Breast Cancer Female, Breast Cancers, Breast Cancer Stage I
Conditions
Keywords
Breast Cancer, MDCT, Disease free survival, Quality of life, outcome
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.
Interventions
OTHERMultidisciplinary Care Team (MDCT) Approach
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.
OTHERStandard Breast Cancer Therapy
Breast cancer treatment provided according to the institutional protocols at Hayatabad Medical Complex, including standard surgery, chemotherapy, and/or radiotherapy as clinically indicated.
Sponsors
Yousaf Jan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Pakistan
Outcome results
None listed