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

Official Title

Development and Validation of a Health-related Quality of Life Instrument: Functional Assessment of Cancer Therapy - Immune Checkpoint Modulators, an Investigator Initiated Study (FACT-ICM).

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.

Trial Description

Primary Outcome:

• Confirmatory factor analysis of FACT-ICM PRO tool variables compared to content analysis and qualitative descriptives of patient focus groups and interviews in target group

Secondary Outcome:

• Change of score for each domain and also the total FACT-ICM score at baseline to 5-14 days for patients with minimal change in status
• Comparison of FACT-ICM scores between pre-defined groups of patients where differences are expected
• FACT-ICM change scores from baseline to within 30 days after end of treatment
• Change in MCID values from baseline to within 30 days after end of treatment

Immune Checkpoint Modulators (ICMs) are associated with significant adverse events. Currently there are no validated patient reported outcome (PRO) tools to assess health related quality of life (HRQOL) specifically in patients receiving ICMs. HRQOL is a multidimensional concept of a patient's perceived well-being that can be affected by disease and treatment. There is an urgent need to assess the impact of ICMs on HRQOL, to better understand the balance between efficacy and toxicity with these agents. This study aims to develop a health related quality of life (HRQOL) patient reported outcome (PRO) for patients receiving immune checkpoint inhibitor (ICM) therapy (FACT-ICM). The core domains of the FACT-ICM will include physical, emotional, family and social, and functional well being. In addition, the proposed study will develop a toxicity sub-scale related to resultant toxicities from ICM therapy. The HRQOL will be developed through focus groups and interviews with patients treated with ICMs, and clinicians treating patients with ICMs, to understand how treatment with ICMs impacts HRQOL, as well as explore general experiences, insights and concerns of those receiving ICM therapies.

View this trial on ClinicalTrials.gov