{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T20:50:14Z","timestamp":1770151814879,"version":"3.49.0"},"reference-count":41,"publisher":"Wiley","issue":"19","license":[{"start":{"date-parts":[[2017,6,5]],"date-time":"2017-06-05T00:00:00Z","timestamp":1496620800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000056","name":"National Institute of Nursing Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000056","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R21NR012716"],"award-info":[{"award-number":["R21NR012716"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2017,10]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>Pediatric participants on phase 1 or phase 2 clinical trials for incurable cancer are at risk of experiencing toxicities (adverse events [AEs]) related to trial participation. Multiple AEs are subjective; thus, the real impact of trial treatment cannot be known unless patient subjective reports are solicited.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>The authors assessed the feasibility and acceptability of soliciting symptom, function, and quality of life (QOL) reports from participants aged 8 to 18 years who were enrolled on phase 1\/2 clinical trials at 4 cancer centers during the first course of chemotherapy. The authors also assessed the reliability and validity of 6 self\u2010report Patient\u2010Reported Outcomes Measurement Information System (PROMIS) pediatric measures and 4 open\u2010ended interview questions at 2 time points (at the time of trial enrollment [T1] and 3 to 4 weeks later [T2]).<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>The enrollment rate of 75.9% (20 participants) exceeded the feasibility criterion, and missingness of measures by person, measure, and items at T1 and T2 were lower than the acceptability criteria. New QOL themes were limited to the impact of treatment on families and being away from home, family, and friends for treatment. All but one measure at T1 met the reliability criterion and all measures did so at T2. Validity support was limited however because as theorized, mobility decreased and fatigue increased as AEs increased.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>Soliciting and documenting symptom, function, and QOL reports from patients aged 8 to 18 years who are enrolled on a phase 1\/2 clinical trial is feasible and acceptable to participants, particularly when embedded in trials. Reliable and valid findings can result, making patient self\u2010reported outcomes a possible new trial endpoint. <jats:bold><jats:italic>Cancer<\/jats:italic> 2017;123:3799\u20133806.<\/jats:bold> \u00a9 <jats:italic>2017 American Cancer Society<\/jats:italic><\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.30782","type":"journal-article","created":{"date-parts":[[2017,6,5]],"date-time":"2017-06-05T11:26:29Z","timestamp":1496661989000},"page":"3799-3806","source":"Crossref","is-referenced-by-count":34,"title":["Voices of children and adolescents on phase 1 or phase 2 cancer trials: A new trial endpoint?"],"prefix":"10.1002","volume":"123","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6491-6649","authenticated-orcid":false,"given":"Pamela S.","family":"Hinds","sequence":"first","affiliation":[{"name":"Department of Nursing Research and Quality Outcomes Children's National Health System Washington DC"},{"name":"Department of Pediatrics George Washington University Washington DC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jichuan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics George Washington University Washington DC"},{"name":"Division of Biostatistics and Study Methodology Children's National Health System Washington DC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily Dunn","family":"Stern","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology Children's National Health System Washington DC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine Fiona","family":"Macpherson","sequence":"additional","affiliation":[{"name":"Nursing Seattle Children's Hospital Seattle Washington"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claire M.","family":"Wharton","sequence":"additional","affiliation":[{"name":"Division of Oncology Seattle Children's Hospital Seattle Washington"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruthanna","family":"Okorosobo","sequence":"additional","affiliation":[{"name":"The George Washington University Washington DC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yao Iris","family":"Cheng","sequence":"additional","affiliation":[{"name":"Division of Biostatistics and Study Methodology Children's National Health System Washington DC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heather E.","family":"Gross","sequence":"additional","affiliation":[{"name":"University of North Carolina at Chapel Hill Chapel Hill North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Holly J.","family":"Meany","sequence":"additional","affiliation":[{"name":"Department of Pediatrics George Washington University Washington DC"},{"name":"Division of Hematology\/Oncology Children's National Health System Washington DC"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shana","family":"Jacobs","sequence":"additional","affiliation":[{"name":"Department of Pediatrics George Washington University Washington DC"},{"name":"Division of Hematology\/Oncology Children's National Health System Washington DC"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,6,5]]},"reference":[{"key":"e_1_2_8_2_1","volume-title":"Cancer Incidence and Survival Among Children and Adolescents: United States SEER Program 1975\u20101995. 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