranging from strongly disagree (1 point) to strongly agree (5 points). The reliability of the scale, as measured by internal consistency, shows a Cronbach's α value ranging from 0.80 to 0.95 across the different dimensions.
Measured: Data were collected at 3 months after the Interventions.
Needs of Health Information for the patients with Gynecological Cancer
The research project assessed changes in needs of health information for the patients with gynecological cancer by Informational Needs Questionnaires- Gynecological Cancer.
The study utilizes the Chinese version of Informational Needs Questionnaires- Gynecological Cancer, adapted by Lei, Har, \& Abdullah (2011) from the "Toronto Informational Needs Questionnaire-Breast Cancer (TINQ-BC)," and used with the authors' permission (Huang \& Hsieh, 2015). The Chinese version for gynecologic cancer patients was modified from 52 to 50 items, with a scoring system ranging from 1 ('Not needed at all') to 5 ('Greatly needed'). Higher scores indicate a greater need for the information in that item. The Cronbach's alpha coefficients for the subscales range from 0.835 to 0.958 (Chen \& Hsieh, 2017). The Content Validity Index (CVI) values for expert validity range from 0.75 to 0.94 (Hsieh et al., 2018; Huang \& Hsieh, 2015)."
Measured: Data were collected at baseline.
Needs of Health Information for the patients with Gynecological Cancer
The research project assessed changes in needs of health information for the patients with gynecological cancer by Informational Needs Questionnaires- Gynecological Cancer .
The study utilizes the Chinese version of Informational Needs Questionnaires- Gynecological Cancer, adapted by Lei, Har, \& Abdullah (2011) from the "Toronto Informational Needs Questionnaire-Breast Cancer (TINQ-BC)," and used with the authors' permission (Huang \& Hsieh, 2015). The Chinese version for gynecologic cancer patients was modified from 52 to 50 items, with a scoring system ranging from 1 ('Not needed at all') to 5 ('Greatly needed'). Higher scores indicate a greater need for the information in that item.The Cronbach's alpha coefficients for the subscales range from 0.835 to 0.958 (Chen \& Hsieh, 2017). The Content Validity Index (CVI) values for expert validity range from 0.75 to 0.94 (Hsieh et al., 2018; Huang \& Hsieh, 2015)."
Measured: Data were collected at 1 months after the Interventions.
Needs of Health Information for the patients with Gynecological Cancer
The research project assessed changes in needs of health information for the patients with gynecological cancer by Informational Needs Questionnaires- Gynecological Cancer.
The study utilizes the Chinese version of Informational Needs Questionnaires- Gynecological Cancer, adapted by Lei, Har, \& Abdullah (2011) from the "Toronto Informational Needs Questionnaire-Breast Cancer (TINQ-BC)," and used with the authors' permission (Huang \& Hsieh, 2015). The Chinese version for gynecologic cancer patients was modified from 52 to 50 items, with a scoring system ranging from 1 ('Not needed at all') to 5 ('Greatly needed'). Higher scores indicate a greater need for the information in that item. The Cronbach's alpha coefficients for the subscales range from 0.835 to 0.958 (Chen \& Hsieh, 2017). The Content Validity Index (CVI) values for expert validity range from 0.75 to 0.94 (Hsieh et al., 2018; Huang \& Hsieh, 2015)."
Measured: Data were collected at 3 months after the Interventions.
Chatbot Usability
The research project assessed changes in chatbot usability by Chatbot Usability Questionnaire (CUQ).
The Chatbot Usability Questionnaire (CUQ) was developed by Holmes et al. (2019) based on principles of user experience with chatbots. It is similar in design to the System Usability Scale (SUS) by Brooke (1996) but was specifically developed for assessing chatbot usability. The questionnaire consists of 16 items, with 8 related to positive aspects of chatbot usability and 8 related to negative aspects. It uses a 5-point Likert scale for users to rate the chatbot's usability, where 1 indicates strong disagreement, 2 disagreement, 3 neutrality, 4 agreement, and 5 strong agreement. The scores are standardized on a scale of 100 points.The Chatbot Usability Questionnaire (CUQ) demonstrates good internal consistency (r > 0.7) (Holmes et al., 2023).
Measured: Data were collected at baseline.
Chatbot Usability
The research project assessed changes in chatbot usability by Chatbot Usability Questionnaire (CUQ) .
