METHODS: A targeted search (focused on PROMs used in oncology clinical trials) identified oncology (pan-tumor), tumor-site specific, and generic PROMs used to assess symptoms and/or health-related quality of life impacts in the selected early-stage cancers. PROMs were initially reviewed for face validity and conceptual coverage (against a preliminary conceptual model developed based on a targeted qualitative literature review of these same tumor-types). This informed the selection of PROMs that were subsequently reviewed for content validity and psychometric properties. PROMs were assessed according to established standards for the development and validation of PROMs.

RESULTS: Twenty-four PROMs were initially reviewed, which had strong evidence of face validity and conceptual coverage when evaluated against concepts most frequently reported in qualitative research in the selected early-stage cancers. Eighteen oncology-specific PROMs were reviewed further. Evidence of qualitative research with early-stage cancer patients to inform PROM development or retrospective work to support concept relevance in early-stage cancer was varied. Evidence for the psychometric properties of included PROMs (where available) was based on analyses conducted primarily in mixed-stage samples, with limited evidence specifically in early-stage populations. Most PROMs had evidence supporting scale-level reliability and validity (n=17/18), but only some had evidence supporting instrument structure (n=8/18) or established meaningful change thresholds (n=8/18).