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

NCT ID: NCT02651831

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2024-01-31

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.

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.

Conditions

Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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 and individual interviews

Intervention Type: 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.

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.

Questionnaire

Intervention Type: OTHER

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.

Questionnaire

Intervention Type: OTHER

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.

Questionnaire

Intervention Type: OTHER

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.

Questionnaire

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Questionnaire

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

FACT-ICM

Identifier Type: -

Identifier Source: org_study_id