The Chatbot Usability Questionnaire (CUQ) was developed by Holmes et al. (2019) based on principles of user experience with chatbots. It is similar in design to the System Usability Scale (SUS) by Brooke (1996) but was specifically developed for assessing chatbot usability. The questionnaire consists of 16 items, with 8 related to positive aspects of chatbot usability and 8 related to negative aspects. It uses a 5-point Likert scale for users to rate the chatbot's usability, where 1 indicates strong disagreement, 2 disagreement, 3 neutrality, 4 agreement, and 5 strong agreement. The scores are standardized on a scale of 100 points. The Chatbot Usability Questionnaire (CUQ) demonstrates good internal consistency (r > 0.7) (Holmes et al., 2023).
Measured: Data were collected at 1 months after the Interventions.
Chatbot Usability
The research project assessed changes in chatbot usability by Chatbot Usability Questionnaire (CUQ) from baseline to 3 months after the Interventions.
The Chatbot Usability Questionnaire (CUQ) was developed by Holmes et al. (2019) based on principles of user experience with chatbots. It is similar in design to the System Usability Scale (SUS) by Brooke (1996) but was specifically developed for assessing chatbot usability. The questionnaire consists of 16 items, with 8 related to positive aspects of chatbot usability and 8 related to negative aspects. It uses a 5-point Likert scale for users to rate the chatbot's usability, where 1 indicates strong disagreement, 2 disagreement, 3 neutrality, 4 agreement, and 5 strong agreement. The scores are standardized on a scale of 100 points.The Chatbot Usability Questionnaire (CUQ) demonstrates good internal consistency (r > 0.7) (Holmes et al., 2023).
Measured: Data were collected at 3 months after the Interventions.
System Usability
The research project assessed changes in system usability by System Usability Scale (SUS) .
The System Usability Scale (SUS), originally proposed by Brooke in 1986 (Brooke, 1996). The SUS consists of 10 items, scored using a 5-point Likert scale, with options ranging from strongly agree to strongly disagree. Strongly agree is scored as 5 points, and strongly disagree as 1 point. For positively worded items, the score is calculated by subtracting 1 from the item score, while for negatively worded items, the score is obtained by subtracting the item score from 5. The total SUS score is then calculated by summing the item scores and multiplying by 2.5, yielding a final score that can be categorized into six grades: A (90-100), B (80-89), C (70-79), D (60-69), and F (0-59) according to Bangor, Kortum, and Miller (2009).
Measured: Data were collected at baseline.
System Usability
The research project assessed changes in system usability by System Usability Scale (SUS) .
The System Usability Scale (SUS), originally proposed by Brooke in 1986 (Brooke, 1996). The SUS consists of 10 items, scored using a 5-point Likert scale, with options ranging from strongly agree to strongly disagree. Strongly agree is scored as 5 points, and strongly disagree as 1 point. For positively worded items, the score is calculated by subtracting 1 from the item score, while for negatively worded items, the score is obtained by subtracting the item score from 5. The total SUS score is then calculated by summing the item scores and multiplying by 2.5, yielding a final score that can be categorized into six grades: A (90-100), B (80-89), C (70-79), D (60-69), and F (0-59) according to Bangor, Kortum, and Miller (2009).
Measured: Data were collected at 1 months after the Interventions.
System Usability
The research project assessed changes in system usability by System Usability Scale (SUS) .
The System Usability Scale (SUS), originally proposed by Brooke in 1986 (Brooke, 1996). The SUS consists of 10 items, scored using a 5-point Likert scale, with options ranging from strongly agree to strongly disagree. Strongly agree is scored as 5 points, and strongly disagree as 1 point. For positively worded items, the score is calculated by subtracting 1 from the item score, while for negatively worded items, the score is obtained by subtracting the item score from 5. The total SUS score is then calculated by summing the item scores and multiplying by 2.5, yielding a final score that can be categorized into six grades: A (90-100), B (80-89), C (70-79), D (60-69), and F (0-59) according to Bangor, Kortum, and Miller (2009).
Measured: Data were collected at 3 months after the Interventions.
mHealth App Usability
The research project assessed changes in mHealth App usability by mHealth App Usability Questionnaire (MAUQ) .
This study chose to use the 21-item mHealth App Usability Questionnaire (MAUQ) (Zhou et al., 2009). Strongly agree is scored as 7 points, and strongly disagree as 1 point. The MAUQ has demonstrated good reliability and validity during its development process. In terms of internal consistency, the three subscales-Ease of Use and Satisfaction (MAUQ_E), System Information Arrangement (MAUQ_S), and Usefulness (MAUQ_U)-have Cronbach's α values of 0.895, 0.829, and 0.900, respectively.
Measured: Data were collected at baseline.
mHealth App Usability
The research project assessed changes in mHealth App usability by mHealth App Usability Questionnaire (MAUQ).
