Breast NeoplasmsNCT05072197
Mobile Application Support for Women With Breast Cancer Undergoing Chemotherapy
A study testing Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapy in people with Breast Neoplasms, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
Mobile phones have become an essential tool for everyday life. The convenience and easy accessibility of the data and information received through mobile phones have made mobile applications as the latest trend to provide education for patients in medical centers. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 May 2021to 31 Dec 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 20 years of age.
- diagnosed with breast cancer for the first time.
- treated with chemotherapy at the study sites.
- able to access the internet with a mobile phone.
- Fluent in spoken and written Chinese .
Who cannot join
- patients with cognitive dysfunction.
- diagnosed mental health problems.
- having with other cancers.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cheng Hsin General Hospital
Taipei
Ya-Hui Liang, BS, +886952823710, liang6823@yahoo.com.tw
About this study
Official title: The Effectiveness of a Mobile Application as a Support Tool for the Treatment of Women With Breast Cancer Undergoing Chemotherapy: A Randomized Controlled Trial
Mobile phones have become an essential tool for everyday life. The convenience and easy accessibility of the data and information received through mobile phones have made mobile applications as the latest trend to provide education for patients in medical centers. In Taiwan, breast cancer incidence has been the highest among all cancers and the fourth leading cause of cancer deaths in women. Women with breast cancer who are undergoing chemotherapy suffer from a number of symptoms throughout the chemotherapy treatment that detrimentally affects their quality of life. Thus, providing social support and nursing care aids for these vulnerable women is imperative to help them face their breast cancer challenges. This study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers. This study will use a mixed-methods design to develop a Mobile device application based on breast cancer literature and the clinical experiences of breast cancer patients to fulfill the needs women may experience during the chemotherapy treatment. Women with breast cancer will be invited to help refine the Mobile device application's content based on their experiences and feedback about the mobile application. Upon completing the mobile application development, women with breast cancer patients will be recruited to participate in a randomized controlled trial to examine the effectiveness of the mobile application. The results of this study will provide a foundation to deliver a remote, personalized, and continuous health care model to improve the self-efficacy, social support, and quality of life of women with breast cancer, and ultimately enhancing the overall quality of care and patient satisfaction with the medical care participants receive.
Read the detailed description
This application has four modules: 1) a Learning forum; 2) a Ask-the-Expert forum; 3) a Website link forum; 4) a Encouragement forum. The intervention group will receive routine care plus access to the "B with you" program during their six cycles of chemotherapy. Self-efficacy, social support, and quality of life will be measured at baseline, then the 3rd and 6th cycles of chemotherapy.
- Conditions
- Breast Neoplasms
- Being tested
- Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapy
- Keywords
- breast cancer, mobile applications, self-efficacy, social support, quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapyDevice
This study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers.
| Study group | Role | What they receive |
|---|---|---|
| Mobile device application group | Experimental | routine care and mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment Receives: Device: Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapy |
| control group | No intervention | routine care for breast cancer women during their chemotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline score of the Symptom-Management Self-Efficacy Scale-Breast Cancer, SMSES-BC at the third chemotherapy (T1) and the sixth chemotherapy (T2).
The SMSES-BC scale is a 27-question tool used to assess the self-confidence level of the symptom self-care process of women with breast cancer when participants have side effects and other related symptoms during chemotherapy. There are three parts: seeking problem-solving and related resources (7 questions), dealing with symptoms related to chemotherapy (15 questions), and dealing with emotions and interpersonal troubles (5 questions). The Likert scale method is used to score. 0 points mean very unconfident, 10 points mean very confident, and the score ranges from 0 to 270 points. The higher score obtained according to the scale, the more confident of symptom management during chemotherapy among the women with breast cancer
Measured: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
Change from the baseline score of the Social Support Scale at the third chemotherapy (T1) and the sixth chemotherapy (T2).
The Social Support Scale is concerned with ways in which others affect persons' responses to stressful events. In the Social Support Scale, there is16 questions. The social support scale is divided into spouses, relatives and friends, and medical staff. The four social support functions it covers include: emotional support (questions 1-4), information support (questions 5-8), substantive support (questions 9-12), and evaluative support (13-16 questions); based on the subjective perception of the patient, the degree of support from spouses, relatives and friends, and medical staff is measured. The score is based on the Likert five-point method. The total score ranges from 16 to 80 points. The higher the score, the higher the degree of social support.
Measured: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
Change from the baseline score of the Functional Assessment of Cancer Therapy - Breast, FACT-B at the third chemotherapy (T1) and the sixth chemotherapy (T2).
The quality of life variables in this study will use the Functional Assessment of Cancer Therapy-Breast (FACT-B), a measurement tool for breast cancer patients' health-related quality of life. It can be used to understand the quality of life of breast cancer patients in the past week. There are 37 questions in total, divided into five aspects, including: physical health (7 questions), social/family health (7 questions), emotional health (6 questions), functional health (7 questions), and additional concerns ( 10 questions). The Likert five-point method is used for scoring (0-not at all, 1-a little, 2-some, 3-equivalent, and 4-very). The score range is 0-148 points, based on each score of the respondent's self-evaluation. The higher the total score, the better the quality of life of breast cancer patients.
Measured: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
Secondary outcomes (1)
The User Version of the Mobile Application Rating Scale, uMARS
The Mobile Application Rating Scale-User version is a simple and reliable quality assessment tool for health-related mobile applications. There are a total of 26 questions on the scale, using a 5-point scoring method (1-Insufficient, 2-Poor, 3-Acceptable, 4-Good, 5-Excellent), in order to adapt to the different situations of each mobile application. There is also an option of "not applicable" for one question. Divided into four objective quality aspects-participation (5 questions), functionality (4 questions), aesthetics (3 questions), information quality (4 questions), a subjective quality facet (4 questions) and a The impact of healthy behavior (6 questions), there are a total of 6 dimensions. The score is presented by the average score of each quality dimension and the total scale, the highest is 5 points, and the lowest is 1 point. The higher the average score, the better the quality.
Measured: Data will be collected at the sixth chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start16 May 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Hui Liang, BS, Principal investigator, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072197
- Sponsor's protocol ID
- (818)109A-57
- Status last verified
- Mar 2023
- First submitted
- 13 Sep 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akechi T, Yamaguchi T, Uchida M, Imai F, Momino K, Katsuki F, Sakurai N, Miyaji T, Horikoshi M, Furukawa TA, Iwata H, Uchitomi Y. Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial. BMJ Open. 2018 Nov 8;8(11):e024794. doi: 10.1136/bmjopen-2018-024794.
PubMed 30413519Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials. Lancet Oncol. 2018 Jan;19(1):27-39. doi: 10.1016/S1470-2045(17)30777-5. Epub 2017 Dec 11.
PubMed 29242041Binotto M, Reinert T, Werutsky G, Zaffaroni F, Schwartsmann G. Health-related quality of life before and during chemotherapy in patients with early-stage breast cancer. Ecancermedicalscience. 2020 Jan 27;14:1007. doi: 10.3332/ecancer.2020.1007. eCollection 2020.
PubMed 32104209Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
PubMed 9060536Handa S, Okuyama H, Yamamoto H, Nakamura S, Kato Y. Effectiveness of a Smartphone Application as a Support Tool for Patients Undergoing Breast Cancer Chemotherapy: A Randomized Controlled Trial. Clin Breast Cancer. 2020 Jun;20(3):201-208. doi: 10.1016/j.clbc.2020.01.004. Epub 2020 Feb 26.
PubMed 32201165Hou IC, Lin HY, Shen SH, Chang KJ, Tai HC, Tsai AJ, Dykes PC. Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 4;8(3):e17084. doi: 10.2196/17084.
PubMed 32130181Ng R, Lee CF, Wong NS, Luo N, Yap YS, Lo SK, Chia WK, Yee A, Krishna L, Goh C, Cheung YB. Measurement properties of the English and Chinese versions of the Functional Assessment of Cancer Therapy-Breast (FACT-B) in Asian breast cancer patients. Breast Cancer Res Treat. 2012 Jan;131(2):619-25. doi: 10.1007/s10549-011-1764-z. Epub 2011 Sep 16.
PubMed 21922244Sakai H, Umeda M, Okuyama H, Nakamura S. Differences in perception of breast cancer treatment between patients, physicians, and nurses and unmet information needs in Japan. Support Care Cancer. 2020 May;28(5):2331-2338. doi: 10.1007/s00520-019-05029-z. Epub 2019 Sep 3.
PubMed 31482403Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
PubMed 27287964Yanez B, Oswald LB, Baik SH, Buitrago D, Iacobelli F, Perez-Tamayo A, Guitelman J, Penedo FJ, Buscemi J. Brief culturally informed smartphone interventions decrease breast cancer symptom burden among Latina breast cancer survivors. Psychooncology. 2020 Jan;29(1):195-203. doi: 10.1002/pon.5281. Epub 2019 Nov 15.
