NCT06856876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

February 26, 2025

Last Update Submit

March 4, 2025

Conditions

Keywords

Breast CancerMDCTDisease free survivalQuality of lifeoutcome

Outcome Measures

Primary Outcomes (2)

  • Disease-Free Survival (DFS)

    Time from the start of treatment to the first occurrence of disease relapse, progression, or death from any cause.

    24 months (measured at 6, 12, 18, and 24 months)

  • Overall survival

    Time from the start of treatment until death from any cause.

    24 months (measured at 6, 12, 18, and 24 months)

Secondary Outcomes (2)

  • Recurrence rate

    24 months (measured at 6, 12, 18, and 24 months)

  • Complication rate

    24 months (measured at 6, 12, 18, and 24 months)

Study Arms (2)

MDCT (Group A)

EXPERIMENTAL

Participants receive multidisciplinary care team (MDCT) treatment, including personalized treatment plans developed by oncologists, radiologists, and surgeons.

Other: Multidisciplinary Care Team (MDCT) Approach

Standard Therapy (Group B)

ACTIVE COMPARATOR

Participants receive standard care for breast cancer according to the current institutional protocols.

Other: Standard Breast Cancer Therapy

Interventions

A personalized breast cancer treatment plan developed through regular case discussions by a team of radiologists, oncologists, and surgeons. The MDCT coordinates patient support services and tracks treatment progress according to evidence-based guidelines.

Also known as: MDCT
MDCT (Group A)

Breast cancer treatment provided according to the institutional protocols at Hayatabad Medical Complex, including standard surgery, chemotherapy, and/or radiotherapy as clinically indicated.

Also known as: Standard Therapy
Standard Therapy (Group B)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly biologically female patients diagnosed with breast cancer are eligible to participate
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All female patients, diagnosed with breast cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayatabad Medical Complex

Peshawar, KPK, 25000, Pakistan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Patient Care TeamStandard of Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services AdministrationQuality Indicators, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Yousaf Jan, MBBS, FCPS, FRCS, MRCS, ECFMG

    Hayat Abad Medical Complex, Peshawar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 26, 2025

First Posted

March 4, 2025

Study Start

May 1, 2021

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD) due to confidentiality concerns and institutional policies.

Locations