Breast CancerNCT05925257
Digital Health Intervention to Improve Health Care and Outcomes for Breast Cancer Patients
A study testing ePRO application and proactive clinical care with nurses. in people with Breast Cancer, run by Coordinación de Investigación en Salud, Mexico at 3 sites in Mexico.
Trial summary
Background: Nearly 30,000 Mexican women develop breast cancer annually. These patients frequently present multiple unmet supportive care needs. In high-income settings, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and… Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ePRO application and proactive clinical care with nurses.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 3 sitesMexico
- Study dates
- 5 Mar 2024to 10 Oct 2025
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Age between 20 and 75 years
- Breast cancer stages I, II, or III
- Neoadjuvant or adjuvant treatment with chemotherapy that started within two to six weeks before enrollment
- Access to the internet on mobile phone, computer or tablet
- Written informed consent
Who cannot join
- Illiterate
- Stage IV breast cancer
- Cognitive dysfunction
- Blindness or low vision not corrected with glasses
- Severe depression (≥12 points on the Hospital Anxiety and Depression Scale)
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
UMAE Hospital de Gineco-Obstetricia No.3 "Dr. Víctor Manuel Espinoza de los Reyes Sánchez" CMN La Raza.
Mexico City, Mexico City, 02990
Hospital de Oncología del Centro Médico Nacional Siglo XXI
Mexico City, Mexico City, 06720
UMAE Hospital de Especialidades CMN "Gral. de Div. Manuel Ávila Camacho"
Puebla City, 72089
About this study
Official title: Design and Evaluation of the Effectiveness of a Digital Health Intervention to Improve Health Care and Outcomes for Cancer Patients
Background: Nearly 30,000 Mexican women develop breast cancer annually. These patients frequently present multiple unmet supportive care needs. In high-income settings, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducing unmet needs. No such ePRO interventions have been implemented in Mexico. The objectives of this study are (I) to design a two-component intervention for monitoring ePROs among breast cancer patients using a responsive digital application and proactive follow-up by nurses, (II) to perform intervention pilot testing of the study materials, and (III) to conduct the clinical trial to assess usability and effectiveness of the intervention.
Methods. The investigators designed a two-component intervention for women receiving breast cancer treatment: a responsive web application for monitoring ePROs and clinical algorithms guiding proactive follow-up by nurses. The investigators will conduct a pilot test of the intervention with 50 breast cancer patients for six weeks to assess the feasibility and inform intervention adaptations. After that, the investigators will conduct a parallel arm randomized controlled trial assigning 205 patients each to intervention and control in one of Mexico's largest public oncology hospitals. The intervention will be provided for six months, with additional three months of post-intervention observation. The control group will receive usual healthcare and a list of information sources on relevant breast cancer topics. Women diagnosed with stages I, II, or III breast cancer who initiate chemo and/or radiotherapy will be invited to participate. The study outcomes will include supportive care needs, quality of life, use of emergency services and unscheduled hospitalizations, the usability of the ePRO App, and adherence to the intervention. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6, and 9 months.
Read the detailed description
An unblinded, parallel-arm, randomized, controlled clinical trial will be conducted. This phase 2 clinical trial focuses on exploring the effect of the intervention on the study variables.The intervention group will be given access to the ePRO application and proactive clinical care, including study nurses responding to ePROs and weekly health information videos for six months. Participants of the control group will be provided with a list of electronic links to videos on breast cancer-relevant topics on the websites of recognised cancer associations and health institutions. All participants will continue to receive the usual health care provided by the hospital. Study intervention wil last 6 months with additional passive folow-up till 9 months to allow post-intervention monitoring.
The participants will be randomly allocated to the intervention or control groups. The minimization technique with MS-DOS Minim program will be used for randomization. It will be conducted by a research assistant who will use a pre-prepared list of random numbers to randomize the first six participants. Starting with the seventh participant, randomization will be carried out using MS-DOS Minim program. The minimization technique is recommended as a standard to ensure that clinical trial groups are similar in terms of participant characteristics, such as age, schooling, breast cancer stage and treatment modality.
