Definitions of disease burden across the spectrum of metastatic castration-sensitive prostate cancer: comparison by disease outcomes and genomics.

BACKGROUND: Several definitions have attempted to stratify metastatic castrate-sensitive prostate cancer (mCSPC) into low and high-volume states. However, at this time, comparison of these definitions is limited. Here we aim to compare definitions of metastatic volume in mCSPC with respect to clinical outcomes and mutational profiles. METHODS: We performed a retrospective review of patients with biochemically recurrent or mCSPC whose tumors underwent somatic targeted sequencing. 294 patients were included with median follow-up of 58.3 months. Patients were classified into low and high-volume disease per CHAARTED, STAMPEDE, and two numeric (≤3 and ≤5) definitions. Endpoints including radiographic progression-free survival (rPFS), time to development of castration resistance (tdCRPC), and overall survival (OS) were evaluated with Kaplan-Meier survival curves and log-rank test. The incidence of driver mutations between definitions were compared. RESULTS: Median OS and tdCRPC were shorter for high-volume than low-volume disease for all four definitions. In the majority of patients (84.7%) metastatic volume classification did not change across all four definitions. High volume disease was significantly associated with worse OS for all four definitions (CHAARTED: HR 2.89; p < 0.01, STAMPEDE: HR 3.82; p < 0.01, numeric ≤3: HR 4.67; p < 0.01, numeric ≤5: HR 3.76; p < 0.01) however, were similar for high (p = 0.95) and low volume (p = 0.79) disease across all four definitions. Those with discordant classification tended to have more aggressive clinical behavior and mutational profiles. Patients with low-volume disease and TP53 mutation experienced a more aggressive course with rPFS more closely mirroring high-volume disease. CONCLUSIONS: The spectrum of mCSPC was confirmed across four different metastatic definitions for clinical endpoints and genetics. All definitions were generally similar in classification of patients, outcomes, and genetic makeup. Given these findings, the simplicity of numerical definitions might be preferred, especially when integrating metastasis directed therapy. Incorporation of tumor genetics may allow further refinement of current metastatic definitions.

Combined Longitudinal Clinical and Autopsy Phenomic Assessment in Lethal Metastatic Prostate Cancer: Recommendations for Advancing Precision Medicine.

BACKGROUND: Systematic identification of data essential for outcome prediction in metastatic prostate cancer (mPC) would accelerate development of precision oncology. OBJECTIVE: To identify novel phenotypes and features associated with mPC outcome, and to identify biomarker and data requirements to be tested in future precision oncology trials. DESIGN SETTING AND PARTICIPANTS: We analyzed deep longitudinal clinical, neuroendocrine expression, and autopsy data of 33 men who died from mPC between 1995 and 2004 (PELICAN33), and related findings to mPC biomarkers reported in the literature. INTERVENTION: Thirty-three men prospectively consented to participate in an integrated clinical-molecular rapid autopsy study of mPC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Data exploration with correction for multiple testing and survival analysis from the time of diagnosis to time to death and time to first occurrence of severe pain as outcomes were carried out. The effect of seven complications on the modeled probability of dying within 2 yr after presenting with the complication was evaluated using logistic regression. RESULTS AND LIMITATIONS: Feature exploration revealed novel phenotypes related to mPC outcome. Four complications (pleural effusion, severe anemia, severe or controlled pain, and bone fracture) predict the likelihood of death within 2 yr. Men with Gleason grade group 5 cancers developed severe pain sooner than those with lower-grade tumors. Surprisingly, neuroendocrine (NE) differentiation was frequently observed in the setting of high serum prostate-specific antigen (PSA) levels (≥30 ng/ml). In 4/33 patients, no controlled (requiring analgesics) or severe pain was detected, and strikingly, 14/15 metastatic sites studied in these men did not express NE markers, suggesting an inverse relationship between NE differentiation and pain in mPC. Intracranial subdural metastasis is common (36%) and is usually clinically undetected. Categorization of "skeletal-related events" complications used in recent studies likely obscures the understanding of spinal cord compression and fracture. Early death from prostate cancer was identified in a subgroup of men with a low longitudinal PSA bandwidth. Cachexia is common (body mass index <0.89 in 24/31 patients) but limited to the last year of life. Biomarker review identified 30 categories of mPC biomarkers in need of winnowing in future trials. All findings require validation in larger cohorts, preferably alongside data from this study. CONCLUSIONS: The study identified novel outcome subgroups for future validation and provides "vision for mPC precision oncology 2020-2050" draft recommendations for future data collection and biomarker studies. PATIENT SUMMARY: To better understand variation in metastatic prostate cancer behavior, we assembled and analyzed longitudinal clinical and autopsy records in 33 men. We identified novel outcomes, phenotypes, and aspects of disease burden to be tested and refined in future trials.

