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

Cancer Clinical Trial

— FACT-ICM  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651831
• Other study ID #: FACT-ICM
• Status: Completed
• Start date: July 2015
• Est. completion date: January 2024

Study information

• Verified date: January 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Comparison of FACT-ICM scores between pre-defined groups of patients where differences are expected		6 months
Secondary	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
Secondary	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