Breast CancerNCT06597773
Online Patient Navigation Program for Patients With Breast Cancer
A study testing Online patient navigation and supportive care referrals and In-person patient navigation and supportive care referrals in people with Breast Cancer and Supportive Care in Cancer, run by Medicos e Investigadores en la Lucha contra el Cancer de Mama at 1 site in Mexico.
Trial summary
The goal of this prospective 1:1 randomized controlled trial is to evaluate if an online patient navigation program, designed to identify targeted supportive care needs and to facilitate referrals and web-based interventions to address these needs, can increase patients' access to supportive care services, compared to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Supportive Care in Cancer, Patient Navigation
- What is being tested?
- Online patient navigation and supportive care referrals and In-person patient navigation and supportive care referrals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 21 Sep 2025to 23 Sep 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex
- Age ≥18 years
- Diagnosis of non-metastatic breast cancer
- Internet access at home or in their mobile phone
- Availability to answer the study surveys
- Provision of signed informed consent
Who cannot join
- Disease recurrence
- Inability to read or write
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Zambrano Hellion
San Pedro Garza García, Nuevo León, 66260
About this study
Official title: Online Patient Navigation Program for Timely Access to Supportive Care Services Among Patients With Breast Cancer
The goal of this prospective 1:1 randomized controlled trial is to evaluate if an online patient navigation program, designed to identify targeted supportive care needs and to facilitate referrals and web-based interventions to address these needs, can increase patients' access to supportive care services, compared to traditional in-person patient navigation providing referrals to in-person supportive care services.
The main questions it aims to answer are:
Read more
- Does online patient navigation increase access to supportive care services among patients with breast cancer?
- Which are the barriers that hinder patients' access to the supportive care services they require?
- What is patients' level of satisfaction with online patient navigation?
Participants will:
- Participate in an online or in-person patient navigation program for 4 weeks
- Answer the study surveys at baseline and 4 weeks of follow-up
- Conditions
- Breast Cancer, Supportive Care in Cancer, Patient Navigation
- Being tested
- Online patient navigation and supportive care referrals, In-person patient navigation and supportive care referrals
- Keywords
- breast cancer, supportive care, patient navigation, online patient navigation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online patient navigation and supportive care referralsOther
In the online patient navigation program, a navigator will use validated instruments to identify participants\' need for nutrition, psychology, and sexology counseling, and will refer them to the required services. Referrals will be made to web-based, systematic supportive care resources consisting of pre-recorded videos led by specialists and which will be available on a study-specific website, allowing each participant to access the resources as soon as they receive a referral. Additionally, online support groups will be held monthly to complement the supportive care programs.
In-person patient navigation and supportive care referralsOther
In the in-person patient navigation program, a navigator will use validated instruments to identify participants\' need for nutrition, psychology, and sexology counseling, and will refer them to the required services. Referrals will be made to supportive care services available at their healthcare institution.
| Study group | Role | What they receive |
|---|---|---|
| Online patient navigation and supportive care referrals | Experimental | The intervention group will participate in an online patient navigation program designed to identify patients' nutrition, psychology, and sexology counseling needs, and to facilitate referrals and web-based systematic interventions to address these supportive care needs.
Participants in this group will complete the study surveys at baseline (T1) and 4 weeks (T2) of follow-up. Receives: Other: Online patient navigation and supportive care referrals |
| In-person patient navigation and supportive care referrals | Active comparator | The control group will participate in an in-person patient navigation program designed to identify patients' nutrition, psychology, and sexology counseling needs, and to facilitate referrals to in-person supportive care services.
Participants in this group will complete the study surveys at baseline (T1) and 4 weeks (T2) of follow-up. Receives: Other: In-person patient navigation and supportive care referrals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access to supportive care services
Participants' rate of attendance to each of the supportive care services in study will be evaluated through a survey at 4 weeks of follow-up, which will assess each group's access to the recommended services, barriers encountered, and satisfaction with the navigation program.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Sep 2025
- Primary completion22 Sep 2025 (estimated)
- Study completion23 Sep 2025
Why it stopped: It was not possible to develop and implement the intervention due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicos e Investigadores en la Lucha contra el Cancer de Mama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Mesa-Chavez, Medicos e Investigadores en la Lucha contra el Cancer de Mama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597773
- Sponsor's protocol ID
- ECA-Navegacion
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Patient Navigation Program for Timely Access to Supportive Care Services Among Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06597773
- Acronym / sponsor ID
- ECA-Navegacion
- Conditions
- Breast Cancer, Supportive Care in Cancer, Patient Navigation
- Keywords
- breast cancer, supportive care, patient navigation, online patient navigation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was not possible to develop and implement the intervention due to lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medicos e Investigadores en la Lucha contra el Cancer de MamaUniversity, hospital or other
- Study start
- 21 Sep 2025 (actual)
- Primary completion
- 22 Sep 2025 (estimated)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective 1:1 randomized controlled trial is to evaluate if an online patient navigation program, designed to identify targeted supportive care needs and to facilitate referrals and web-based interventions to address these needs, can increase patients' access to supportive care services, compared to traditional in-person patient navigation providing referrals to in-person supportive care services.
The main questions it aims to answer are:
- Does online patient navigation increase access to supportive care services among patients with breast cancer?
- Which are the barriers that hinder patients' access to the supportive care services they require?
- What is patients' level of satisfaction with online patient navigation?
Participants will:
- Participate in an online or in-person patient navigation program for 4 weeks
- Answer the study surveys at baseline and 4 weeks of follow-up
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online patient navigation and supportive care referrals | Experimental | Other: Online patient navigation and supportive care referralsThe intervention group will participate in an online patient navigation program designed to identify patients' nutrition, psychology, and sexology counseling needs, and to facilitate referrals and web-based systematic interventions to address these supportive care needs. Participants in this group will complete the study surveys at baseline (T1) and 4 weeks (T2) of follow-up. |
| In-person patient navigation and supportive care referrals | Active comparator | Other: In-person patient navigation and supportive care referralsThe control group will participate in an in-person patient navigation program designed to identify patients' nutrition, psychology, and sexology counseling needs, and to facilitate referrals to in-person supportive care services. Participants in this group will complete the study surveys at baseline (T1) and 4 weeks (T2) of follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female sex
- Age ≥18 years
- Diagnosis of non-metastatic breast cancer
- Internet access at home or in their mobile phone
- Availability to answer the study surveys
Key exclusion criteria (2 listed)
- Disease recurrence
- Inability to read or write
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 |
|---|---|---|
| Online patient navigation and supportive care referralsIn the online patient navigation program, a navigator will use validated instruments to identify participants\' need for nutrition, psychology, and sexology counseling, and will refer them to the required services. Referrals will be made to web-based, systematic supportive care resources consisting of pre-recorded videos led by specialists and which will be available on a study-specific website, allowing each participant to access the resources as soon as they receive a referral. Additionally, online support groups will be held monthly to complement the supportive care programs. | Other | Online patient navigation and supportive care referrals |
| In-person patient navigation and supportive care referralsIn the in-person patient navigation program, a navigator will use validated instruments to identify participants\' need for nutrition, psychology, and sexology counseling, and will refer them to the required services. Referrals will be made to supportive care services available at their healthcare institution. | Other | In-person patient navigation and supportive care referrals |
Primary outcome
Access to supportive care services
Time frame: 4 weeks
Participants' rate of attendance to each of the supportive care services in study will be evaluated through a survey at 4 weeks of follow-up, which will assess each group's access to the recommended services, barriers encountered, and satisfaction with the navigation program.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online patient navigation and supportive care referrals and In-person patient navigation and supportive care referrals in people with Breast Cancer and Supportive Care in Cancer, run by Medicos e Investigadores en la Lucha contra el Cancer de Mama at 1 site 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 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2025. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Access to supportive care services (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2025.