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

NCT02651831 | Completed

• 1 other identifier: FACT-ICM
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

ICMs; Immune checkpoint modulators

Outcome Measures

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

  6 months

Secondary Outcomes (4)

• 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

  5-14 days

• Comparison of FACT-ICM scores between pre-defined groups of patients where differences are expected

  6 months

• FACT-ICM change scores from baseline to 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

  Baseline, an average of 3 months, and within 30 days after treatment

Study Arms (5)

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

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

2A: To measure test-retest reliability

Patients to complete FACT-ICM at at two time points separated by 5 to 14 days.

Other: Questionnaire

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

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

Interventions

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.

1A: Content Validation

Questionnaire OTHER

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

1B: Face Validity; 2A: To measure test-retest reliability; 2B: To confirm construct validity; 2C: To determine responsiveness and MCID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Focus Groups; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 11, 2016
• Study Start: July 1, 2015
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

CA (1)