“QUALITY OF LIFE OF Ca OVARY PATIENTS REFEREED FROM PRIMARY OR SECONDARY HEALTH CENTERâ€

Recruiting

• Conditions: Malignant neoplasm of unspecifiedovary,

• Registration Number: CTRI/2016/11/007490
• Lead Sponsor: NOT APPLICABLE

Brief Summary

All patients who satisfy the inclusion criteria and sign the informed consent to participate in the study will be served the Quality of Life questionnaires (EORTC QLQ-C30 and QLQ-OV28) in the language which they know (English, Hindi, Marathi).

 QOL will be measure through the quality of life questionnaires(QLQ) i.e QLQ-C30 and QLQ-OV28 at baseline, after surgery, after completion of all chemotherapy cycle, after 3 months of completion of adjuvant chemotherapy and subsequently every 6 months till 2 years(Total 6 assessments of QOL modules).

At the time of each module assessment, we will record patients nutritional parameters like BMI, serum hemoglobin and albumin levels. We will also do chemo-toxicity assessment as and when applicable.

The outcome (Quality of life) will be assessed using the questionnaires of Quality of life analysis - European Organization for Research and Treatment of cancer (EORTC) QLQ-C30 and QLQ- OV28 questionnaire to study a quality of life in Ca ovary patients. There will be two subsets, those who are getting treatment with curative intent and the other one with palliative intent which will be separately analyzed.

This study will give us insight about QOL of Ca ovary patients treated at our center.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-15
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Ca ovary patients whose age is above 18 years and have consented to undergo treatment at Tata Memorial Centre, after adequate staging workup.

Exclusion Criteria

• •Patients who do not meet the above criteria.
• •Patients unwilling to participate in the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To detect, the impact of chemotherapy, on the quality of life of Ca Ovary patients treated with curative intent.	The outcome (Quality of life) will be assessed using the questionnaires of Quality of life analysis - European Organization for Research and Treatment of cancer (EORTC) QLQ-C30 and QLQ- OV28 questionnaire to study a quality of life in Ca ovary patients. There will be two subsets, those who are getting treatment with curative intent and the other one with palliative intent which will be separately analyzed.
2.To detect, the impact of chemotherapy, on the quality of life of Ca Ovary patients treated with palliative intent.	The outcome (Quality of life) will be assessed using the questionnaires of Quality of life analysis - European Organization for Research and Treatment of cancer (EORTC) QLQ-C30 and QLQ- OV28 questionnaire to study a quality of life in Ca ovary patients. There will be two subsets, those who are getting treatment with curative intent and the other one with palliative intent which will be separately analyzed.

Secondary Outcome Measures

Name	Time	Method
This study will give us insight about QOL of Ca ovary patients treated at our center.	QOL will be measure through the quality of life questionnaires(QLQ) i.e QLQ-C30 and QLQ-OV28 at baseline, after surgery, after completion of all chemotherapy cycle, after 3 months of completion of adjuvant chemotherapy and subsequently every 6 months till 2 years(Total 6 assessments of QOL modules).

Trial Locations

Locations (1)

Tata Memorial Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Centre

🇮🇳Mumbai, MAHARASHTRA, India

Dr Jyoti Bajpai

Principal investigator

02224177287

dr_jyotibajpai@yahoo.co.in