This study chose to use the 21-item mHealth App Usability Questionnaire (MAUQ) (Zhou et al., 2009). Strongly agree is scored as 7 points, and strongly disagree as 1 point. The MAUQ has demonstrated good reliability and validity during its development process. In terms of internal consistency, the three subscales-Ease of Use and Satisfaction (MAUQ_E), System Information Arrangement (MAUQ_S), and Usefulness (MAUQ_U)-have Cronbach's α values of 0.895, 0.829, and 0.900, respectively.
Measured: Data were collected at 1 months after the Interventions.
mHealth App Usability
The research project assessed changes in mHealth App usability by mHealth App Usability Questionnaire (MAUQ) from baseline to 3 months after the Interventions.
This study chose to use the 21-item mHealth App Usability Questionnaire (MAUQ) (Zhou et al., 2009). Strongly agree is scored as 7 points, and strongly disagree as 1 point. The MAUQ has demonstrated good reliability and validity during its development process. In terms of internal consistency, the three subscales-Ease of Use and Satisfaction (MAUQ_E), System Information Arrangement (MAUQ_S), and Usefulness (MAUQ_U)-have Cronbach's α values of 0.895, 0.829, and 0.900, respectively.
Measured: Data were collected at 3 months after the Interventions.
Bot Usability
The research project assessed changes in Chatbot usability by Chatbot Usability Scale(BUS).
This study utilizes the Chatbot Usability Scale (BUS-11) developed by Borsci et al. (2023) to assess chatbot usability. The scale uses a 5-point Likert scale, with scores ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 11 to 55, with higher scores indicating greater user satisfaction with the chatbot's usability (Borsci et al., 2023).The Cronbach's alpha value is 0.90, indicating a high level of internal consistency among the items in the scale (Borsci et al., 2023).
Measured: Data were collected at baseline.
Bot Usability
The research project assessed changes in Chatbot usability by Chatbot Usability Scale(BUS).
This study utilizes the Chatbot Usability Scale (BUS-11) developed by Borsci et al. (2023) to assess chatbot usability. The scale uses a 5-point Likert scale, with scores ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 11 to 55, with higher scores indicating greater user satisfaction with the chatbot's usability (Borsci et al., 2023).The Cronbach's alpha value is 0.90, indicating a high level of internal consistency among the items in the scale (Borsci et al., 2023).
Measured: Data were collected at 1 months after the Interventions.
Bot Usability
The research project assessed changes in Chatbot usability by Chatbot Usability Scale(BUS) from baseline to 3 months after the Interventions.
This study utilizes the Chatbot Usability Scale (BUS-11) developed by Borsci et al. (2023) to assess chatbot usability. The scale uses a 5-point Likert scale, with scores ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 11 to 55, with higher scores indicating greater user satisfaction with the chatbot's usability (Borsci et al., 2023).The Cronbach's alpha value is 0.90, indicating a high level of internal consistency among the items in the scale (Borsci et al., 2023).
Measured: Data were collected at 3 months after the Interventions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 202031 Dec 2024

First posted14 Aug 2024
Study start16 Oct 2020
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Mobile HealthStudies of the same condition, open and under way.
More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Participant
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06552494
Sponsor's protocol ID: 109-2629-H-182-001
Status last verified: Mar 2026
First submitted: 8 Aug 2024
Last updated: 23 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

American Cancer Society. Cancer facts & figures.Retrieved from https://www.cancer.org/ 2018.
Aass N, Fossa SD, Dahl AA, Moe TJ. Prevalence of anxiety and depression in cancer patients seen at the Norwegian Radium Hospital. Eur J Cancer. 1997 Sep;33(10):1597-604. doi: 10.1016/s0959-8049(97)00054-3.
PubMed 9389921
Abras, C., Maloney-Krichmar, D., & Preece, J. User-centered design. Bainbridge, W. Encyclopedia of Human-Computer Interaction. Thousand Oaks: Sage Publications. 2004; 37(4), 445-456.
Akkuzu G, Kurt G, Guvenc G, Kok G, Simsek S, Dogrusoy S, Ayhan A. Learning Needs of Gynecologic Cancer Survivors. J Cancer Educ. 2018 Jun;33(3):544-550. doi: 10.1007/s13187-016-1118-y.
PubMed 27743314
Athilingam P, Labrador MA, Remo EF, Mack L, San Juan AB, Elliott AF. Features and usability assessment of a patient-centered mobile application (HeartMapp) for self-management of heart failure. Appl Nurs Res. 2016 Nov;32:156-163. doi: 10.1016/j.apnr.2016.07.001. Epub 2016 Jul 11.
PubMed 27969021
Bandura, A. Guide for constructing self-efficacy scales. Self-efficacy beliefs of adolescents. 2006; 5(1), 307-337.
Bangor, A., Kortum, P., & Miller, J. Determining what individual SUS scores mean: Adding an adjective rating scale. Journal of usability studies.2009; 4(3), 114-123.
Boyce, C., & Neale, P. Conducting in-depth interviews: A guide for designing and conducting in-depth interviews for evaluation input. 2006.
Bricker JB, Mull KE, Kientz JA, Vilardaga R, Mercer LD, Akioka KJ, Heffner JL. Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy. Drug Alcohol Depend. 2014 Oct 1;143:87-94. doi: 10.1016/j.drugalcdep.2014.07.006. Epub 2014 Jul 17.
PubMed 25085225
Broderick, J., Devine, T., Langhans, E., Lemerise, A. J., Lier, S., & Harris, L. Designing health literate mobile apps: Institute of Medicine of the National Academies Washington, DC.2014.
Brooke, J. SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.1996.
Chaudry, B. M., Connelly, K. H., Siek, K. A., & Welch, J. L. Mobile interface design for low-literacy populations. Paper presented at the Proceedings of the 2nd ACM SIGHIT international health informatics symposium.2012.
Faller H, Koch U, Brahler E, Harter M, Keller M, Schulz H, Wegscheider K, Weis J, Boehncke A, Hund B, Reuter K, Richard M, Sehner S, Szalai C, Wittchen HU, Mehnert A. Satisfaction with information and unmet information needs in men and women with cancer. J Cancer Surviv. 2016 Feb;10(1):62-70. doi: 10.1007/s11764-015-0451-1. Epub 2015 May 9.
PubMed 25956402
Fischer OJ, Marguerie M, Brotto LA. Sexual Function, Quality of Life, and Experiences of Women with Ovarian Cancer: A Mixed-Methods Study. Sex Med. 2019 Dec;7(4):530-539. doi: 10.1016/j.esxm.2019.07.005. Epub 2019 Sep 7.
PubMed 31501030
Hevner, A. R. A three cycle view of design science research. Scandinavian journal of information systems. 2007;19(2), 4.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing and Testing an Integrated mHealth Learning Program for Gynecological Cancer
ClinicalTrials.gov ID: NCT06552494
Acronym / sponsor ID: 109-2629-H-182-001
Conditions: Mobile Health
Keywords: gynecological cancer, mobile health, mobile health learning, mHealth application
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: 16 Oct 2020 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 14 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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.

Arm	Type	Receives
The intervention group	Experimental	Other: L-mHealth programThe 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."
The control group	No intervention	–The control group receiving care as usual alone.

Who may qualify

Ages: 20 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Women definitively or suspected to be diagnosed with ovarian cancer, with the cancer staged at Stage 3 or below.
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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
L-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.	Other	The intervention group

Primary outcome

Symptom Distress
Time frame: Data were collected at baseline.
The research project assessed changes in symptom distress by Symptom Distress Scale-Chinese Modified Form (SDS-CMF) . Symptom Distress Scale-Chinese Modified Form (SDS-CMF), revised by Lai (1998), for the symptom assessment of ovarian cancer patients. The scale is adapted from the Symptom Distress Scale (SDS) developed by McCorkle and Young (1978) for lung cancer patients. The scoring method uses a 5-point Likert scale to assess the level of symptom distress as self-reported by cancer patients. A score of 1 indicates no distress at all, 2 indicates mild distress, 3 indicates moderate distress, 4 indicates severe distress, and 5 indicates very severe distress. The total score ranges from 25 to 125, with higher scores indicating more severe symptom distress. The Cronbach's alpha value for cervical cancer patients in our country was 0.87, and the content validity was 0.92 (Chen et al., 2007).
Symptom Distress
Time frame: Data were collected at 1 months after the Interventions.
The research project assessed changes in symptom distress by Symptom Distress Scale-Chinese Modified Form (SDS-CMF) . Symptom Distress Scale-Chinese Modified Form (SDS-CMF), revised by Lai (1998), for the symptom assessment of ovarian cancer patients. The scale is adapted from the Symptom Distress Scale (SDS) developed by McCorkle and Young (1978) for lung cancer patients. The scoring method uses a 5-point Likert scale to assess the level of symptom distress as self-reported by cancer patients. A score of 1 indicates no distress at all, 2 indicates mild distress, 3 indicates moderate distress, 4 indicates severe distress, and 5 indicates very severe distress. The total score ranges from 25 to 125, with higher scores indicating more severe symptom distress.The Cronbach's alpha value for cervical cancer patients in our country was 0.87, and the content validity was 0.92 (Chen et al., 2007).
