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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDCT (Group A) | Experimental | Participants receive multidisciplinary care team (MDCT) treatment, including personalized treatment plans developed by oncologists, radiologists, and surgeons. |
|
| Standard Therapy (Group B) | Active Comparator | Participants receive standard care for breast cancer according to the current institutional protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary Care Team (MDCT) Approach | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Number of participants with local or distant breast cancer recurrence. | 24 months (measured at 6, 12, 18, and 24 months) |
| Complication rate | Incidence of treatment-related complications (e.g., surgical site infections, chemotherapy side effects). |
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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
Only biologically female patients diagnosed with breast cancer are eligible to participate
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| Name | Affiliation | Role |
|---|---|---|
| Yousaf Jan, MBBS, FCPS, FRCS, MRCS, ECFMG | Hayat Abad Medical Complex, Peshawar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hayatabad Medical Complex | Peshawar | KPK | 25000 | Pakistan |
There is no plan to share individual participant data (IPD) due to confidentiality concerns and institutional policies.
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|
|
| Standard Breast Cancer Therapy | Other | Breast cancer treatment provided according to the institutional protocols at Hayatabad Medical Complex, including standard surgery, chemotherapy, and/or radiotherapy as clinically indicated. |
|
|
| 24 months (measured at 6, 12, 18, and 24 months) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D010348 | Patient Care Team |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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