Facets of physical function assessed by patient-reported outcome measures in oncology research.

PURPOSE: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and classify the PROMs by content covered (facets of PF) in each measure. METHODS: As part of the Patient Reports of Physical Functioning Study (PROPS) research program, we conducted a targeted literature review to identify PROMs that could be used in clinical trials to evaluate PF from the patient perspective. Next, we convened an advisory panel to conduct a modified, reactive, Delphi study to reach consensus on which PF facets are assessed by PROMs identified in the review. The panel engaged in a "card sort" activity to classify PROM items by PF facets. Consensus was reached when 80% of panel members agreed that at least one facet was being measured by each PROM item. RESULTS: The literature review identified 13 PROMs that met inclusion criteria. Eight facets of PF were identified for classification in the Delphi study: ability, completion, difficulty, limitation, quality, frequency, bother, and satisfaction. Through two rounds, the panel documented and classified conceptual approaches for each PRO item presented. The most prevalent PF facets were ability, difficulty, and limitation. CONCLUSION: Classifying PF PROMs by PF facets will promote more consistent communication regarding the aspects of PF represented in each PROM, helping researchers prioritize measures for inclusion in cancer clinical trials.

What facets of physical function are most important to adults diagnosed with cancer?

PURPOSE: Successful patient-focused drug development involves selecting and measuring outcomes in clinical trials that are important to patients. The U.S. Food & Drug Administration's definition of clinical benefit includes how patients feel, function, or survive. Patients are considered the experts in describing how they feel and function. In cancer trials, patient-reported measures of physical function provide insight into how patients function at baseline, benefit from the interventions being studied, and the impact of treatment side effects. We conducted a qualitative study with adults diagnosed with cancer to describe facets of physical function from their perspective and to identify which facets are most important to this patient population. METHODS: Using concept elicitation and cognitive interviewing techniques, we conducted semi-structured interviews with 72 adults ≥ 22 years of age with cancer who received treatment with an anticancer drug or biologic within six months of the interview. We selected participants using purposive sampling with the aim to elicit diverse experiences regarding how they may interpret and respond to questions related to physical function. Participants were presented with patient-reported outcome (PRO) items representative of PRO measures used in cancer and general populations. RESULTS: Five facets of how physical function relates to activities were defined from the patient perspective: ability, difficulty, limitation, satisfaction, and completion. More than half of the participants indicated that ability was the most important facet of physical function. The next most important were satisfaction (18.3%), limitation (14.1%), difficulty (5.6%), and completion (2.8%). CONCLUSION: This study demonstrates that we must be more specific about the facets of physical function that we set out to assess when we use PRO measures to describe the patient experience. These results have implications for the specificity of physical function facets when measured in cancer clinical trials.

Emotional and functional well-being in long-term breast cancer survivorship.

PURPOSE: Emotional and functional well-being (EWB and FWB) are important components of mental health and quality of life. This study aims to evaluate long-term EWB and FWB in breast cancer (BC) survivors. METHODS: The Carolina Breast Cancer Study Phase 3 oversampled Black and younger (< 50 years in age) women so that they each represent approximately 50% of the study population and assessed participants' EWB and FWB with the Functional Assessment of Cancer Therapy-Breast (FACT-B) at 5- (baseline), 25-, and 84-months post diagnosis. Multinomial logit models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for associations between demographic and clinical characteristics and well-being change relative to baseline. RESULTS: Among 2,781 participants with BC, average EWB and FWB improved with time since diagnosis. Persistent FWB decrements were associated with Black race [OR 1.4 (95% CI 1.2-1.7) and 1.3 (95% CI 1.1-1.6), at 25-months and 84-months respectively], older age [OR 1.4 (95% CI 1.1-1.7) and 1.5 (95% CI 1.2-1.8), respectively], no chemotherapy, and recurrence [OR 2.9 (95% CI 1.8-4.8) and 3.1 (95% CI 2.1-4.6), respectively]. EWB decrements were associated with advanced stage and recurrence. Decrements in combined (FWB+EWB) well-being were associated with recurrence at both follow-up survey timepoints [ORs 4.7 (95% CI 2.7-8.0) and 4.3 (95% CI 2.8-6.6), respectively]. CONCLUSIONS: Long-term well-being varies by demographics and clinical features, with Black women and women with aggressive disease at greatest risk of long-term decrements.

Systematic Literature Review of Health-Related Quality-of-Life Measures for Caregivers of Older Adult Trauma Patients.

INTRODUCTION: As the older adult population increases, hospitals treat more older adults with injuries. After leaving, these patients suffer from decreased mobility and independence, relying on care from others. Family members often assume this responsibility, mostly informally and unpaid. Caregivers of other older adult populations have increased stress and decreased caregiver-related quality of life (CRQoL). Validated CRQoL measures are essential to capture their unique experiences. Our objective was to review existing CRQoL measures and their validity in caregivers of older adult trauma patients. METHODS: A professional librarian searched published literature from the inception of databases through August 12, 2022 in MEDLINE (via PubMed), Embase (via Elsevier), and CINAHL Complete (via EBSCO). We identified 1063 unique studies of CRQoL in caregivers for adults with injury and performed a systematic review following COnsensus-based Standards for the selection of health Measurement Instruments guidelines for CRQoL measures. RESULTS: From the 66 studies included, we identified 54 health-related quality-of-life measures and 60 domains capturing caregiver-centered concerns. The majority (83%) of measures included six or fewer CRQoL content domains. Six measures were used in caregivers of older adults with single-system injuries. There were no validated CRQoL measures among caregivers of older adult trauma patients with multisystem injuries. CONCLUSIONS: While many measures exist to assess healthcare-related quality of life, few, if any, adequately assess concerns among caregivers of older adult trauma patients. We found that CRQoL domains, including mental health, emotional health, social functioning, and relationships, are most commonly assessed among caregivers. Future measures should focus on reliability and validity in this specific population to guide interventions.

Demographic and Clinical Factors Associated With Health-Related Quality-of-Life Profiles Among Prostate Cancer Survivors.

PURPOSE: Our purpose was to describe the prevalence and predictors of symptom and function clusters related to physical, emotional, and social components of general health-related quality of life (HRQOL) in a population-based sample of prostate cancer (PCa) survivors. METHODS: Participants (N = 1,162) completed a baseline survey at a median of 9 months after diagnosis to ascertain the co-occurrence of eight symptom and functional domains that are common across all cancers and not treatment-specific. We used latent profile analysis (LPA) to identify subgroup profiles of survivors with low, moderate, or high HRQOL levels. Multinomial logistic regression models were used to identify clinical and sociodemographic factors associated with survivors' membership in the low versus moderate or high HRQOL profile. RESULTS: The LPA identified 16% of survivors who were categorized in the low HRQOL profile at baseline, indicative of the highest symptom burden and lowest functioning. Factors related to survivors' membership in the low versus higher HRQOL profile groups included less than age 65 years at diagnosis, identifying as non-Hispanic Black race, not working, being a former versus never smoker, systemic therapy, less companionship, more comorbidities, lower health care financial well-being, or less spirituality. Several factors remained associated with remaining in the low versus higher HRQOL profiles on the follow-up survey (n = 699), including younger age, Black race, comorbidity, and lower financial and spiritual well-being. CONCLUSION: About one of six PCa survivors experienced elevated physical and psychosocial symptoms that were independent of local curative therapy, but with younger age, race, comorbidity, and lower financial and spiritual well-being as stable risk factors for poor HRQOL over time.

Development of an ultra-short measure of eight domains of health-related quality of life for research and clinical care: the patient-reported outcomes measurement information system® PROMIS®-16 profile.

PURPOSE: We describe development of a short health-related quality of life measure, the patient-reported outcomes measurement information system® (PROMIS®)-16 Profile, which generates domain-specific scores for physical function, ability to participate in social roles and activities, anxiety, depression, sleep disturbance, pain interference, cognitive function, and fatigue. METHODS: An empirical evaluation of 50 candidate PROMIS items and item pairs was conducted using data from a sample of 5775 respondents from Amazon's Mechanical Turk (MTurk). Results and item response theory information curves for a subset of item pairs were presented and discussed in a stakeholder meeting to narrow the candidate item sets. A survey of the stakeholders and 124 MTurk adults was conducted to solicit preferences among remaining candidate items and finalize the measure. RESULTS: Empirical evaluation showed minimal differences in basic descriptive statistics (e.g., means, correlations) and associations with the PROMIS-29 + 2 Profile, thus item pairs were further considered primarily based on item properties and content. Stakeholders discussed and identified subsets of candidate item pairs for six domains, and final item pairs were agreed upon for two domains. Final items were selected based on stakeholder and MTurk-respondent preferences. The PROMIS-16 profile generates eight domain scores with strong psychometric properties. CONCLUSION: The PROMIS-16 Profile provides an attractive brief measure of eight distinct domains of health-related quality of life, representing an ideal screening tool for clinical care, which can help clinicians quickly identify distinct areas of concern that may require further assessment and follow-up. Further research is needed to confirm and extend these findings.

