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Improving Chemotherapy Safety and Quality of Life in Breast Cancer Patients Using a Standardized Chemotherapy Order Form: A Study by an Onco-Pharmacist

Onco-Pharmacist Led Study on the Impact of Standardized Chemotherapy Order Template on Medication Safety and Quality of Life in Breast Cancer Patients in a Tertiary Care Hospital: A Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088343
Enrollment
280
Registered
2025-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Intervention-COT: The Chemotherapy Order Template (COT) serves as the core intervention in this clinical study, specifically designed to improve medication management and therapeutic ou

Sponsors

Mr Patil Vivek Nilkanth
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects aged above 18(Adult Population). Subjects who Histologically/Pathologically diagnosed with Breast cancer. Subjects undergoing chemotherapy.

Exclusion criteria

Exclusion criteria: Subjects with less than 6 months life expectancy. Subjects who are not willing to participate.Subjects who are suffering with any psychiatric illness/ Non co-operative subjects

Design outcomes

Primary

MeasureTime frame
The primary outcome is to assess the impact of a standardized Chemotherapy Order Template (COT) on improving safety and quality of care in breast cancer patients by reducing drug-related problems (DRPs). The COT will be developed, validated, and used in the intervention group. DRPs will be identified using a standard classification system and measured throughout treatment. This outcome may also guide sample size estimation.Timepoint: 1 Year

Secondary

MeasureTime frame
The study assesses medication appropriateness using the MAI to ensure patients receive safe & suitable treatment. Quality of life will be evaluated using the FACT-G questionnaire, covering physical, emotional, & social well-being. As a secondary outcome, quality of life will be measured at multiple time points before, during, & after chemotherapy to understand treatment impact & improve overall care for breast cancer patients.Timepoint: 1 Year

Countries

India

Contacts

Public ContactDr M S Ganachari

KLE College of Pharmacy Belagavi

msganachari@gmail.com9448634457

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026