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From Exclusion to Inclusion: Analysing Follow-up Discontinuity in Breast Cancer

A Comprehensive Analysis of Follow-up Outcomes, Continuity and Updated Survivorship in Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06927102
Acronym
FOCUS-BC
Enrollment
1500
Registered
2025-04-15
Start date
2025-05-01
Completion date
2025-10-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

Keywords

Breast cancer, Follow up, survivorship

Brief 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. 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. 1. 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. 2. 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. 3. 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).

Interventions

None listed

Sponsors

Basavatarakam Indo American Cancer Hospital & Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients newly diagnosed with non-metastatic breast cancer between 2017-2018 2. Patients categorized as lost-to-follow-up, as defined above 3. Patients willing to participate upon re-engagement

Exclusion criteria

1. Patients with incomplete medical records 2. Patients who have taken part of the treatment at another hospital/centre 3. Patients who have relocated permanently out of the study region Withdrawal Criteria: 1\. Patient withdraws consent

Design outcomes

Primary

MeasureTime frameDescription
Improvement in follow-up data with proactive outreach6 monthsFollow-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 data6 monthsFor 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.

Secondary

MeasureTime frameDescription
3. Evaluate the reasons for patient disengagement from follow-up care.6 monthsDuring outreach, participants will also be asked to identify reasons for missing follow-up visits. These will be documented as qualitative entries.
Assessment of willingness for future hospital contact6 monthsParticipants will be asked about their willingness to maintain hospital contact in the future and their preferred mode of communication.

Countries

India

Contacts

Primary ContactClinical Trial Co-ordinator, Pharm D
research.oncology@basavatarakam.org040-23551235

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026