Protocol for the development of a Core Outcome Set (COS) for Adolescents and Young Adults (AYAs) with cancer.

BACKGROUND: Adolescents and young adults (AYAs) with cancer, defined as individuals aged 15-39 years at initial cancer diagnosis, form a unique population; they face age-specific issues as they transition to adulthood. This paper presents the protocol for the development of a core outcome set (COS) for AYAs with cancer. METHODS: The methodological standards from the Core Outcome Measures in Effectiveness Trials (COMET) and the International Consortium for Health Outcomes Measurement (ICHOM) for COS development will guide the development of the COS for AYAs with cancer. The project will consist of the following phases: (1) define the scope of the COS; (2) establish the need for a COS in this field (3) assemble an international, multi-stakeholder working group; (4) develop a detailed protocol; (5) determine "what to measure" (i.e., outcomes); (6) determine "how to measure" (i.e., measures); and (7) determine "case-mix" variables. CONCLUSIONS: The development of a COS for AYAs with cancer will facilitate the implementation of efficient and relevant standards for data collection, both for clinical trials and in routine healthcare, thereby increasing the usefulness of these data to improve the value of the care given to these underserved young cancer patients.

Facilitators and barriers to eliciting physical function goals before and after surgery: A qualitative study with clinicians.

OBJECTIVE: Describe clinicians' perspectives of facilitators and barriers to eliciting physical function goals from patients with multiple chronic conditions pre- and post-surgery. METHODS: Semi-structured qualitative interviews were conducted with clinicians, recruited from an academic medical center, who treat adult patients with multiple chronic conditions. Purposive sampling ensured multiple provider types were represented. Interviews were conducted in person or via web conference and were audio recorded. Findings were summarized using descriptive qualitative content analysis. RESULTS: Of the 12 participating clinicians, 92% were female and 83% specialized in geriatrics. Clinicians had a mean of 10.7 (min-max: 1-30) years of experience. Key facilitators to goal-setting conversations were sufficient time, familial support, and patient cognitive ability. Barriers included lack of time, lack of training, patient challenges in choosing realistic and specific actionable goals, emotional barriers, and cognitive challenges. CONCLUSION: Some facilitators and barriers are modifiable, including time, inclusion of family members in the clinical encounter, and clinician training to enable actionable goal setting. These results highlight areas for intervention to facilitate goal elicitation for physical function in clinical care settings. PRACTICE IMPLICATIONS: Clinicians should be aware of the barriers impacting eliciting goals. Healthcare organizations could consider providing effective goal elicitation training and tools to facilitate goal setting conversation.

Relationship between area-level socioeconomic status and health-related quality of life among cancer survivors.

Area-level socioeconomic status (SES) impacts cancer outcomes, such as stage at diagnosis, treatments received, and mortality. However, less is known about the relationship between area-level SES and health-related quality of life (HRQOL) for cancer survivors. To assess the additive value of area-level SES data and the relative contribution of area- and individual-level SES for estimating cancer survivors' HRQOL, we conducted a secondary analysis of data from a population-based survey study of cancer survivors (the Measuring Your Health [MY-Health] Study). Multilevel multinomial logistic regression models were used to examine the relationships between individual-level SES, area-level SES as measured by the Centers for Disease Control and Prevention's Social Vulnerability Index, and HRQOL group membership (high, average, low, or very low HRQOL). Area-level SES did not significantly increase model estimation accuracy compared to models using only individual-level SES. However, area-level SES could be an appropriate proxy when the individual-level SES is missing.

Did a bot eat your homework? An assessment of the potential impact of bad actors in online administration of preference surveys.

BACKGROUND: Online administration of surveys has a number of advantages but can also lead to increased exposure to bad actors (human and non-human bots) who can try to influence the study results or to benefit financially from the survey. We analyze data collected through an online discrete-choice experiment (DCE) survey to evaluate the likelihood that bad actors can affect the quality of the data collected. METHODS: We developed and fielded a survey instrument that included two sets of DCE questions asking respondents to select their preferred treatments for multiple myeloma therapies. The survey also included questions to assess respondents' attention while completing the survey and their understanding of the DCE questions. We used a latent-class model to identify a class associated with perverse preferences or high model variance, and the degree to which the quality checks included in the survey were correlated with class membership. Class-membership probabilities for the problematic class were used as weights in a random-parameters logit to recover population-level estimates that minimizes exposure to potential bad actors. RESULTS: Results show a significant proportion of respondents provided answers with a high degree of variability consistent with responses from bad actors. We also found that a wide-ranging selection of conditions in the survey screener is more consistent with choice patterns expected from bad actors looking to qualify for the study. The relationship between the number of incorrect answers to comprehension questions and problematic choice patterns peaked around 5 out of 10 questions. CONCLUSIONS: Our results highlight the need for a robust discussion around the appropriate way to handle bad actors in online preference surveys. While exclusion of survey respondents must be avoided under most circumstances, the impact of "bots" on preference estimates can be significant.

