Clinical trial NCT06927102: From Exclusion to Inclusion: Analysing Follow-up Discontinuity in Breast Cancer
Official title: A Comprehensive Analysis of Follow-up Outcomes, Continuity and Updated Survivorship in Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Carcinoma
Keywords: Breast cancer
Follow up
survivorship
Lead sponsor: Basavatarakam Indo American Cancer Hospital & Research Institute
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in follow-up data with proactive outreach
timeFrame: 6 months
measure: Updated mortality data
timeFrame: 6 months
Secondary outcomes:
measure: 3. Evaluate the reasons for patient disengagement from follow-up care.
timeFrame: 6 months
measure: Assessment of willingness for future hospital contact
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Basavatarakam Indo American Cancer Hospital & Research Institute
name: Nisha Hariharan, MS,HBNI Fellow Breast Oncology
role: PRINCIPAL_INVESTIGATOR
References: