PMID- 37589994
OWN - NLM
STAT- Publisher
LR  - 20231012
IS  - 2168-619X (Electronic)
IS  - 2168-6181 (Print)
IS  - 2168-6181 (Linking)
VI  - 149
IP  - 10
DP  - 2023 Oct 1
TI  - Monitoring Adverse Effects of Radiation Therapy in Patients With Head and Neck 
      Cancer: The FACT-HN-RAD Patient-Reported Outcome Measure.
PG  - 884-890
LID - 10.1001/jamaoto.2023.2177 [doi]
AB  - IMPORTANCE: Patients undergoing radiation therapy (RT) for head and neck squamous 
      cell carcinoma (HNSCC) experience a range of debilitating adverse effects (AEs). 
      Patient-reported outcome (PRO) measures to quantify these AEs are a necessary and 
      important component of health care; however, currently available PRO options 
      often measure only disease-related symptoms or AEs of non-RT treatments. 
      OBJECTIVE: To develop a brief PRO measure of the most common AEs associated with 
      RT for HNSCC. DESIGN, SETTING, AND PARTICIPANTS: This was a qualitative study 
      that followed the US Food and Drug Administration guidelines to develop a brief 
      measure of patient-reported RT-related AEs (the Functional Assessment of Cancer 
      Therapy-Head and Neck Radiotherapy [FACT-HN-RAD] measure). The study included (1) 
      a literature review of clinical trials; (2) secondary analysis of retrospective 
      concept elicitation interviews (CEIs); (3) electronic surveys of practicing 
      radiation oncologists; (4) mapping of existing items to inform the development of 
      the draft version of the measure; and (5) validation of content and face validity 
      via patient cognitive interviews. Analysis was performed of CEI data and 
      interviews with practicing radiation oncologists. Data analysis was conducted 
      from July 1, 2022, to April 21, 2023. EXPOSURES: Surveys and qualitative 
      interviews. MAIN OUTCOMES AND MEASURES: The most common patient-reported 
      RT-related AEs among patients with HNSCC. RESULTS: Of 19 CEI participants, 14 
      (mean [range] age, 67 [49-86] years; 12 [86%] men and 2 [14%] women) described 
      RT-related AEs and were included in the secondary analysis. Eleven (79%) patients 
      reported difficulty swallowing; 8 (57%), oral pain; 7 (50%), dry mouth; 7 (50%), 
      weight loss; 6 (43%), skin burning; 5 (36%), loss of taste; 5 (36%), voice 
      changes (36%); and 5 (36%), fatigue. Nine radiation oncologists (mean [range] 
      time in practice, 8 [1-42] years; 5 [56%] men and 4 [44%] women) reported the 
      most common AEs: 9 (100%) reported dysgeusia; 7 (78%), xerostomia; 7 (78%), 
      mucositis or oral pain; 8 (89%), dysphagia or odynophagia; 6 (67%), dermatitis; 
      and 3 (33%), fatigue. Together these data informed the development of an 8-item 
      AE-focused measure of pain, dysphagia, xerostomia, dysgeusia, voice changes, 
      dermatitis, fatigue, and weight loss. Cognitive interviews with 10 patients (mean 
      [range] age, 61 [29-84] years; 8 [80%] men and 2 [20%] women) demonstrated strong 
      face validity; all (100%) reported that the measure reflected their experience 
      with RT and stated that the length of the questionnaire was "just right." 
      CONCLUSIONS AND RELEVANCE: The 8-item FACT-HN-RAD measure captures the most 
      common patient- and physician-reported AEs related to RT for HNSCC. This measure 
      offers a means to serially monitor patient-reported treatment-related AEs and 
      recovery over time in both clinical and research settings. Future work will 
      evaluate the psychometric validity of the measure.
FAU - Gharzai, Laila A
AU  - Gharzai LA
AD  - Department of Radiation Oncology, Northwestern University, Chicago, Illinois.
AD  - Department of Medical Social Sciences, Northwestern University, Chicago, 
      Illinois.
FAU - Mierzwa, Michelle L
AU  - Mierzwa ML
AD  - Department of Radiation Oncology, University of Michigan, Ann Arbor.
FAU - Peipert, John Devin
AU  - Peipert JD
AD  - Department of Medical Social Sciences, Northwestern University, Chicago, 
      Illinois.
FAU - Kirtane, Kedar
AU  - Kirtane K
AD  - Department of Medical Oncology, Moffitt Cancer Center, Tampa, Florida.
FAU - Casper, Keith
AU  - Casper K
AD  - Department of Otolaryngology, University of Michigan, Ann Arbor.
FAU - Yadav, Poonam
AU  - Yadav P
AD  - Department of Radiation Oncology, Northwestern University, Chicago, Illinois.
FAU - Rothrock, Nan
AU  - Rothrock N
AD  - Department of Medical Social Sciences, Northwestern University, Chicago, 
      Illinois.
FAU - Cella, David
AU  - Cella D
AD  - Department of Medical Social Sciences, Northwestern University, Chicago, 
      Illinois.
FAU - Shaunfield, Sara
AU  - Shaunfield S
AD  - Department of Medical Social Sciences, Northwestern University, Chicago, 
      Illinois.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - JAMA Otolaryngol Head Neck Surg
JT  - JAMA otolaryngology-- head & neck surgery
JID - 101589542
SB  - IM
PMC - PMC10436187
COIS- Conflict of Interest Disclosures: Dr Kirtane reported personal fees from A2Bio 
      outside the submitted work. Dr Yadav reported grants from Viewray outside the 
      submitted work. Dr Cella reported serving as president of FACIT.org outside the 
      submitted work. Dr Shaunfield reported grants from Daiichi Sankyo during the 
      conduct of the study. No other disclosures were reported.
EDAT- 2023/08/17 12:43
MHDA- 2023/08/17 12:43
PMCR- 2024/08/17
CRDT- 2023/08/17 11:33
PHST- 2024/08/17 00:00 [pmc-release]
PHST- 2023/08/17 12:43 [pubmed]
PHST- 2023/08/17 12:43 [medline]
PHST- 2023/08/17 11:33 [entrez]
AID - 2808658 [pii]
AID - ooi230050 [pii]
AID - 10.1001/jamaoto.2023.2177 [doi]
PST - ppublish
SO  - JAMA Otolaryngol Head Neck Surg. 2023 Oct 1;149(10):884-890. doi: 
      10.1001/jamaoto.2023.2177.