Designing and validating novel communication measures for pediatric, adolescent, and young adult oncology care and research: The PedCOM measures.

BACKGROUND: High-quality communication in pediatric and adolescent cancer is the standard of care. Yet, we lack pediatric-specific communication measures. We designed self-report and caregiver-report communication measures for use in pediatric oncology settings. METHODS: We recruited adolescent and young adults (AYAs; 12-24 years) with cancer and parents of children and AYAs between 1 month post-diagnosis and 2 months after completing treatment. Participants completed measures including 58 questions addressing eight previously characterized communication functions. For each function, we conducted factor analysis, and assessed reliability and construct validity. Based on psychometric properties, we created final long-form (31 items) and short-form (eight items) communication measures (PedCOM) for both self- and caregiver-report. RESULTS: Participants included 200 parents and 88 AYAs. The final 31-item and eight-item PedCOM measures for parents and AYAs demonstrated good unidimensional model fit. Each communication function (e.g., building relationships) demonstrated high reliability, coefficient alphas ranged from .83 to .93 for parents and .85 to .93 for AYAs. The overall 31-item and eight-item PedCOM measures also demonstrated high reliability (alphas >.9). For construct validity, PedCOM-Parent-31 and PedCOM-Parent-8 correlated positively with satisfaction with care, trust, emotional self-management, and decisional satisfaction, and negatively with anxiety and caregiver burden. PedCOM-AYA-31 and PedCOM-AYA-8 correlated positively with satisfaction with care, trust, emotional self-management, symptoms self-management, and decisional satisfaction, and negatively with anxiety. DISCUSSION: We developed valid and reliable measures of communication functions for parents and AYAs with cancer. These measures can support organizations and stakeholder groups that are striving to improve the quality of cancer care.

Real World Characterization of Chronic Pain, Success Rates and Implant Rates: Evidence from a Digital Health Platform of Patients Undergoing Spinal Cord Stimulation Evaluations.

Spinal cord stimulation is an effective treatment for those experiencing chronic back and leg pain but requires a temporary evaluation period (SCSeval) before permanent implantation. We present real-world data from 7,000 patients who underwent SCSeval while utilizing a mobile digital health platform for education, feedback, and outcomes collection during their surgical journey. We analyzed preoperative patient demographics, characterized patient pain profiles using the patient-reported outcomes measurement information system-29 surveys, and calculated the rates of conversion from temporary to permanent spinal cord stimulation (SCS) implantation. Between August 1, 2021, and March 2, 2023, 7,000 patients (mean age 59.1, 59.6% female) underwent SCSeval procedures while utilizing a mobile application. Patients commonly experienced aching, sharp, stabbing, tingling, numb, and burning pain. Patients had tried multiple prior therapies and wanted to reduce their use of opioids and pain medications. Overall, 90.1% of the patients had a successful SCSeval, and 80.4% of those converted to permanent implant, with the highest rates among those who underwent SCSeval in a hospital setting. There was a significant improvement in all domains of pain as evaluated by pre and postoperative patient-reported outcomes measurement information system-29 surveys. This study supports the use of digital health technology as part of the SCS journey to improve the patient experience and allow for robust patient-reported outcomes collection. The overall rate of SCSeval to permanent SCS in our study of 72.4% was higher than national rates of 64%, suggesting that an app may allow clinicians to better quantify changes in chronic pain and provide more insight into choosing to implant SCS permanently. PERSPECTIVE: This article presents real-world evidence from a digital health platform for therapy education and outcomes collection from patients undergoing spinal cord stimulation evaluation procedures. Such tools could allow for better pain characterization and allow for more nuanced tracking of patient outcomes among those with chronic pain.

Validation of the Observer-Reported Communication Ability (ORCA) measure for individuals with Rett syndrome.

