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Completed

NCT Number: NCT02651831

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focus groups and individual interviews

Other

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

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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).

Acronym: FACT-ICM

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2016
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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