Problem Solving to Enhance Clinical Trial Participation Utilizing a Framework-Driven Approach.

Health professionals agree that increasing diversity in clinical trial participants is an important way to improve cancer care and address disparities in outcomes. However, trial participation among minority populations has been low historically and continues to be low. Underrepresentation has resulted in majority groups reaping greater benefit from research findings, thus widening cancer health disparities. Addressing these disparities effectively has proven to be challenging. To maximize diversity among participants, it is necessary to understand the steps patients take to enroll in trials; the barriers patients face at each step; and the needs and preferences of the patient population overall and subgroups specified by age, race, ethnicity, or sex, in order to develop interventions to address barriers to participation. To improve clinical trial participation, and most importantly to eliminate disparities, cancer centers should examine reasons patients fail to enroll in trials and develop interventions designed to meet their patients' needs and preferences.

Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Prostate cancer commonly metastasizes to bone, and bone metastases are associated with pathologic fractures, pain, and reduced survival. Bone disease is routinely visualized using the technetium Tc 99m (99mTc) bone scan; however, the standard interpretation of bone scan data relies on subjective manual assessment of counting metastatic lesion numbers. There is an unmet need for an objective and fully quantitative assessment of bone scan data. Objective: To clinically assess in a prospectively defined analysis plan of a clinical trial the automated Bone Scan Index (aBSI) as an independent prognostic determinant of overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC). Design, Setting, and Participants: This investigation was a prospectively planned analysis of the aBSI in a phase 3 multicenter randomized, double-blind, placebo-controlled clinical trial of tasquinimod (10TASQ10). Men with bone metastatic chemotherapy-naïve CRPC were recruited at 241 sites in 37 countries between March 2011 and August 2015. The statistical analysis plan to clinically evaluate the aBSI was prospectively defined and locked before unmasking of the 10TASQ10 study. The analysis of aBSI was conducted between May 25, 2016, and June 3, 2017. Main Outcomes and Measures: The associations of baseline aBSI with OS, radiographic progression-free survival (rPFS), time to symptomatic progression, and time to opiate use for cancer pain. Results: Of the total 1245 men enrolled, 721 were evaluable for the aBSI. The mean (SD) age (available for 719 men) was 70.6 (8.0) years (age range, 47-90 years). The aBSI population was representative of the total study population based on baseline characteristics. The aBSI (median, 1.07; range, 0-32.60) was significantly associated with OS (hazard ratio [HR], 1.20; 95% CI, 1.14-1.26; P < .001). The median OS by aBSI quartile (lowest to highest) was 34.7, 27.3, 21.7, and 13.3 months, respectively. The discriminative ability of the aBSI (C index, 0.63) in prognosticating OS was significantly higher than that of the manual lesion counting (C index, 0.60) (P = .03). In a multivariable survival model, a higher aBSI remained independently associated with OS (HR, 1.06; 95% CI, 1.01-1.11; P = .03). A higher aBSI was also independently associated with time to symptomatic progression (HR, 1.18; 95% CI, 1.13-1.23; P < .001) and time to opiate use for cancer pain (HR, 1.21; 95% CI, 1.14-1.30; P < .001). Conclusions and Relevance: To date, this investigation is the largest prospectively analyzed study to validate the aBSI as an independent prognostic imaging biomarker of survival in mCRPC. These data support the prognostic utility of the aBSI as an objective imaging biomarker in the design and eligibility of clinical trials of systemic therapies for patients with mCRPC. Trial Registration: ClinicalTrials.gov Identifier: NCT01234311.

Relationship Between Quality of Comorbid Condition Care and Costs for Cancer Survivors.

PURPOSE: To estimate the association between cancer survivors' comorbid condition care quality and costs; to determine whether the association differs between cancer survivors and other patients. METHODS: Using the SEER-Medicare-linked database, we identified survivors of breast, prostate, and colorectal cancers who were diagnosed in 2004, enrolled in Medicare fee-for-service for at least 12 months before diagnosis, and survived ≥ 3 years. Quality of care was assessed using nine process indicators for chronic conditions, and a composite indicator representing seven avoidable outcomes. Total costs on the basis of Medicare amount paid were grouped as inpatient and outpatient. We examined the association between care quality and costs for cancer survivors, and compared this association among 2:1 frequency-matched noncancer controls, using comparisons of means and generalized linear regressions. RESULTS: Our sample included 8,661 cancer survivors and 17,332 matched noncancer controls. Receipt of recommended care was associated with higher outpatient costs for eight indicators, and higher inpatient and total costs for five indicators. For three measures (visit every 6 months for patients with chronic obstructive pulmonary disease or diabetes, and glycosylated hemoglobin or fructosamine every 6 months for patients with diabetes), costs for cancer survivors who received recommended care increased less than for noncancer controls. The absence of avoidable events was associated with lower costs of each type. An annual eye examination for patients with diabetes was associated with lower inpatient costs. CONCLUSION: Higher-quality processes of care may not reduce short-term costs, but the prevention of avoidable outcomes reduces costs. The association between quality and cost was similar for cancer survivors and noncancer controls.

