Clinical trial · Observational
Development and Validation of a Health-related Quality of Life Instrument
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focus groups and individual interviews | Other | — | UNRESOLVED |
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- 1A: Content Validation
- description
- 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.
- interventionNames
- Other: Focus groups and individual interviews
- label
- 1B: Face Validity
- description
- 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.
- interventionNames
- Other: Questionnaire
- label
- 2A: To measure test-retest reliability
- description
- Patients to complete FACT-ICM at at two time points separated by 5 to 14 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available