Developing and Testing an Integrated mHealth Learning Program for Gynecological Cancer

NCT06552494 | Completed

• 1 other identifier: 109-2629-H-182-001
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Mobile Health

Keywords

gynecological cancer; mobile health; mobile health learning; mHealth application

Outcome Measures

Primary Outcomes (21)

• 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.

Study Arms (2)

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."

Other: L-mHealth program

The control group

NO INTERVENTION

The control group receiving care as usual alone.

Interventions

L-mHealth program OTHER

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.

The intervention group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: This project aims to develop an integrated mHealth learning program (L-mHealth program) for gynecological cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• to 70 years old. 4.Possesses and is able to use an internet-enabled mobile device (such as a smartphone or tablet).
• Able to clearly communicate and read/write in Mandarin or Taiwanese. 6.Agrees to participate in the study and signs the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Cheng Gung Memorial Hospital

Taoyuan District, Guishan Dist., 333, Taiwan

Location

Related Publications (34)

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Study Officials

• Jian Tao LEE, Professor

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 14, 2024
• Study Start: October 16, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)