Breast CarcinomaFOCUS-BCNCT06927102
From Exclusion to Inclusion: Analysing Follow-up Discontinuity in Breast Cancer
An observational study of Breast Carcinoma, run by Basavatarakam Indo American Cancer Hospital & Research Institute at 1 site in India.
Trial summary
The goal of this observational study is to determine the proportion of patients who are lost-to-follow-up at five years, identify factors associated with loss of follow-up , and explore patient-reported barriers to follow-up in a public sector cancer care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma
- How many people
- 1,500 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2025to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective cohort study involving women diagnosed with non-metastatic breast cancer in the years 2017-2018, who received treatment at our institute, Basavatarakam Indo American Cancer Hospital \& Research Institute, Hyderabad, India.
Who may be able to join
- Patients newly diagnosed with non-metastatic breast cancer between 2017-2018
- Patients categorized as "lost-to-follow-up", as defined above
- Patients willing to participate upon re-engagement
Who cannot join
- Patients with incomplete medical records
- Patients who have taken part of the treatment at another hospital/centre
- Patients who have relocated permanently out of the study region
- Withdrawal Criteria:
- 1. Patient withdraws consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Basavatarakam Indo American Cancer Hospital & Research Institute
Hyderabad, Telangana, 500034
Clinical Trial Manager, B. Pharm, 022-23551235, research.oncology@basavatarakam.org
About this study
Official title: A Comprehensive Analysis of Follow-up Outcomes, Continuity and Updated Survivorship in Breast Cancer
The goal of this observational study is to determine the proportion of patients who are lost-to-follow-up at five years, identify factors associated with loss of follow-up , and explore patient-reported barriers to follow-up in a public sector cancer care setting.
The main question it aims to answer is : Do proactive outreach programs help in improving follow-up rates among breast cancer patients who are categorized as "lost-to-follow-up." This study will be conducted in a real-world cohort of women with non-metastatic breast cancer treated at a tertiary care centre, between 2017-2018.
Read the detailed description
This is a prospective cohort study involving women diagnosed with non-metastatic breast cancer in the years 2017-2018, who received treatment at our institute. Baseline data collection will include essential demographic information, clinical data including tumor characteristics, stage at presentation and luminal subtype and treatment information including surgical intervention, chemotherapy, radiotherapy, hormonal therapy, and targeted therapy.
The study will be conducted in three phases.
- Phase I: Quantitative Follow-Up Analysis Follow-up data will be retrieved from hospital records and electronic medical records (EMR) up to December 2024. Follow-up visits will be documented annually through to the end of 2024.
- Phase II: Assessment of Lost to Follow-Up (LTFU) Cases For patients identified as LTFU (definitions provided below), additional variables will be extracted, including geographic distance from the hospital, mode of employment, marital status, and payment method (government scheme, insurance, or self-pay). Proactive outreach efforts will be undertaken via phone calls, messages, or emails using contact information available in hospital records. Informed consent will be obtained in cases where contact has been successfully established - verbally for phone calls and in writing for electronic communication. Patients (or their families) will be queried about current health status, recent diagnostic evaluations, recurrence of disease, or mortality (if applicable). These responses will be documented as valid follow-up entries.
- Phase III: Qualitative Analysis of LTFU Reasons During outreach, participants will also be asked to identify reasons for missing follow-up visits. These will be categorized under the following domains: Logistical barriers (e.g., travel, time constraints), financial constraints, availability of alternative/local healthcare facilities, physician recommendations, lack of awareness regarding the importance of follow-up. In addition, participants will be asked about their willingness to maintain hospital contact in the future and their preferred mode of communication (e.g., phone, SMS, email, video call).
- Conditions
- Breast Carcinoma
- Keywords
- Breast cancer, Follow up, survivorship
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| New, non-metastatic, breast cancer patients between 2017-2018 | All women with newly diagnosed non-metastatic breast cancer, presenting to Basavatarakam Indo American Cancer Hospital \& Research Institute, Hyderabad, India, between 2017 - 2018 will be included in the study. The analysis will focus on the women who have been lost-to-follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in follow-up data with proactive outreach
Follow-up data will be retrieved from hospital records and electronic medical records (EMR) up to December 2024. For patients identified as lost-to-follow-up, proactive outreach efforts will be undertaken via phone calls, messages, or emails. Patients (or their families) will be queried about recurrence of disease, and these responses will be documented as valid follow-up entries.
Measured: 6 months
Updated mortality data
For patients identified as lost-to-follow-up, proactive outreach efforts will be undertaken via phone calls, messages, or emails. Patients (or their families) will be queried about mortality (if applicable) and these responses will be documented as valid follow-up entries.
Measured: 6 months
Secondary outcomes (2)
3. Evaluate the reasons for patient disengagement from follow-up care.
During outreach, participants will also be asked to identify reasons for missing follow-up visits. These will be documented as qualitative entries.
Measured: 6 months
Assessment of willingness for future hospital contact
Participants will be asked about their willingness to maintain hospital contact in the future and their preferred mode of communication.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 May 2025
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basavatarakam Indo American Cancer Hospital & Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisha Hariharan, Basavatarakam Indo American Cancer Hospital & Research Institute
- Investigators
- Nisha Hariharan, MS,HBNI Fellow Breast Oncology, Principal investigator, Basavatarakam Indo American Cancer Hospital & Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927102
- Sponsor's protocol ID
- IEC/2024/295
- Acronym
- FOCUS-BC
- Status last verified
- Sep 2025
- First submitted
- 7 Apr 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Since this study involves contacting women who are lost-to-follow-up, the investigators are considering various options for sharing IPD, with appropriate consent from the participants.
