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Patient preference matters in decision making for surgery for breast cancer

A Randiomized Controlled Trial of Navya Patient preference Tool - An Online Self Administered Adaptive conjoint Analysis Based Decision Aid,for women undergoing surgery for early Breast Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/11/010480
Enrollment
255
Registered
2017-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Breast Cancer

Interventions

None listed

Sponsors

TMC Research Administrative Council
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Women with histologically proven breast cancer (by core biopsy/FNAC/excision biopsy) 2 Upfront operable cT1,T2N0 breast cancer 3 Eligible for Breast Conservation (absence of multicentricity or extensive microcalcifications in mammogram), as deemed at surgical planning evaluation of the patient after complete diagnostic data is gathered by the DMG. 4 Written, informed consent

Exclusion criteria

Exclusion criteria: 1 Patients under 18 of years of age 2 Patients who are pregnant 3 Patients who cannot comprehend the questionnaire due to psychiatric illness or inability to understand the study consent

Design outcomes

Primary

MeasureTime frame
The primary outcome is the Decisional Conflict Index (DCI).Secondary outcomes are Patient Satisfaction Scale, Rate of BCT Vs Mastectomy, Concordance with Navya Patient Preference Tool, and Concordance with Physician, Follow through with Decision (Compliance).Timepoint: The time of surgery

Secondary

MeasureTime frame
Secondary outcomes are Patient Satisfaction Scale, Rate of BCT Vs Mastectomy, Concordance with Navya Patient Preference Tool, and Concordance with Physician, Follow through with Decision (Compliance)Timepoint: the time of surgery

Countries

India

Contacts

Public ContactDr Shalaka Joshi

Tata Memorial Hospital

tmc.bcdmg15@gmail.com02221468601

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 8, 2026