Developing and Testing an Integrated mHealth Learning Program for Gynecological Cancer
NCT Number: NCT06552494
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mobile Health
Interventions: OTHER: L-mHealth program
Sponsor: Chang Gung Memorial Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2020-10-16
Completion Date: 2024-12-31
Locations: Cheng Gung Memorial Hospital, Taoyuan, Guishan Dist., 333, Taiwan

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.

Primary Outcome Measures: 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)., 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)., 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)., 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., 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., 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., 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).", 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).", 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).", 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)., 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)., 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)., 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)., 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)., 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)., 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., 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., 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., 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)., 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)., 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)., Data were collected at 3 months after the Interventions.