From Exclusion to Inclusion: Analysing Follow-up Discontinuity in Breast Cancer (FOCUS-BC)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma

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).

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Clinical Trial Co-ordinator, Pharm D; Phone Number: 040-23551235; Email: research.oncology@basavatarakam.org

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • Recruiting
      • Basavatarakam Indo American Cancer Hospital & Research Institute
      • Contact: Clinical Trial Manager, B. Pharm; Phone Number: 022-23551235; Email: research.oncology@basavatarakam.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months

Collaborators and Investigators

• Sponsor: Basavatarakam Indo American Cancer Hospital & Research Institute
• Investigators: Principal Investigator: Nisha Hariharan, MS,HBNI Fellow Breast Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 13, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; survivorship; Follow up
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: IEC/2024/295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No