Identifying changes in scores on the EORTC-QLQ-C30 representing a change in patients' supportive care needs.

PURPOSE: Using health-related quality-of-life measures for patient management requires knowing what changes in scores require clinical attention. We estimated changes on the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC-QLQ-C30), representing important changes by comparing to patient-reported changes in supportive care needs. METHODS: This secondary analysis used data from 193 newly diagnosed cancer patients (63 % breast, 37 % colorectal; mean age 60 years; 20 % male) from 28 Canadian surgical practices. Participants completed the Supportive Care Needs Survey-Short Form-34 (SCNS-SF34) and EORTC-QLQ-C30 at baseline, 3, and 8 weeks. We calculated mean changes in EORTC-QLQ-C30 scores associated with improvement, worsening, and no change in supportive care needs based on the SCNS-SF34. Mean changes in the EORTC-QLQ-C30 scores associated with the SCNS-SF34 improved and worsened categories were used to estimate clinically important changes, and the 'no change' category to estimate insignificant changes. RESULTS: EORTC-QLQ-C30 score changes ranged from 6 to 32 points for patients reporting improved supportive care needs; statistically significant changes were 10-32 points. EORTC-QLQ-C30 score changes ranged from 21-point worsening to 21-point improvement for patients reporting worsening supportive care needs; statistically significant changes were 9-21 points in the hypothesized direction and a 21-point statistically significant change in the opposite direction. EORTC-QLQ-C30 score changes ranged from a 1-point worsening to 16-point improvement for patients reporting stable supportive care needs. CONCLUSION: These data suggest 10-point EORTC-QLQ-C30 score changes represent changes in supportive care needs. When using the EORTC-QLQ-C30 in clinical practice, scores changing ≥10 points should be highlighted for clinical attention.

Assessment of the bone scan index in a randomized placebo-controlled trial of tasquinimod in men with metastatic castration-resistant prostate cancer (mCRPC).

INTRODUCTION: Drug development and clinical decision making for patients with metastatic prostate cancer (PC) have been hindered by a lack of quantitative methods of assessing changes in bony disease burden that are associated with overall survival (OS). Bone scan index (BSI), a quantitative imaging biomarker of bone tumor burden, is prognostic in men with metastatic PC. We evaluated an automated method for BSI calculation for the association between BSI over time with clinical outcomes in a randomized double-blind trial of tasquinimod (TASQ) in men with metastatic castration-resistant PC (mCRPC). METHODS: Bone scans collected during central review from the TASQ trial were analyzed retrospectively using EXINIbone(BSI), an automated software package for BSI calculation. Associations between BSI and other prognostic biomarkers, progression-free survival, OS, and treatment were evaluated over time. RESULTS: Of 201 men (57 TASQ and 28 placebo), 85 contributed scans at baseline and week 12 of sufficient quality. Baseline BSI correlated with prostate-specific antigen and alkaline phosphatase levels and was associated with OS in univariate (hazard ratio [HR] = 1.42, P = 0.013) and multivariate (HR = 1.64, P<0.001) analyses. BSI worsening at 12 weeks was prognostic for progression-free survival (HR = 2.14 per BSI doubling, P<0.001) and OS (HR = 1.58, P = 0.033) in multivariate analyses including baseline BSI and TASQ treatment. TASQ delayed BSI progression. CONCLUSIONS: BSI and BSI changes over time were independently associated with OS in men with mCRPC. A delay in objective radiographic bone scan progression with TASQ is suggested; prospective evaluation of BSI progression and response criteria in phase 3 trials of men with mCRPC is warranted.

It's who you know: patient-sharing, quality, and costs of cancer survivorship care.

PURPOSE: Cancer survivors frequently receive care from a large number of physicians, creating challenges for coordination. We sought to explore whether cancer survivors whose providers have more patients in common (e.g., shared patients) tend to have higher quality and lower cost care. METHODS: We performed a retrospective cohort study of 8,661 patients diagnosed with loco-regional breast, prostate, or colorectal cancer. We examined survivorship care from days 366 to 1,095 following their cancer diagnosis. Our primary independent variable was "care density," a novel metric of the extent to which a patient's providers share patients with one another. Our outcome measures were health care utilization, quality metrics, and costs. RESULTS: In adjusted analyses, we found that patients with high care density--indicating high levels of patient-sharing among their providers--had significantly lower rates of hospitalization (OR 0.87, 95% CI 0.75-1.00) and higher odds of an eye examination for diabetes (OR 1.31, 95% CI 1.03-1.66) compared to patients with low care density. High care density was not associated with emergency department visits, avoidable outcomes, lipid profile following an angina diagnosis, or odds of glycosylated hemoglobin testing for diabetes. Patients with high care density had significantly lower total costs of care over 24 months (beta coefficient -$2,116, 95% CI -$3,107 to -$1,125) along with lower inpatient and outpatient costs. CONCLUSION: Cancer survivors treated by physicians who share more patients with one another tend to have some higher aspects of quality and lower cost care. IMPLICATIONS OF CANCER SURVIVORS: If validated, care density may be a useful indicator for monitoring care coordination among cancer survivors and potentially targeting interventions that seek to improve care delivery.

