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Study of patient reported outcomes in breast and gynaecologic cancer patients undergoing systemic chemotherapy

Study of patient reported outcomes in breast and gynaecologic cancer patients undergoing systemic chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/01/011075
Enrollment
3100
Registered
2018-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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 and Gynaecology Cancer

Interventions

None listed

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with breast or gynaecologic cancer undergoing systemic chemotherapy under Department of Medical Oncology, Tata Memorial Centre will be eligible for recruitment. 2. Histologically confirmed invasive/metastatic carcinoma of the breast or gynaecologic malignancy. 3. ECOG /PS 0-2 at study entry 4. Age 18 to 65 years 5. Patient willing to participate and sign ICF

Exclusion criteria

Exclusion criteria: 1. Not consenting for participation or not willing to fill-up the study questionnaire 2. Patients undergoing an investigational therapy

Design outcomes

Primary

MeasureTime frame
To identify adverse effects and distressing symptoms of breast and gynaecologic patients undergoing systemic therapy and analysing their effects on the patient, by recording them using a Patient Reported Outcomes (PROs) questionnaire, specially designed and tested for validity and reliability in an initial pilot study. Incidence of symptoms: Pain, Vomiting, Diarrhoea, Constipation, Tingling/Numbness, Appetite loss, Fatigue, Hot flushes, Soreness of mouth, other.Timepoint: To identify adverse effects and distressing symptoms of breast and gynaecologic patients undergoing systemic therapy and analysing their effects on the patient, by recording them using a Patient Reported Outcomes (PROs) questionnaire, specially designed and tested for validity and reliability in an initial pilot study. Incidence of symptoms: Pain, Vomiting, Diarrhoea, Constipation, Tingling/Numbness, Appetite loss, Fatigue, Hot flushes, Soreness of mouth, other.

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactMr Yogesh Kembhavi

Tata Memorial Centre

sudeepgupta04@yahoo.com

Outcome results

None listed

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