PubMed 31693265Wan C, Zhang D, Yang Z, Tu X, Tang W, Feng C, Wang H, Tang X. Validation of the simplified Chinese version of the FACT-B for measuring quality of life for patients with breast cancer. Breast Cancer Res Treat. 2007 Dec;106(3):413-8. doi: 10.1007/s10549-007-9511-1. Epub 2007 Mar 22.
PubMed 17377841
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Mobile Application as a Support Tool for the Treatment of Women With Breast Cancer Undergoing Chemotherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05072197
- Acronym / sponsor ID
- (818)109A-57
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, mobile applications, self-efficacy, social support, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 16 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Oct 2021 (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.
Mobile phones have become an essential tool for everyday life. The convenience and easy accessibility of the data and information received through mobile phones have made mobile applications as the latest trend to provide education for patients in medical centers. In Taiwan, breast cancer incidence has been the highest among all cancers and the fourth leading cause of cancer deaths in women. Women with breast cancer who are undergoing chemotherapy suffer from a number of symptoms throughout the chemotherapy treatment that detrimentally affects their quality of life. Thus, providing social support and nursing care aids for these vulnerable women is imperative to help them face their breast cancer challenges. This study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers. This study will use a mixed-methods design to develop a Mobile device application based on breast cancer literature and the clinical experiences of breast cancer patients to fulfill the needs women may experience during the chemotherapy treatment. Women with breast cancer will be invited to help refine the Mobile device application's content based on their experiences and feedback about the mobile application. Upon completing the mobile application development, women with breast cancer patients will be recruited to participate in a randomized controlled trial to examine the effectiveness of the mobile application. The results of this study will provide a foundation to deliver a remote, personalized, and continuous health care model to improve the self-efficacy, social support, and quality of life of women with breast cancer, and ultimately enhancing the overall quality of care and patient satisfaction with the medical care participants receive.
Detailed description
This application has four modules: 1) a Learning forum; 2) a Ask-the-Expert forum; 3) a Website link forum; 4) a Encouragement forum. The intervention group will receive routine care plus access to the "B with you" program during their six cycles of chemotherapy. Self-efficacy, social support, and quality of life will be measured at baseline, then the 3rd and 6th cycles of chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile device application group | Experimental | Device: Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapyroutine care and mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment |
| control group | No intervention | –routine care for breast cancer women during their chemotherapy treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 20 years of age.
- diagnosed with breast cancer for the first time.
- treated with chemotherapy at the study sites.
- able to access the internet with a mobile phone.
- Fluent in spoken and written Chinese .
Key exclusion criteria (3 listed)
- patients with cognitive dysfunction.
- diagnosed mental health problems.
- having with other cancers.
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 |
|---|---|---|
| Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapyThis study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers. | Device | Mobile device application group |
Primary outcome
Change from the baseline score of the Symptom-Management Self-Efficacy Scale-Breast Cancer, SMSES-BC at the third chemotherapy (T1) and the sixth chemotherapy (T2).
Time frame: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
The SMSES-BC scale is a 27-question tool used to assess the self-confidence level of the symptom self-care process of women with breast cancer when participants have side effects and other related symptoms during chemotherapy. There are three parts: seeking problem-solving and related resources (7 questions), dealing with symptoms related to chemotherapy (15 questions), and dealing with emotions and interpersonal troubles (5 questions). The Likert scale method is used to score. 0 points mean very unconfident, 10 points mean very confident, and the score ranges from 0 to 270 points. The higher score obtained according to the scale, the more confident of symptom management during chemotherapy among the women with breast cancer
Change from the baseline score of the Social Support Scale at the third chemotherapy (T1) and the sixth chemotherapy (T2).
Time frame: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
The Social Support Scale is concerned with ways in which others affect persons' responses to stressful events. In the Social Support Scale, there is16 questions. The social support scale is divided into spouses, relatives and friends, and medical staff. The four social support functions it covers include: emotional support (questions 1-4), information support (questions 5-8), substantive support (questions 9-12), and evaluative support (13-16 questions); based on the subjective perception of the patient, the degree of support from spouses, relatives and friends, and medical staff is measured. The score is based on the Likert five-point method. The total score ranges from 16 to 80 points. The higher the score, the higher the degree of social support.
Change from the baseline score of the Functional Assessment of Cancer Therapy - Breast, FACT-B at the third chemotherapy (T1) and the sixth chemotherapy (T2).
Time frame: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).