Symptom Distress
Time frame: Data were collected at 3 months after the Interventions.
The research project assessed changes in symptom distress by Symptom Distress Scale-Chinese Modified Form (SDS-CMF). Symptom Distress Scale-Chinese Modified Form (SDS-CMF), revised by Lai (1998), for the symptom assessment of ovarian cancer patients. The scale is adapted from the Symptom Distress Scale (SDS) developed by McCorkle and Young (1978) for lung cancer patients. The scoring method uses a 5-point Likert scale to assess the level of symptom distress as self-reported by cancer patients. A score of 1 indicates no distress at all, 2 indicates mild distress, 3 indicates moderate distress, 4 indicates severe distress, and 5 indicates very severe distress. The total score ranges from 25 to 125, with higher scores indicating more severe symptom distress. The Cronbach's alpha value for cervical cancer patients in our country was 0.87, and the content validity was 0.92 (Chen et al., 2007).
Communication and Attitudinal Self-Efficacy for cancer
Time frame: Data were collected at baseline.
The research project assessed changes in communication and attitudinal self-efficacy for cancer by Communication and Attitudinal Self-Efficacy scale for cancer (CASE). The "Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE)," originally designed by Wolf et al. (2005) and translated by Yang (2005). The scale comprises three major dimensions: the ability to understand and participate in care, the ability to maintain a positive attitude, and the ability to seek and obtain information, totaling 12 items. The scoring uses a Likert scale, ranging from strongly disagree (1 point) to strongly agree (5 points). The reliability of the scale, as measured by internal consistency, shows a Cronbach's α value ranging from 0.80 to 0.95 across the different dimensions.
Communication and Attitudinal Self-Efficacy for cancer
Time frame: Data were collected at 1 months after the Interventions.
The research project assessed changes in communication and attitudinal self-efficacy for cancer by Communication and Attitudinal Self-Efficacy scale for cancer (CASE) . The "Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE)," originally designed by Wolf et al. (2005) and translated by Yang (2005). The scale comprises three major dimensions: the ability to understand and participate in care, the ability to maintain a positive attitude, and the ability to seek and obtain information, totaling 12 items. The scoring uses a Likert scale, ranging from strongly disagree (1 point) to strongly agree (5 points). The reliability of the scale, as measured by internal consistency, shows a Cronbach's α value ranging from 0.80 to 0.95 across the different dimensions.
Communication and Attitudinal Self-Efficacy for cancer
Time frame: Data were collected at 3 months after the Interventions.
The research project assessed changes in communication and attitudinal self-efficacy for cancer by Communication and Attitudinal Self-Efficacy scale for cancer (CASE). The "Communication and Attitudinal Self-Efficacy Scale for Cancer (CASE)," originally designed by Wolf et al. (2005) and translated by Yang (2005). The scale comprises three major dimensions: the ability to understand and participate in care, the ability to maintain a positive attitude, and the ability to seek and obtain information, totaling 12 items. The scoring uses a Likert scale, ranging from strongly disagree (1 point) to strongly agree (5 points). The reliability of the scale, as measured by internal consistency, shows a Cronbach's α value ranging from 0.80 to 0.95 across the different dimensions.
Needs of Health Information for the patients with Gynecological Cancer
Time frame: Data were collected at baseline.
The research project assessed changes in needs of health information for the patients with gynecological cancer by Informational Needs Questionnaires- Gynecological Cancer. The study utilizes the Chinese version of Informational Needs Questionnaires- Gynecological Cancer, adapted by Lei, Har, \& Abdullah (2011) from the "Toronto Informational Needs Questionnaire-Breast Cancer (TINQ-BC)," and used with the authors' permission (Huang \& Hsieh, 2015). The Chinese version for gynecologic cancer patients was modified from 52 to 50 items, with a scoring system ranging from 1 ('Not needed at all') to 5 ('Greatly needed'). Higher scores indicate a greater need for the information in that item. The Cronbach's alpha coefficients for the subscales range from 0.835 to 0.958 (Chen \& Hsieh, 2017). The Content Validity Index (CVI) values for expert validity range from 0.75 to 0.94 (Hsieh et al., 2018; Huang \& Hsieh, 2015)."
Needs of Health Information for the patients with Gynecological Cancer
Time frame: Data were collected at 1 months after the Interventions.
