Clinical trial NCT06856876: Examining the Effectiveness of Multidisciplinary Care Teams in Improving Outcomes for Breast Cancer Patients
Official title: Examining the Effectiveness of Multidisciplinary Care Teams in Improving Outcomes for Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancers
Breast Cancer Female
Breast Cancer Stage I
Keywords: Breast Cancer
MDCT
Disease free survival
Quality of life
outcome
Lead sponsor: Hayat Abad Medical Complex, Peshawar.
Sponsor class: OTHER_GOV
First posted: 2025-03-04
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-Free Survival (DFS)
timeFrame: 24 months (measured at 6, 12, 18, and 24 months)
measure: Overall survival
timeFrame: 24 months (measured at 6, 12, 18, and 24 months)
Secondary outcomes:
measure: Recurrence rate
timeFrame: 24 months (measured at 6, 12, 18, and 24 months)
measure: Complication rate
timeFrame: 24 months (measured at 6, 12, 18, and 24 months)
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Hayatabad Medical Complex
state: KPK
Study officials:
affiliation: Hayat Abad Medical Complex, Peshawar.
name: Yousaf Jan, MBBS, FCPS, FRCS, MRCS, ECFMG
role: PRINCIPAL_INVESTIGATOR
References: