- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06856876
Examining the Effectiveness of Multidisciplinary Care Teams in Improving Outcomes for Breast Cancer Patients (MDCT)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KPK
-
Peshawar, KPK, Pakistan, 25000
- Hayatabad Medical Complex
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MDCT (Group A)
Participants receive multidisciplinary care team (MDCT) treatment, including personalized treatment plans developed by oncologists, radiologists, and surgeons.
|
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.
Other Names:
|
|
Active Comparator: Standard Therapy (Group B)
Participants receive standard care for breast cancer according to the current institutional protocols.
|
Breast cancer treatment provided according to the institutional protocols at Hayatabad Medical Complex, including standard surgery, chemotherapy, and/or radiotherapy as clinically indicated.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease-Free Survival (DFS)
Time Frame: 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.
|
24 months (measured at 6, 12, 18, and 24 months)
|
|
Overall survival
Time Frame: 24 months (measured at 6, 12, 18, and 24 months)
|
Time from the start of treatment until death from any cause.
|
24 months (measured at 6, 12, 18, and 24 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence rate
Time Frame: 24 months (measured at 6, 12, 18, and 24 months)
|
Number of participants with local or distant breast cancer recurrence.
|
24 months (measured at 6, 12, 18, and 24 months)
|
|
Complication rate
Time Frame: 24 months (measured at 6, 12, 18, and 24 months)
|
Incidence of treatment-related complications (e.g., surgical site infections, chemotherapy side effects).
|
24 months (measured at 6, 12, 18, and 24 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yousaf Jan, MBBS, FCPS, FRCS, MRCS, ECFMG, Hayat Abad Medical Complex, Peshawar.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMCKP2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer Stage I
-
Mayo ClinicNational Cancer Institute (NCI)CompletedAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Prognostic Stage I Breast Cancer AJCC v8 | Prognostic Stage IA Breast Cancer AJCC v8 | Prognostic Stage IB Breast Cancer AJCC v8 | Prognostic Stage IIA Breast Cancer AJCC...United States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedStage I Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
National Cancer Institute (NCI)CompletedStage I Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
City of Hope Medical CenterTerminatedStage I Breast Cancer | Cancer Survivor | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Ohio State University Comprehensive Cancer CenterNot yet recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic Stage IV Breast Cancer AJCC v8 | Chemotherapy-Induced AlopeciaUnited States
-
Indiana University School of MedicineBreast Cancer Research FoundationCompletedQuantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer (EPC)Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage IIUnited States
-
Craig A. Bunnell, MD, MPHMassachusetts General Hospital; Dana-Farber Cancer Institute; Beth Israel Deaconess... and other collaboratorsCompletedBreast Cancer | Stage I Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast CancerUnited States
-
Mayo ClinicNot yet recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Cancer-related Cognitive DysfunctionUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Early Stage Triple-Negative Breast Carcinoma | Early Stage HER2-Positive Breast CarcinomaUnited States
Clinical Trials on Multidisciplinary Care Team (MDCT) Approach
-
The University of Texas Health Science Center,...DHR Health Institute for Research and DevelopmentCompletedType 2 DiabetesUnited States
-
National Institute of Diabetes and Digestive and...Completed
-
University of AdelaideCentral Adelaide Local Health Network IncorporatedCompletedObesity | Bariatric Surgery Candidate
-
Chinese University of Hong KongCompletedType 2 Diabetes Mellitus | DM NephropathyChina
-
George Washington UniversityCompletedHeart Failure | Chronic Kidney DiseasesUnited States
-
Hendrick Medical CenterAbbottNot yet recruitingPeripheral Arterial Disease | Amputation | Critical Limb Ischemia
-
Kaiser PermanenteGarfield Memorial FundCompletedLiver Failure | Acquired Immunodeficiency Syndrome | Stroke | Pneumonia | Diabetes Mellitus | Cancer | Pulmonary Disease, Chronic Obstructive | Respiratory Failure | Renal Failure | Dementia | Kidney Failure, Chronic | Coronary Arteriosclerosis | Cerebrovascular Accident | Failure to Thrive | Heart Failure, CongestiveUnited States
-
Shanxi Province Cancer HospitalCompletedLung Neoplasms | Small Cell Lung Cancer | Extensive-Stage Small Cell Lung CancerChina
-
University of WashingtonPatient-Centered Outcomes Research InstituteCompletedPTSD | Physical InjuryUnited States
-
University of AlbertaAlberta Heritage Foundation for Medical ResearchTerminated