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Development and Validation of a Health-related Quality of Life Instrument

NCT02651831 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2024-01-17

No results posted yet for this study

Summary

This study aims to develop a health related quality of life (HRQOL) patient reported outcome (PRO) for patients receiving immune checkpoint modulator (ICM) therapy. This instrument could be used to in clinical trials to evaluate HRQOL for patients treated with novel ICMs and ICM combinations that might ultimately influence decisions about regulatory approval, as well as improved understanding of chronic treatment effects on patient well-being, understanding reasons for treatment non-adherence, and developing strategies to improve adherence and evaluating clinical outcomes.

Conditions

Interventions

OTHER

Focus groups and individual interviews

Focus groups conducted to explore general experiences, insights and concerns of those receiving ICM therapies. Individual semi-structured interviews to provide in-depth data on the themes identified in the focus groups.

OTHER

Questionnaire

Health related quality of life questionnaire (FACT-ICM) to be completed by patients

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02651831 on ClinicalTrials.gov