Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06927102

From Exclusion to Inclusion: Analysing Follow-up Discontinuity 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Basavatarakam Indo American Cancer Hospital & Research Institute

Hyderabad, Telangana, 500034, India

Location status: Recruiting

Location contact

Clinical Trial Manager, B. Pharm

CONTACT

[email protected]

022-23551235

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

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

    Time frame: 6 months

    During outreach, participants will also be asked to identify reasons for missing follow-up visits. These will be documented as qualitative entries.

  2. Assessment of willingness for future hospital contact

    Time frame: 6 months

    Participants will be asked about their willingness to maintain hospital contact in the future and their preferred mode of communication.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Co-ordinator, Pharm D

CONTACT

[email protected]

040-23551235

Sponsors and collaborators

Lead sponsor

Basavatarakam Indo American Cancer Hospital & Research Institute

Other

Registry information

Official study title

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

Acronym: FOCUS-BC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.