The research project assessed changes in needs of health information for the patients with gynecological cancer by Informational Needs Questionnaires- Gynecological Cancer . The study utilizes the Chinese version of Informational Needs Questionnaires- Gynecological Cancer, adapted by Lei, Har, \& Abdullah (2011) from the "Toronto Informational Needs Questionnaire-Breast Cancer (TINQ-BC)," and used with the authors' permission (Huang \& Hsieh, 2015). The Chinese version for gynecologic cancer patients was modified from 52 to 50 items, with a scoring system ranging from 1 ('Not needed at all') to 5 ('Greatly needed'). Higher scores indicate a greater need for the information in that item.The Cronbach's alpha coefficients for the subscales range from 0.835 to 0.958 (Chen \& Hsieh, 2017). The Content Validity Index (CVI) values for expert validity range from 0.75 to 0.94 (Hsieh et al., 2018; Huang \& Hsieh, 2015)."
Needs of Health Information for the patients with Gynecological Cancer
Time frame: Data were collected at 3 months after the Interventions.
The research project assessed changes in needs of health information for the patients with gynecological cancer by Informational Needs Questionnaires- Gynecological Cancer. The study utilizes the Chinese version of Informational Needs Questionnaires- Gynecological Cancer, adapted by Lei, Har, \& Abdullah (2011) from the "Toronto Informational Needs Questionnaire-Breast Cancer (TINQ-BC)," and used with the authors' permission (Huang \& Hsieh, 2015). The Chinese version for gynecologic cancer patients was modified from 52 to 50 items, with a scoring system ranging from 1 ('Not needed at all') to 5 ('Greatly needed'). Higher scores indicate a greater need for the information in that item. The Cronbach's alpha coefficients for the subscales range from 0.835 to 0.958 (Chen \& Hsieh, 2017). The Content Validity Index (CVI) values for expert validity range from 0.75 to 0.94 (Hsieh et al., 2018; Huang \& Hsieh, 2015)."
Chatbot Usability
Time frame: Data were collected at baseline.
The research project assessed changes in chatbot usability by Chatbot Usability Questionnaire (CUQ). The Chatbot Usability Questionnaire (CUQ) was developed by Holmes et al. (2019) based on principles of user experience with chatbots. It is similar in design to the System Usability Scale (SUS) by Brooke (1996) but was specifically developed for assessing chatbot usability. The questionnaire consists of 16 items, with 8 related to positive aspects of chatbot usability and 8 related to negative aspects. It uses a 5-point Likert scale for users to rate the chatbot's usability, where 1 indicates strong disagreement, 2 disagreement, 3 neutrality, 4 agreement, and 5 strong agreement. The scores are standardized on a scale of 100 points.The Chatbot Usability Questionnaire (CUQ) demonstrates good internal consistency (r > 0.7) (Holmes et al., 2023).
Chatbot Usability
Time frame: Data were collected at 1 months after the Interventions.
The research project assessed changes in chatbot usability by Chatbot Usability Questionnaire (CUQ) . The Chatbot Usability Questionnaire (CUQ) was developed by Holmes et al. (2019) based on principles of user experience with chatbots. It is similar in design to the System Usability Scale (SUS) by Brooke (1996) but was specifically developed for assessing chatbot usability. The questionnaire consists of 16 items, with 8 related to positive aspects of chatbot usability and 8 related to negative aspects. It uses a 5-point Likert scale for users to rate the chatbot's usability, where 1 indicates strong disagreement, 2 disagreement, 3 neutrality, 4 agreement, and 5 strong agreement. The scores are standardized on a scale of 100 points. The Chatbot Usability Questionnaire (CUQ) demonstrates good internal consistency (r > 0.7) (Holmes et al., 2023).
Chatbot Usability
Time frame: Data were collected at 3 months after the Interventions.
The research project assessed changes in chatbot usability by Chatbot Usability Questionnaire (CUQ) from baseline to 3 months after the Interventions. The Chatbot Usability Questionnaire (CUQ) was developed by Holmes et al. (2019) based on principles of user experience with chatbots. It is similar in design to the System Usability Scale (SUS) by Brooke (1996) but was specifically developed for assessing chatbot usability. The questionnaire consists of 16 items, with 8 related to positive aspects of chatbot usability and 8 related to negative aspects. It uses a 5-point Likert scale for users to rate the chatbot's usability, where 1 indicates strong disagreement, 2 disagreement, 3 neutrality, 4 agreement, and 5 strong agreement. The scores are standardized on a scale of 100 points.The Chatbot Usability Questionnaire (CUQ) demonstrates good internal consistency (r > 0.7) (Holmes et al., 2023).
