Clinical trial NCT02651831: 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: ICMs
Immune checkpoint modulators
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients who are receiving treatment that modulates immune checkpoints and clinicians with expertise in this area.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 5-14 days
measure: Comparison of FACT-ICM scores between pre-defined groups of patients where differences are expected
timeFrame: 6 months
measure: FACT-ICM change scores from baseline to within 30 days after end of treatment
timeFrame: Baseline, an average of 3 months, and within 30 days after end of treatment
measure: Change in MCID values from baseline to within 30 days after end of treatment
timeFrame: Baseline, an average of 3 months, and within 30 days after treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References: