Development and Validation of a Health-related Quality of Life Instrument (FACT-ICM)

January 14, 2024 updated by: University Health Network, Toronto

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).

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Estimated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
Other: Questionnaire
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.
Other: Questionnaire
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.
Other: Questionnaire
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.
Other: Questionnaire
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

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimated)

January 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 14, 2024

Last Verified

January 1, 2024

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.

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