Intervention implementation: The lead researcher will weekly obtain the list of breast cancer patients who have started or will start neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy within two weeks in the oncology hospital. The previously trained nurses will use this list to invite all eligible breast cancer patients to participate in the study. Initially, patients will be invited by telephone calls to attend the hospital or the research unit (located at the same medical center as the oncology hospital) to receive the study-related information and to confirm eligibility. Those who meet the inclusion criteria will be provided with the option to participate and invited to provide informed consent prior to participation. Participants will be provided with a username, password, and access to the intervention or control interface of the responsive ePRO App, and training on its use. All participants will be asked to answer the baseline record of sociodemographic and clinical characteristics and questionnaires to assess study outcomes. Intervention arm participants will be asked to complete the weekly register and will receive weekly WhatsApp reminders. Study nurses will contact patients without two weekly records to encourage adherence to the intervention. Study nurses will be supported by the study oncologist/ oncology resident to ensure adherence to the intervention activities. Additionally, the nurses will be in regular contact with the study team and will record their activities in the corresponding interface of the responsive ePRO App.
- Conditions
- Breast Cancer
- Being tested
- ePRO application and proactive clinical care with nurses.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePRO application and proactive clinical care with nurses.Other
The investigators defined ePRO intervention as a weekly register of breast cancer patients' symptoms and supportive care needs using the study ePRO App combined with proactive follow-up by nurses guided by predefined clinical algorithms and a weekly cellphone message providing an educational video from a recognised cancer association or health institution. The intervention will be provided for six months with additional three months of post-intervention observation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will be given access to the ePRO application and proactive clinical care, including study nurses responding to ePROs and weekly health information videos for six months. Receives: Other: ePRO application and proactive clinical care with nurses. |
| Control group | No intervention | Participants of the control group will be provided with a list of electronic links to videos on breast cancer-relevant topics on the websites of recognised cancer associations and health institutions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health systems and information supportive care needs
Change from baseline in health systems and information supportive care needs at 1, 3, 6 and 9 months after the intervention commencement, which will be measured with the Supportive Care Needs Survey Short Form-34 (SCNS SF-34) questionnaire validated in Mexico.
Measured: At 1, 3, 6 and 9 months after intervention commencement
Secondary outcomes (2)
Global quality of life
Change from baseline in Global quality of life at 1, 3, 6 and 9 months after the intervention commencement, which will be measured with the EORTC (European Organization for Research and Treatment of Cancer) QLQ-C30 questionnaire validated in Mexico
Measured: At 1, 3, 6 and 9 months after intervention commencement
Breast symptoms
Change from baseline in breast symptoms at 1, 3, 6 and 9 months after the intervention commencement, which will be measured with the breast symptoms scale of the EORTC QLQ-BR23 questionnaire validated in Mexico.
Measured: At 1, 3, 6 and 9 months after intervention commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start5 Mar 2024
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Model description
- unblinded, parallel-arm randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Svetlana Doubova, Coordinación de Investigación en Salud, Mexico
- Investigators
- Svetlana V. Doubova, MD. DSc., Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925257
- Sponsor's protocol ID
- R-2021-785-059
- Status last verified
- Oct 2026
- First submitted
- 21 Jun 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study variables will be available.
Publications
Contreras-Sanchez SE, Doubova SV, Grajales-Alvarez R, Villalobos-Valencia R, Dip-Borunda AK, Nunez-Cerrillo JG, Huerta-Lopez AD, Montiel-Jarquin AJ, Garcia-Galicia A, Talamantes-Gomez EI, Sanchez-Reyes RI, Aguirre-Gomez J, Gonzalez-Santiesteban S, Molina-Perez CJ, Leslie HH. Effectiveness of a digital health intervention on the supportive care needs and quality of life in Mexican patients with breast cancer: a randomized clinical trial. BMC Cancer. 2026 Feb 16;26(1):391. doi: 10.1186/s12885-026-15724-w.
PubMed 41692765Contreras Sanchez SE, Doubova SV, Martinez Vega IP, Grajales Alvarez R, Villalobos Valencia R, Dip Borunda AK, Lio Mondragon L, Martinez Pineda WJ, Nunez Cerrillo JG, Huerta Lopez AD, Zalapa Velazquez R, Mendoza Ortiz V, Vazquez Zamora VJ, Montiel Jarquin AJ, Garcia Galicia A, Talamantes Gomez EI, Sanchez Reyes R, Aguirre Gomez J, Ayala Anzures ME, Zapata Tarres M, Monroy A, Leslie HH. Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention. BMJ Open. 2024 Jun 21;14(6):e087240. doi: 10.1136/bmjopen-2024-087240.
