MedPath

Finalization and pretesting of a Quality of Life Questionnaire for cancer survivors

Phase 3
Not yet recruiting
Conditions
Malignant neoplasm of nipple and areola, (2) ICD-10 Condition: C819||Hodgkin lymphoma, unspecified, (3) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis,
Registration Number
CTRI/2021/04/032852
Lead Sponsor
The Netherlands Cancer Institute
Brief Summary

With continuing improvement in early detection and treatment and an aging population, the number of cancer survivors is increasing steadily. This has resulted in a growing interest in evaluating the health-related quality of life (HRQOL) of cancer survivors. Many of the cancer-related HRQOL questionnaires that are available today, including the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy – General (FACT-G), with their supplementary site-specific modules, may not entirely appropriate for assessing the experience of disease-free cancer survivors. For this reason, the EORTC Quality of Life Group (QLG) has embarked on a project with the primary objective of developing an HRQOL assessment approach that captures the full range of issues relevant to disease-free cancer survivors, both in general and for specific cancer sites. As of now, the EORTC has arrived at a questionnaire. In this study, we are validating whether the sequence of questions in the questionnaire is correct or not.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
110
Inclusion Criteria
  • INCLUSION CRITERIA: 1.
  • Patients of either gender and aged ≥ 18 years 2.
  • Mentally fit to complete a questionnaire 3.
  • Able to understand the language of the questionnaire 4.
  • Patient is willing to give written informed consent 5.
  • Confirmed cancer diagnosis with one of 11 tumor types 6.
  • Patient has only one cancer diagnosis 7.
  • At least 12 months post-primary treatment with curative intent (exception glioma and maintenance therapies eg tamoxifen) 8.
  • No evidence of active disease (exception glioma grade I, II, and III).
Exclusion Criteria
  • EXCLUSION CRITERIA: 1.
  • Patients not willing to provide written signed informed consent for study participation.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1) Development of a health-related quality of life questionnaire (HRQOL) in cancer survivors.Post 1 year after the end of curative treatment.
Secondary Outcome Measures
NameTimeMethod
1) To determine the minimum time when the survivorship long-term health-related quality of life (HRQOL) questionnaire should be used in cancer survivors after they have completed the curative treatment.1-10 years post the end of curative treatment

Trial Locations

Locations (1)

Tata Memorial Centre

🇮🇳

Mumbai, MAHARASHTRA, India

Tata Memorial Centre
🇮🇳Mumbai, MAHARASHTRA, India
Dr Manjunath Nookala Krishnamurthy
Principal investigator
919920703438
nk.manjunath@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.