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Clinical Trials/CTRI/2024/02/062342
CTRI/2024/02/062342
Completed
Not Applicable

Study on psychological distress and health related quality of life among women with gynecological cancers at a tertiary care hospital in Udupi, Karnataka

Poonam pinto1 site in 1 country292 target enrollmentStarted: February 10, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Poonam pinto
Enrollment
292
Locations
1
Primary Endpoint
Study aims to evaluate psychological distress in women with gynecological cancers.

Overview

Brief Summary

The aim of this study is to asses level of psychological distress and health related quality of life among women with gynecological cancers. This study will use validated tools, Kessler Psychological Distress Scale (K10) and EORTC QLQ-C30, to assess psychological distress and health-related quality of life in gynecological cancer patients of stages 1 to 3. The study will focus on 292 women, aged 18 and above, diagnosed with cervical and ovarian cancer at a tertiary hospital, However, they won’t include patients with a history of psychiatric disorders or those in stage 4 of cervical or ovarian cancer, regardless of their critical condition. Patients from both in-patient and out-patient settings will be interviewed privately after obtaining consent and explaining the study. Researchers will administer the questionnaires, ensuring confidentiality. The collected data, gathered in a single session, will be analyzed using suitable statistical methods.

This study intends to explore the psychological distress levels in women with gynecological cancers, focusing on anxiety and depression. Additionally, it aims to evaluate the health-related quality of life by asking about their physical and mental well-being.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Women aged 18 years above diagnosed with cervical and ovarian cancer at tertiary Hospital Women with stages 1 and 2 and 3 of cervical and ovarian cancer who are both in-patients and out-patients at tertiary hospital.

Exclusion Criteria

  • Patients with a history of psychiatric disorder Stage 4 of all the cervical and ovarian cancer and who are critically ill irrespective of their stage of cancer.

Outcomes

Primary Outcomes

Study aims to evaluate psychological distress in women with gynecological cancers.

Time Frame: 3 months from data collection

Secondary Outcomes

  • Study assess health-related quality of life in women with gynecological cancers.(3 months from data collection)

Investigators

Sponsor
Poonam pinto
Sponsor Class
Other [Self funded]
Responsible Party
Principal Investigator
Principal Investigator

Poonam Pinto

Prasanna School of Public Health

Study Sites (1)

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