PubMed 38908841Contreras Sanchez SE, Doubova SV, Grajales Alvarez R, Dip Borunda AK, Martinez Pineda WJ, Nunez Cerrillo JG, Silva Bravo F, Zalapa Velazquez R, Gutierrez De la Barrera M, Leslie HH. Design and evaluation of a digital health intervention with proactive follow-up by nurses to improve healthcare and outcomes for patients with breast cancer in Mexico: protocol for a randomised clinical trial. BMJ Open. 2023 Nov 6;13(11):e077322. doi: 10.1136/bmjopen-2023-077322.
PubMed 37931967
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Evaluation of the Effectiveness of a Digital Health Intervention to Improve Health Care and Outcomes for Cancer Patients
- ClinicalTrials.gov ID
- NCT05925257
- Acronym / sponsor ID
- R-2021-785-059
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 29 Jun 2023 (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.
Background: Nearly 30,000 Mexican women develop breast cancer annually. These patients frequently present multiple unmet supportive care needs. In high-income settings, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducing unmet needs. No such ePRO interventions have been implemented in Mexico. The objectives of this study are (I) to design a two-component intervention for monitoring ePROs among breast cancer patients using a responsive digital application and proactive follow-up by nurses, (II) to perform intervention pilot testing of the study materials, and (III) to conduct the clinical trial to assess usability and effectiveness of the intervention.
Methods. The investigators designed a two-component intervention for women receiving breast cancer treatment: a responsive web application for monitoring ePROs and clinical algorithms guiding proactive follow-up by nurses. The investigators will conduct a pilot test of the intervention with 50 breast cancer patients for six weeks to assess the feasibility and inform intervention adaptations. After that, the investigators will conduct a parallel arm randomized controlled trial assigning 205 patients each to intervention and control in one of Mexico's largest public oncology hospitals. The intervention will be provided for six months, with additional three months of post-intervention observation. The control group will receive usual healthcare and a list of information sources on relevant breast cancer topics. Women diagnosed with stages I, II, or III breast cancer who initiate chemo and/or radiotherapy will be invited to participate. The study outcomes will include supportive care needs, quality of life, use of emergency services and unscheduled hospitalizations, the usability of the ePRO App, and adherence to the intervention. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6, and 9 months.
Detailed description
An unblinded, parallel-arm, randomized, controlled clinical trial will be conducted. This phase 2 clinical trial focuses on exploring the effect of the intervention on the study variables.The intervention group will be given access to the ePRO application and proactive clinical care, including study nurses responding to ePROs and weekly health information videos for six months. Participants of the control group will be provided with a list of electronic links to videos on breast cancer-relevant topics on the websites of recognised cancer associations and health institutions. All participants will continue to receive the usual health care provided by the hospital. Study intervention wil last 6 months with additional passive folow-up till 9 months to allow post-intervention monitoring.
The participants will be randomly allocated to the intervention or control groups. The minimization technique with MS-DOS Minim program will be used for randomization. It will be conducted by a research assistant who will use a pre-prepared list of random numbers to randomize the first six participants. Starting with the seventh participant, randomization will be carried out using MS-DOS Minim program. The minimization technique is recommended as a standard to ensure that clinical trial groups are similar in terms of participant characteristics, such as age, schooling, breast cancer stage and treatment modality.
