Cancer
Conditions
Keywords
ICMs, Immune checkpoint modulators
Brief 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.
Detailed description
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.
Interventions
OTHERQuestionnaire
Health related quality of life questionnaire (FACT-ICM) to be completed by patients
OTHERFocus 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.
Sponsors
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient Criteria * Cancer diagnosis (any type, advanced or metastatic stage); * Treatment with an agent or agents that modulate an immune checkpoint (any line of therapy); * Age ≥ 18; * English-speaking; * ECOG PS 0-3 * Able to complete questionnaires independently * Able to provide informed consent. * Completed treatment within a year of enrolment Clinician Criteria * Must either treat patients with ICMs or manage side effects of patients treated with ICMs * Be able to attend interviews and participate in discussions as part of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 5-14 days |
| Comparison of FACT-ICM scores between pre-defined groups of patients where differences are expected | 6 months |
| FACT-ICM change scores from baseline to within 30 days after end of treatment | Baseline, an average of 3 months, and within 30 days after end of treatment |
| Change in MCID values from baseline to within 30 days after end of treatment | Baseline, an average of 3 months, and within 30 days after treatment |
Countries
Canada
Outcome results
None listed