Development and Validation of a Health-related Quality of Life Instrument (FACT-ICM)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1A: Content Validation
Up to 4 focus groups of 6-10 cancer patients each will be conducted each lasting approximately 90 mins. An additional 10 to 15 patients will undergo individual semi-structured interviews each lasting around 60 minutes. 10-12 expert clinicians experienced in treating patients with ICMs or managing ICM toxicities will participate in a survey, and group or 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.
|
|
1B: Face Validity
Patients who have been and are being treated with ICMs to complete draft questionnaire (FACT-ICM).
Some patients who were involved in the first round of interviews will be re-interviewed, and interview naïve patients will also be included.
|
Health related quality of life questionnaire (FACT-ICM) to be completed by patients
|
|
2A: To measure test-retest reliability
Patients to complete FACT-ICM at at two time points separated by 5 to 14 days.
|
Health related quality of life questionnaire (FACT-ICM) to be completed by patients
|
|
2B: To confirm construct validity
To evaluate discriminative properties of FACT-ICM, scores will be compared between pre-defined groups of patients where differences are expected.
|
Health related quality of life questionnaire (FACT-ICM) to be completed by patients
|
|
2C: To determine responsiveness and MCID
Responsiveness testing: Patients will complete FACT-ICM within a week of starting treatment, then while on treatment and within 30 days after end of treatment (EOT) with ICMs. MCID testing: In addition to the FACT-ICM score, patients undergoing serial assessment for responsiveness will also indicate how much better or worse they are using a 5-point rating scale. |
Health related quality of life questionnaire (FACT-ICM) to be completed by patients
|
What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome 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
Time Frame: 5-14 days
|
5-14 days
|
|
Comparison of FACT-ICM scores between pre-defined groups of patients where differences are expected
Time Frame: 6 months
|
6 months
|
|
FACT-ICM change scores from baseline to within 30 days after end of treatment
Time Frame: Baseline, an average of 3 months, and 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
Time Frame: Baseline, an average of 3 months, and within 30 days after treatment
|
Baseline, an average of 3 months, and within 30 days after treatment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FACT-ICM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.