Publications
Hariharan N, Rao TS, Rajappa SJ, Naidu CK, Rayani B, Kodandapani S, Koppula V, Gudipudi D. From exclusion to inclusion: Analysis of patterns of follow-up in breast cancer. Int J Surg Protoc. 2025 Sep 8;29(4):156-160. doi: 10.1097/SP9.0000000000000061. eCollection 2025 Dec.
PubMed 41334423
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Analysis of Follow-up Outcomes, Continuity and Updated Survivorship in Breast Cancer
- ClinicalTrials.gov ID
- NCT06927102
- Acronym / sponsor ID
- FOCUS-BC / IEC/2024/295
- Conditions
- Breast Carcinoma
- Keywords
- Breast cancer, Follow up, survivorship
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Basavatarakam Indo American Cancer Hospital & Research InstituteUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 Apr 2025 (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 observational study is to determine the proportion of patients who are lost-to-follow-up at five years, identify factors associated with loss of follow-up , and explore patient-reported barriers to follow-up in a public sector cancer care setting.
The main question it aims to answer is : Do proactive outreach programs help in improving follow-up rates among breast cancer patients who are categorized as "lost-to-follow-up." This study will be conducted in a real-world cohort of women with non-metastatic breast cancer treated at a tertiary care centre, between 2017-2018.
Detailed description
This is a prospective cohort study involving women diagnosed with non-metastatic breast cancer in the years 2017-2018, who received treatment at our institute. Baseline data collection will include essential demographic information, clinical data including tumor characteristics, stage at presentation and luminal subtype and treatment information including surgical intervention, chemotherapy, radiotherapy, hormonal therapy, and targeted therapy.
The study will be conducted in three phases.
- Phase I: Quantitative Follow-Up Analysis Follow-up data will be retrieved from hospital records and electronic medical records (EMR) up to December 2024. Follow-up visits will be documented annually through to the end of 2024.
- Phase II: Assessment of Lost to Follow-Up (LTFU) Cases For patients identified as LTFU (definitions provided below), additional variables will be extracted, including geographic distance from the hospital, mode of employment, marital status, and payment method (government scheme, insurance, or self-pay). Proactive outreach efforts will be undertaken via phone calls, messages, or emails using contact information available in hospital records. Informed consent will be obtained in cases where contact has been successfully established - verbally for phone calls and in writing for electronic communication. Patients (or their families) will be queried about current health status, recent diagnostic evaluations, recurrence of disease, or mortality (if applicable). These responses will be documented as valid follow-up entries.
- Phase III: Qualitative Analysis of LTFU Reasons During outreach, participants will also be asked to identify reasons for missing follow-up visits. These will be categorized under the following domains: Logistical barriers (e.g., travel, time constraints), financial constraints, availability of alternative/local healthcare facilities, physician recommendations, lack of awareness regarding the importance of follow-up. In addition, participants will be asked about their willingness to maintain hospital contact in the future and their preferred mode of communication (e.g., phone, SMS, email, video call).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New, non-metastatic, breast cancer patients between 2017-2018 | – | –All women with newly diagnosed non-metastatic breast cancer, presenting to Basavatarakam Indo American Cancer Hospital \& Research Institute, Hyderabad, India, between 2017 - 2018 will be included in the study. The analysis will focus on the women who have been lost-to-follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective cohort study involving women diagnosed with non-metastatic breast cancer in the years 2017-2018, who received treatment at our institute, Basavatarakam Indo American Cancer Hospital \& Research Institute, Hyderabad, India.
Key inclusion criteria (3 listed)
- Patients newly diagnosed with non-metastatic breast cancer between 2017-2018
- Patients categorized as "lost-to-follow-up", as defined above
- Patients willing to participate upon re-engagement
Key exclusion criteria (5 listed)
- Patients with incomplete medical records
- Patients who have taken part of the treatment at another hospital/centre
- Patients who have relocated permanently out of the study region
- 1. Patient withdraws consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement in follow-up data with proactive outreach
Time frame: 6 months
Follow-up data will be retrieved from hospital records and electronic medical records (EMR) up to December 2024. For patients identified as lost-to-follow-up, proactive outreach efforts will be undertaken via phone calls, messages, or emails. Patients (or their families) will be queried about recurrence of disease, and these responses will be documented as valid follow-up entries.
Updated mortality data
Time frame: 6 months
For patients identified as lost-to-follow-up, proactive outreach efforts will be undertaken via phone calls, messages, or emails. Patients (or their families) will be queried about mortality (if applicable) and these responses will be documented as valid follow-up entries.
2 secondary outcomes
3. Evaluate the reasons for patient disengagement from follow-up care.
Time frame: 6 months
Assessment of willingness for future hospital contact
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 41334423Hariharan N, Rao TS, Rajappa SJ, Naidu CK, Rayani B, Kodandapani S, Koppula V, Gudipudi D. From exclusion to inclusion: Analysis of patterns of follow-up in breast cancer. Int J Surg Protoc. 2025 Sep 8;29(4):156-160. doi: 10.1097/SP9.0000000000000061. eCollection 2025 Dec.
- Individual participant dataSharing planned: Undecided. Since this study involves contacting women who are lost-to-follow-up, the investigators are considering various options for sharing IPD, with appropriate consent from the participants.
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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.
Nisha Hariharan, MS,HBNI Fellow Breast Oncology principal investigator
Basavatarakam Indo American Cancer Hospital & Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Basavatarakam Indo American Cancer Hospital & Research Institute at 1 site in India.
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 3 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: looking for participants now, as of the sponsor's last update on 19 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 India. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Co-ordinator, Pharm D (040-23551235, research.oncology@basavatarakam.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in follow-up data with proactive outreach (time frame: 6 months). The study lists 2 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 NCT06927102, which also lists 1 linked publication.
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 19 Sep 2025.