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

NCT06927102 | Recruiting

• 1 other identifier: IEC/2024/295
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Keywords

Breast cancer; Follow up; survivorship

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 3. Evaluate the reasons for patient disengagement from follow-up care.

  6 months

• Assessment of willingness for future hospital contact

  6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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:
• \. Patient withdraws consent

Sponsors & Collaborators

• Basavatarakam Indo American Cancer Hospital & Research Institute: lead

Study Sites (1)

Basavatarakam Indo American Cancer Hospital & Research Institute

Hyderabad, Telangana, 500034, India

RECRUITING

Related Publications (1)

• 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.

  PMID: 41334423 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nisha Hariharan, MS,HBNI Fellow Breast Oncology

  Basavatarakam Indo American Cancer Hospital & Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Co-ordinator, Pharm D

CONTACT

040-23551235; research.oncology@basavatarakam.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Breast Oncosurgeon

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

IN (1)