From Exclusion to Inclusion: Analysing Follow-up Discontinuity in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comprehensive Analysis of Follow-up Outcomes, Continuity and Updated Survivorship in Breast Cancer
Overview
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).
Primary outcome measures
- Improvement in follow-up data with proactive outreach [Time frame: 6 months]
- Updated mortality data [Time frame: 6 months]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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:
1\. Patient withdraws consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
India · 1 center
- Basavatarakam Indo American Cancer Hospital & Research Institute — Hyderabad
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. PMID 41334423
Identifiers
NCT: NCT06927102 · IEC/2024/295