The quality of life variables in this study will use the Functional Assessment of Cancer Therapy-Breast (FACT-B), a measurement tool for breast cancer patients' health-related quality of life. It can be used to understand the quality of life of breast cancer patients in the past week. There are 37 questions in total, divided into five aspects, including: physical health (7 questions), social/family health (7 questions), emotional health (6 questions), functional health (7 questions), and additional concerns ( 10 questions). The Likert five-point method is used for scoring (0-not at all, 1-a little, 2-some, 3-equivalent, and 4-very). The score range is 0-148 points, based on each score of the respondent's self-evaluation. The higher the total score, the better the quality of life of breast cancer patients.
1 secondary outcome
The User Version of the Mobile Application Rating Scale, uMARS
Time frame: Data will be collected at the sixth chemotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 30413519Akechi T, Yamaguchi T, Uchida M, Imai F, Momino K, Katsuki F, Sakurai N, Miyaji T, Horikoshi M, Furukawa TA, Iwata H, Uchitomi Y. Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial. BMJ Open. 2018 Nov 8;8(11):e024794. doi: 10.1136/bmjopen-2018-024794.
- Background: PubMed 29242041Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials. Lancet Oncol. 2018 Jan;19(1):27-39. doi: 10.1016/S1470-2045(17)30777-5. Epub 2017 Dec 11.
- Background: PubMed 32104209Binotto M, Reinert T, Werutsky G, Zaffaroni F, Schwartsmann G. Health-related quality of life before and during chemotherapy in patients with early-stage breast cancer. Ecancermedicalscience. 2020 Jan 27;14:1007. doi: 10.3332/ecancer.2020.1007. eCollection 2020.
- Background: PubMed 9060536Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
- Background: PubMed 32201165Handa S, Okuyama H, Yamamoto H, Nakamura S, Kato Y. Effectiveness of a Smartphone Application as a Support Tool for Patients Undergoing Breast Cancer Chemotherapy: A Randomized Controlled Trial. Clin Breast Cancer. 2020 Jun;20(3):201-208. doi: 10.1016/j.clbc.2020.01.004. Epub 2020 Feb 26.
- Background: PubMed 32130181Hou IC, Lin HY, Shen SH, Chang KJ, Tai HC, Tsai AJ, Dykes PC. Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 4;8(3):e17084. doi: 10.2196/17084.
- Background: PubMed 21922244Ng R, Lee CF, Wong NS, Luo N, Yap YS, Lo SK, Chia WK, Yee A, Krishna L, Goh C, Cheung YB. Measurement properties of the English and Chinese versions of the Functional Assessment of Cancer Therapy-Breast (FACT-B) in Asian breast cancer patients. Breast Cancer Res Treat. 2012 Jan;131(2):619-25. doi: 10.1007/s10549-011-1764-z. Epub 2011 Sep 16.
- Background: PubMed 31482403Sakai H, Umeda M, Okuyama H, Nakamura S. Differences in perception of breast cancer treatment between patients, physicians, and nurses and unmet information needs in Japan. Support Care Cancer. 2020 May;28(5):2331-2338. doi: 10.1007/s00520-019-05029-z. Epub 2019 Sep 3.
- Background: PubMed 27287964Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
- Background: PubMed 31693265Yanez B, Oswald LB, Baik SH, Buitrago D, Iacobelli F, Perez-Tamayo A, Guitelman J, Penedo FJ, Buscemi J. Brief culturally informed smartphone interventions decrease breast cancer symptom burden among Latina breast cancer survivors. Psychooncology. 2020 Jan;29(1):195-203. doi: 10.1002/pon.5281. Epub 2019 Nov 15.
- Background: PubMed 17377841Wan C, Zhang D, Yang Z, Tu X, Tang W, Feng C, Wang H, Tang X. Validation of the simplified Chinese version of the FACT-B for measuring quality of life for patients with breast cancer. Breast Cancer Res Treat. 2007 Dec;106(3):413-8. doi: 10.1007/s10549-007-9511-1. Epub 2007 Mar 22.
- 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.
Ya-Hui Liang, BS principal investigator
Cheng-Hsin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapy in people with Breast Neoplasms, run by Cheng-Hsin General 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Hui Liang, BS (+886952823710, liang6823@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline score of the Symptom-Management Self-Efficacy Scale-Breast Cancer, SMSES-BC at the third chemotherapy (T1) and the sixth chemotherapy (T2). (time frame: Data will be collected before chemotherapy (baseline), the third chemotherapy (T1), and the sixth chemotherapy (T2).). The study lists 3 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 NCT05072197, which also lists 11 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 16 Mar 2023.