System Usability
Time frame: Data were collected at baseline.
The research project assessed changes in system usability by System Usability Scale (SUS) . The System Usability Scale (SUS), originally proposed by Brooke in 1986 (Brooke, 1996). The SUS consists of 10 items, scored using a 5-point Likert scale, with options ranging from strongly agree to strongly disagree. Strongly agree is scored as 5 points, and strongly disagree as 1 point. For positively worded items, the score is calculated by subtracting 1 from the item score, while for negatively worded items, the score is obtained by subtracting the item score from 5. The total SUS score is then calculated by summing the item scores and multiplying by 2.5, yielding a final score that can be categorized into six grades: A (90-100), B (80-89), C (70-79), D (60-69), and F (0-59) according to Bangor, Kortum, and Miller (2009).
System Usability
Time frame: Data were collected at 1 months after the Interventions.
The research project assessed changes in system usability by System Usability Scale (SUS) . The System Usability Scale (SUS), originally proposed by Brooke in 1986 (Brooke, 1996). The SUS consists of 10 items, scored using a 5-point Likert scale, with options ranging from strongly agree to strongly disagree. Strongly agree is scored as 5 points, and strongly disagree as 1 point. For positively worded items, the score is calculated by subtracting 1 from the item score, while for negatively worded items, the score is obtained by subtracting the item score from 5. The total SUS score is then calculated by summing the item scores and multiplying by 2.5, yielding a final score that can be categorized into six grades: A (90-100), B (80-89), C (70-79), D (60-69), and F (0-59) according to Bangor, Kortum, and Miller (2009).
System Usability
Time frame: Data were collected at 3 months after the Interventions.
The research project assessed changes in system usability by System Usability Scale (SUS) . The System Usability Scale (SUS), originally proposed by Brooke in 1986 (Brooke, 1996). The SUS consists of 10 items, scored using a 5-point Likert scale, with options ranging from strongly agree to strongly disagree. Strongly agree is scored as 5 points, and strongly disagree as 1 point. For positively worded items, the score is calculated by subtracting 1 from the item score, while for negatively worded items, the score is obtained by subtracting the item score from 5. The total SUS score is then calculated by summing the item scores and multiplying by 2.5, yielding a final score that can be categorized into six grades: A (90-100), B (80-89), C (70-79), D (60-69), and F (0-59) according to Bangor, Kortum, and Miller (2009).
mHealth App Usability
Time frame: Data were collected at baseline.
The research project assessed changes in mHealth App usability by mHealth App Usability Questionnaire (MAUQ) . This study chose to use the 21-item mHealth App Usability Questionnaire (MAUQ) (Zhou et al., 2009). Strongly agree is scored as 7 points, and strongly disagree as 1 point. The MAUQ has demonstrated good reliability and validity during its development process. In terms of internal consistency, the three subscales-Ease of Use and Satisfaction (MAUQ_E), System Information Arrangement (MAUQ_S), and Usefulness (MAUQ_U)-have Cronbach's α values of 0.895, 0.829, and 0.900, respectively.
mHealth App Usability
Time frame: Data were collected at 1 months after the Interventions.
The research project assessed changes in mHealth App usability by mHealth App Usability Questionnaire (MAUQ). This study chose to use the 21-item mHealth App Usability Questionnaire (MAUQ) (Zhou et al., 2009). Strongly agree is scored as 7 points, and strongly disagree as 1 point. The MAUQ has demonstrated good reliability and validity during its development process. In terms of internal consistency, the three subscales-Ease of Use and Satisfaction (MAUQ_E), System Information Arrangement (MAUQ_S), and Usefulness (MAUQ_U)-have Cronbach's α values of 0.895, 0.829, and 0.900, respectively.
mHealth App Usability
Time frame: Data were collected at 3 months after the Interventions.
The research project assessed changes in mHealth App usability by mHealth App Usability Questionnaire (MAUQ) from baseline to 3 months after the Interventions. This study chose to use the 21-item mHealth App Usability Questionnaire (MAUQ) (Zhou et al., 2009). Strongly agree is scored as 7 points, and strongly disagree as 1 point. The MAUQ has demonstrated good reliability and validity during its development process. In terms of internal consistency, the three subscales-Ease of Use and Satisfaction (MAUQ_E), System Information Arrangement (MAUQ_S), and Usefulness (MAUQ_U)-have Cronbach's α values of 0.895, 0.829, and 0.900, respectively.
Bot Usability
Time frame: Data were collected at baseline.
