Examining the Effectiveness of Multidisciplinary Care Teams in Improving Outcomes for Breast Cancer Patients

Not Applicable

Completed

• Conditions: Breast Cancers; Breast Cancer Female; Breast Cancer Stage I

• Registration Number: NCT06856876
• Lead Sponsor: Yousaf Jan

Brief Summary

To compare clinical outcomes, patient-reported measures (PROMs), and healthcare utilization between standard care with or without an MDCT in a cohort of women treated for breast cancer.

Detailed Description

This single-center, prospective interventional trial evaluates the effectiveness of Multidisciplinary Care Teams (MDCTs) in improving outcomes for newly diagnosed breast cancer patients at Hayatabad Medical Complex, Peshawar. The study enrolled 73 participants from May 2021 to April 2024, with follow-up sessions every six months for up to two years.

Participants were randomly assigned to two groups:

Group A (n=37): Received care through MDCTs, which included radiologists, oncologists, and surgeons collaborating to create personalized treatment plans and monitor patient progress.

Group B (n=36): Received standard therapy according to existing institutional protocols.

The study assesses multiple outcomes, including \*\*disease-free survival (DFS), overall survival (OS), recurrence rates, complication rates, patient-reported outcomes (PROs), quality of life (measured via SF-36), and healthcare utilization.

Statistical analyses include Kaplan-Meier survival curves, log-rank tests, Cox proportional hazards regression models, repeated-measures ANOVA, and linear regression models to identify predictors of survival and quality of life.

The study protocol was approved by the Institutional Review Board (IRB) and complies with the Declaration of Helsinki. All participants provided informed consent prior to enrollment.

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Status Verified: 2025-03
• Study First Posted: 2025-03-04
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

Inclusion Criteria

All female patients, diagnosed with breast cancer

Exclusion Criteria

Previous treatment for breast cancer, concurrent enrollment in another clinical research, and serious medical conditions that could affect study outcomes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival (DFS)	24 months (measured at 6, 12, 18, and 24 months)	Time from the start of treatment to the first occurrence of disease relapse, progression, or death from any cause.
Overall survival	24 months (measured at 6, 12, 18, and 24 months)	Time from the start of treatment until death from any cause.

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	24 months (measured at 6, 12, 18, and 24 months)	Number of participants with local or distant breast cancer recurrence.
Complication rate	24 months (measured at 6, 12, 18, and 24 months)	Incidence of treatment-related complications (e.g., surgical site infections, chemotherapy side effects).

Trial Locations

Locations (1)

Hayatabad Medical Complex; 🇵🇰 Peshawar, KPK, Pakistan