PURPOSE: The study goal was to validate the Observer-Reported Communication Ability (ORCA) measure for use with females with Rett Syndrome (RTT). METHODS: Qualitative interviews, including concept elicitation and cognitive interviewing methods, were conducted with 19 caregivers of individuals with RTT ages 2 and older. A quantitative study was then conducted in 279 caregivers to evaluate construct validity and reliability. RESULTS: After minor modifications were made, the modified ORCA measure was well understood and captured key communication concepts. Quantitative data showed evidence for reliable scores (α = 0.90, test-retest intraclass correlation = 0.88), minimal floor and no ceiling effects, and strong correlation with the Communication and Symbolic Behaviors Scale (r = 0.73). CONCLUSIONS: This study provided initial support that the modified ORCA measure is an acceptable caregiver-reported measure of communication ability for females with RTT. Future work should include evaluation of longitudinal validity of the measure and its associations with clinician- and performance-based measures in diverse samples.

More Than a Headache: Lived Experience of Migraine in Youth.

BACKGROUND: Migraine is the leading cause of disability among adolescents and young adults. We aimed to characterize the impact of migraine on the experience of children, adolescents, and caregivers. METHODS: This descriptive qualitative study recruited youth aged four to 18 years with migraine and their caregivers from the multicenter, prospective Pediatric Migraine Registry between 2020 and 2021. Participants completed semistructured interviews targeting the lived experience of migraine. A conventional content analysis approach was used to analyze data. RESULTS: Thirty enrolled dyads (n = 30 children and adolescents, n = 29 caregivers) completed 59 interviews (n = 29 child and adolescent interviews, n = 30 caregiver interviews). Children and adolescents had a median age of 15 years and experienced a median of 13.5 headache days per month. Caregivers had a median age of 44 years and predominantly identified as mothers (n = 28). We identified three themes: (1) Impact on emotional well-being: participants described how their migraine experience included feelings of isolation, depression, and irritability alongside the need for social support; (2) Impact on daily life: participants described how symptoms and unpredictability impacted their ability to perform activities of daily living; and (3) Impact on school: participants described how migraine impacted their school experience, including threatened attendance and worsened performance. CONCLUSIONS: In this cohort of youth and their caregivers, we identified salient themes to characterize the experience of migraine. Our findings underscore the urgent need for effective migraine treatments and interventions targeting co-occurring mental health conditions, peer relationships, and school support.

Swahili translation and cultural adaptation of the pediatric patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

BACKGROUND: The pediatric patient-reported outcomes version of the common terminology criteria for adverse event measure was developed and validated for use in pediatric cancer clinical trials to better capture the symptom experiences through direct self-report. The study aim was to develop and validate a Swahili language version of the patient-reported outcomes version of the common terminology criteria for adverse event measure. METHODS: The pediatric version of 15 core symptom adverse events, and the corresponding questions, were selected from the patient-reported outcomes version of the common terminology criteria for adverse event library, then forward and back translated into Swahili by bilingual translators. The translated items were further refined using concurrent cognitive interviewing. Each round of interviews included five children, ages 8-17 years-old, receiving cancer therapy at Bugando Medical Centre, the cancer referral hospital for Northwest Tanzania, and continued until at least 80% of participants understood the question. RESULTS: Three rounds of cognitive interviews were completed involving 13 patients and 5 caregivers. Among patients, 50% of questions (19/38) were fully comprehended after the first interview round. Two Adverse Events (anxiety and peripheral neuropathy) were the most difficult for participants to understand, associated with education level and experience. Goal comprehension was achieved after three rounds of interviews with no further revisions required. All parents in the first cognitive interview group comprehended the survey, with no additional revisions. CONCLUSION: A Swahili patient-reported outcomes version of the common terminology criteria for adverse event was effective in eliciting patient-reported Adverse Events related to cancer treatment, with good comprehension for children aged 8-17 years. This survey is important to incorporate patient self-reporting of symptomatic toxicities and is an effective tool to increase capacity for pediatric cancer clinical trials throughout East Africa, further reducing global disparities in cancer care.

Health-related quality of life profiles in adolescents and young adults with chronic conditions.

PURPOSE: To assess health-related quality of life (HRQOL) among adolescents and young adults (AYAs) with chronic conditions. METHODS: AYAs (N = 872) aged 14-20 years completed NIH's Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures of physical function, pain interference, fatigue, social health, depression, anxiety, and anger. Latent profile analysis (LPA) was used to group AYAs into HRQOL profiles using PROMIS T-scores. The optimal number of profiles was determined by model fit statistics, likelihood ratio test, and entropy. Multinomial logistic regression models were used to examine how LPA's HRQOL profile membership was associated with patient demographic and chronic conditions. The model prediction accuracy on profile membership was evaluated using Huberty's I index with a threshold of 0.35 for good effect. RESULTS: A 4-profile LPA model was selected. A total of 161 (18.5%), 256 (29.4%), 364 (41.7%), and 91 (10.4%) AYAs were classified into Minimal, Mild, Moderate, and Severe HRQOL Impact profiles. AYAs in each profile had distinctive mean scores with over a half standard deviation (5-points in PROMIS T-scores) of difference between profiles across most HRQOL domains. AYAs who were female or had conditions such as mental health condition, hypertension, and self-reported chronic pain were more likely to be in the Severe HRQOL Impact profile. The Huberty's I index was 0.36. CONCLUSIONS: Approximately half of AYAs with a chronic condition experience moderate to severe HRQOL impact. The availability of risk prediction models for HRQOL impact will help to identify AYAs who are in greatest need of closer clinical care follow-up.

Association of Patient-Reported Health-Related Quality of Life With Physician-Reported Toxicities in Adolescents and Young Adults Receiving Radiation Therapy for Cancer.

PURPOSE: Radiation therapy (RT) may cause toxicities in adolescents and young adults (AYAs, age 15-39 years) with cancer. However, the range of RT-related toxicities in AYAs and the affect on health-related quality of life (HRQOL) has not been well studied. We performed a cross-sectional study in AYAs with cancer who received RT to identify RT-related toxicities and examine their impact on HRQOL. MATERIALS AND METHODS: A total of 178 AYAs received RT and completed PROMIS HRQOL instruments from 2018 to 2022. Acute and late physician-graded Common Terminology Criteria for Adverse Events RT-related toxicities were extracted and described. Multivariable linear regression was used to evaluate the association of RT-related toxicity with HRQOL scores during and post-RT. Minimally important differences were used to evaluate the clinical relevance of relationships. RESULTS: Eighty-four AYAs completed HRQOL surveys during RT and 94 post-RT. In the during-RT cohort, 75 AYAs (89%) had acute RT-related toxicities, a majority of which were grade 1 (n = 49, 65%). AYAs who experienced acute grade 2 or greater toxicities reported worse global mental health (B = -7.35, P < .01) and worse pain (B = 5.25, P = .01) than those with acute grade 1 or no toxicities. In the post-RT cohort, the median (IQR) time from RT to survey completion was 24 (14-27) months. Forty-eight AYAs (51%) had late RT-related toxicities, a majority of which were grade 1 (n = 37, 77%). AYAs who experienced late grade 2 or greater toxicities reported worse global mental health (B = -8.07, P = .01), worse social roles (B = -9.96, P < .01), and greater sleep disturbance (B = 10.75, P < .01) than those with late grade 1 or no RT toxicities. CONCLUSION: The presence of acute and late grade 2 or greater RT-related toxicities may contribute to worse HRQOL, especially global mental health, in AYAs. Screening and early interventions to mitigate RT-related toxicities are needed to improve AYA HRQOL.

Patient-Reported Outcomes in Pediatric Patients With Cancer.

Patient-reported outcomes (PROs) are reported directly by the patients about their own health. The objective of this article was to provide an overview of PROs in pediatric cancer, to describe how PROs can be incorporated into pediatric cancer clinical trials, and to discuss how PROs can guide symptom management treatment choices in pediatric oncology. Pediatric patient self-report provides a distinct voice in describing their experience compared with family caregiver or clinician report. Thus, every effort should be made to allow children to self-report symptoms, functioning, and other quality-of-life impacts and to use that data to inform treatment decision making. In addition to its incorporation into routine clinical care, it is also important to incorporate PROs into clinical trials to understand the patient experience of treatment toxicities and their impact on quality of life. Key considerations include clearly articulated PRO aims, selection of outcomes, choice of PRO measures, and frequency of PRO assessments. Once PROs are integrated into routine clinical care, it will be important to enable evidence-based symptom management. Strategies should be based on clinical practice guidelines (CPGs). Development and adaptation of care pathways on the basis of CPGs is one approach to standardize evidence-based symptom management at individual institutions. PROs are important to pediatric patients with cancer and their families. Self-report should be emphasized wherever possible. Approaches to enable PRO reporting into routine clinical care and enable preventative and therapeutic actions for symptom management are important. These efforts will optimize quality of life for pediatric patients with cancer.