The research project assessed changes in Chatbot usability by Chatbot Usability Scale(BUS). This study utilizes the Chatbot Usability Scale (BUS-11) developed by Borsci et al. (2023) to assess chatbot usability. The scale uses a 5-point Likert scale, with scores ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 11 to 55, with higher scores indicating greater user satisfaction with the chatbot's usability (Borsci et al., 2023).The Cronbach's alpha value is 0.90, indicating a high level of internal consistency among the items in the scale (Borsci et al., 2023).
Bot Usability
Time frame: Data were collected at 1 months after the Interventions.
The research project assessed changes in Chatbot usability by Chatbot Usability Scale(BUS). This study utilizes the Chatbot Usability Scale (BUS-11) developed by Borsci et al. (2023) to assess chatbot usability. The scale uses a 5-point Likert scale, with scores ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 11 to 55, with higher scores indicating greater user satisfaction with the chatbot's usability (Borsci et al., 2023).The Cronbach's alpha value is 0.90, indicating a high level of internal consistency among the items in the scale (Borsci et al., 2023).
Bot Usability
Time frame: Data were collected at 3 months after the Interventions.
The research project assessed changes in Chatbot usability by Chatbot Usability Scale(BUS) from baseline to 3 months after the Interventions. This study utilizes the Chatbot Usability Scale (BUS-11) developed by Borsci et al. (2023) to assess chatbot usability. The scale uses a 5-point Likert scale, with scores ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 11 to 55, with higher scores indicating greater user satisfaction with the chatbot's usability (Borsci et al., 2023).The Cronbach's alpha value is 0.90, indicating a high level of internal consistency among the items in the scale (Borsci et al., 2023).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Results publicationAmerican Cancer Society. Cancer facts & figures.Retrieved from https://www.cancer.org/ 2018.
Results publication: PubMed 9389921Aass N, Fossa SD, Dahl AA, Moe TJ. Prevalence of anxiety and depression in cancer patients seen at the Norwegian Radium Hospital. Eur J Cancer. 1997 Sep;33(10):1597-604. doi: 10.1016/s0959-8049(97)00054-3.
Results publicationAbras, C., Maloney-Krichmar, D., & Preece, J. User-centered design. Bainbridge, W. Encyclopedia of Human-Computer Interaction. Thousand Oaks: Sage Publications. 2004; 37(4), 445-456.
Results publication: PubMed 27743314Akkuzu G, Kurt G, Guvenc G, Kok G, Simsek S, Dogrusoy S, Ayhan A. Learning Needs of Gynecologic Cancer Survivors. J Cancer Educ. 2018 Jun;33(3):544-550. doi: 10.1007/s13187-016-1118-y.
Results publication: PubMed 27969021Athilingam P, Labrador MA, Remo EF, Mack L, San Juan AB, Elliott AF. Features and usability assessment of a patient-centered mobile application (HeartMapp) for self-management of heart failure. Appl Nurs Res. 2016 Nov;32:156-163. doi: 10.1016/j.apnr.2016.07.001. Epub 2016 Jul 11.
Results publicationBandura, A. Guide for constructing self-efficacy scales. Self-efficacy beliefs of adolescents. 2006; 5(1), 307-337.
Results publicationBangor, A., Kortum, P., & Miller, J. Determining what individual SUS scores mean: Adding an adjective rating scale. Journal of usability studies.2009; 4(3), 114-123.
Results publicationBoyce, C., & Neale, P. Conducting in-depth interviews: A guide for designing and conducting in-depth interviews for evaluation input. 2006.
Results publication: PubMed 25085225Bricker JB, Mull KE, Kientz JA, Vilardaga R, Mercer LD, Akioka KJ, Heffner JL. Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy. Drug Alcohol Depend. 2014 Oct 1;143:87-94. doi: 10.1016/j.drugalcdep.2014.07.006. Epub 2014 Jul 17.
Results publicationBroderick, J., Devine, T., Langhans, E., Lemerise, A. J., Lier, S., & Harris, L. Designing health literate mobile apps: Institute of Medicine of the National Academies Washington, DC.2014.
Results publicationBrooke, J. SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.1996.
Results publicationChaudry, B. M., Connelly, K. H., Siek, K. A., & Welch, J. L. Mobile interface design for low-literacy populations. Paper presented at the Proceedings of the 2nd ACM SIGHIT international health informatics symposium.2012.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jian Tao LEE, Professor principal investigator

Chang Gung University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing L-mHealth program in people with Mobile Health, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Distress (time frame: Data were collected at baseline.). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06552494, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.