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

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ClinicalTrials.gov Identifier: NCT02651831
Recruitment Status : Recruiting
First Posted : January 11, 2016
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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.

Condition or disease Intervention/treatment
Cancer Other: Focus groups and individual interviews Other: Questionnaire

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 Design
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Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : July 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Comparison of FACT-ICM scores between pre-defined groups of patients where differences are expected [ Time Frame: 6 months ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651831


Contacts
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Contact: Aaron Hansen, MD (416) 946-4501 ext 5606

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Aaron Hansen, M.D.    (416) 946-4501 ext 5606      
Principal Investigator: Aaron Hansen, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02651831     History of Changes
Other Study ID Numbers: FACT-ICM
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

Keywords provided by University Health Network, Toronto:
ICMs
Immune checkpoint modulators