Intervention implementation: The lead researcher will weekly obtain the list of breast cancer patients who have started or will start neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy within two weeks in the oncology hospital. The previously trained nurses will use this list to invite all eligible breast cancer patients to participate in the study. Initially, patients will be invited by telephone calls to attend the hospital or the research unit (located at the same medical center as the oncology hospital) to receive the study-related information and to confirm eligibility. Those who meet the inclusion criteria will be provided with the option to participate and invited to provide informed consent prior to participation. Participants will be provided with a username, password, and access to the intervention or control interface of the responsive ePRO App, and training on its use. All participants will be asked to answer the baseline record of sociodemographic and clinical characteristics and questionnaires to assess study outcomes. Intervention arm participants will be asked to complete the weekly register and will receive weekly WhatsApp reminders. Study nurses will contact patients without two weekly records to encourage adherence to the intervention. Study nurses will be supported by the study oncologist/ oncology resident to ensure adherence to the intervention activities. Additionally, the nurses will be in regular contact with the study team and will record their activities in the corresponding interface of the responsive ePRO App.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- unblinded, parallel-arm randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: ePRO application and proactive clinical care with nurses.The intervention group will be given access to the ePRO application and proactive clinical care, including study nurses responding to ePROs and weekly health information videos for six months. |
| Control group | No intervention | –Participants of the control group will be provided with a list of electronic links to videos on breast cancer-relevant topics on the websites of recognised cancer associations and health institutions. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women
- Age between 20 and 75 years
- Breast cancer stages I, II, or III
- Neoadjuvant or adjuvant treatment with chemotherapy that started within two to six weeks before enrollment
- Access to the internet on mobile phone, computer or tablet
Key exclusion criteria (5 listed)
- Illiterate
- Stage IV breast cancer
- Cognitive dysfunction
- Blindness or low vision not corrected with glasses
- Severe depression (≥12 points on the Hospital Anxiety and Depression Scale)
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 |
|---|---|---|
| ePRO application and proactive clinical care with nurses.The investigators defined ePRO intervention as a weekly register of breast cancer patients' symptoms and supportive care needs using the study ePRO App combined with proactive follow-up by nurses guided by predefined clinical algorithms and a weekly cellphone message providing an educational video from a recognised cancer association or health institution. The intervention will be provided for six months with additional three months of post-intervention observation. | Other | Intervention group |
Primary outcome
Health systems and information supportive care needs
Time frame: At 1, 3, 6 and 9 months after intervention commencement
Change from baseline in health systems and information supportive care needs at 1, 3, 6 and 9 months after the intervention commencement, which will be measured with the Supportive Care Needs Survey Short Form-34 (SCNS SF-34) questionnaire validated in Mexico.
2 secondary outcomes
Global quality of life
Time frame: At 1, 3, 6 and 9 months after intervention commencement
Breast symptoms
Time frame: At 1, 3, 6 and 9 months after intervention commencement
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 22 Oct 2026.
- Derived from this study: PubMed 41692765Contreras-Sanchez SE, Doubova SV, Grajales-Alvarez R, Villalobos-Valencia R, Dip-Borunda AK, Nunez-Cerrillo JG, Huerta-Lopez AD, Montiel-Jarquin AJ, Garcia-Galicia A, Talamantes-Gomez EI, Sanchez-Reyes RI, Aguirre-Gomez J, Gonzalez-Santiesteban S, Molina-Perez CJ, Leslie HH. Effectiveness of a digital health intervention on the supportive care needs and quality of life in Mexican patients with breast cancer: a randomized clinical trial. BMC Cancer. 2026 Feb 16;26(1):391. doi: 10.1186/s12885-026-15724-w.
- Derived from this study: PubMed 38908841Contreras Sanchez SE, Doubova SV, Martinez Vega IP, Grajales Alvarez R, Villalobos Valencia R, Dip Borunda AK, Lio Mondragon L, Martinez Pineda WJ, Nunez Cerrillo JG, Huerta Lopez AD, Zalapa Velazquez R, Mendoza Ortiz V, Vazquez Zamora VJ, Montiel Jarquin AJ, Garcia Galicia A, Talamantes Gomez EI, Sanchez Reyes R, Aguirre Gomez J, Ayala Anzures ME, Zapata Tarres M, Monroy A, Leslie HH. Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention. BMJ Open. 2024 Jun 21;14(6):e087240. doi: 10.1136/bmjopen-2024-087240.
- Derived from this study: PubMed 37931967Contreras Sanchez SE, Doubova SV, Grajales Alvarez R, Dip Borunda AK, Martinez Pineda WJ, Nunez Cerrillo JG, Silva Bravo F, Zalapa Velazquez R, Gutierrez De la Barrera M, Leslie HH. Design and evaluation of a digital health intervention with proactive follow-up by nurses to improve healthcare and outcomes for patients with breast cancer in Mexico: protocol for a randomised clinical trial. BMJ Open. 2023 Nov 6;13(11):e077322. doi: 10.1136/bmjopen-2023-077322.
- Individual participant dataSharing planned: Yes. De-identified study variables will be available.
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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.
Svetlana V. Doubova, MD. DSc. principal investigator
Instituto Mexicano del Seguro Social
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePRO application and proactive clinical care with nurses. in people with Breast Cancer, run by Coordinación de Investigación en Salud, Mexico at 3 sites in Mexico.
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 6 inclusion and 5 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. 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?
Health systems and information supportive care needs (time frame: At 1, 3, 6 and 9 months after intervention commencement). 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 NCT05925257, which also lists 3 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 22 Oct 2026.