Feasibility and value of PatientViewpoint: a web system for patient-reported outcomes assessment in clinical practice.

BACKGROUND: The PatientViewpoint website collects patient-reported outcomes and links them with the electronic health record to aid patient management. This pilot test evaluated PatientViewpoint's use, usefulness, and acceptability to patients and clinicians. METHODS: This was a single-arm prospective study that enrolled breast and prostate cancer patients undergoing treatment and the clinicians who managed them. Patients completed patient-reported outcomes every 2 weeks, and clinicians could access the results for patient visits. Scores that were poor relative to norms or substantially worse than the previous assessment were highlighted. After three on-study visits, we assessed patient and clinician perspectives on PatientViewpoint using close-ended and open-ended questions. RESULTS: Eleven out of 12 eligible clinicians (92%) and 52/76 eligible patients (68%) enrolled. Patients completed a median of 71% of assigned questionnaires; clinicians reported using the information for 79% of patients, most commonly as a source of additional information (51%). At the median, score reports identified three potential issues, of which 1 was discussed during the visit. Patients reported the system was easy to use (92%), useful (70%), aided recall of symptoms/side effects (72%), helped them feel more in control of their care (60%), improved discussions with their provider (49%), and improved care quality (39%). Patients and clinicians desired more information on score interpretation and minor adjustments to site navigation. CONCLUSIONS: These results support the feasibility and value of PatientViewpoint. An ongoing study is using a continuous quality improvement approach to further refine PatientViewpoint. Future studies will evaluate its impact on patient care and outcomes.

Removing barriers to participation in clinical trials, a conceptual framework and retrospective chart review study.

BACKGROUND: Enrollment in interventional therapeutic clinical trials is a small fraction of all patients who might participate given reasonable access. METHODS: A hierarchical approach is utilized in measuring staged participation from trial availability to patient enrollment. Our framework suggests that concern for justice comes in the design and eligibility criteria for clinical trials; attention to beneficence is given in the eligibility and physician triage stages. The remaining four stages rely on respect for persons. An example is given where reasons for nonparticipation or barriers to participation in prostate cancer clinical trials are examined within the framework. In addition, medical oncology patients with an initial six month consultation are tracked from one stage to the next by race using the framework to assess participation comparability. RESULTS: We illustrated seven transitions from being a patient to enrollment in a clinical trial in a small study of prostate cancer cases who consulted SKCCC Medical Oncology Department in early 2010. Pilot data suggest transition probabilities as follows: 65% availability, 84% eligibility, 92% patient triage, 89% trials discussed, 45% patient interested, 63% patient consented, and 92% patient enrolled. The average transition probability was 77.7%. The average transition probability, patient-trial-fit was 50%; opportunity was 51%, and acceptance was 66.7%. Trial availability, patient interest and patient consented were three transitions that were below the average; none were statistically significant. CONCLUSIONS: The framework may serve to streamline comprehensive reporting of clinical trial participation to the benefit of patients and the ethical conduct of clinical trials.

How does initial treatment choice affect short-term and long-term costs for clinically localized prostate cancer?

BACKGROUND: Data regarding costs of prostate cancer treatment are scarce. This study investigates how initial treatment choice affects short-term and long-term costs. METHODS: This retrospective, longitudinal cohort study followed prostate-cancer cases diagnosed in 2000 for 5 years using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Men age≥66 years, in Medicare fee for service, diagnosed with clinically localized prostate cancer in 2000 while residing in a SEER region, were matched to noncancer controls using age, sex, race, region, comorbidity, and survival. On the basis of treatment received during the first 9 months postdiagnosis, patients were assigned to watchful waiting, radiation, hormonal therapy, hormonal+radiation, and surgery (may have received other treatments). Incremental costs for prostate cancer were the difference in costs for prostate cancer cases versus matched controls. Costs were divided into initial treatment (months -1 to 12), long-term (each 12 months thereafter), and total (months -1 to 60). Sensitivity analyses excluded the last 12 months of life. RESULTS: A total of 13,769 prostate-cancer cases were matched to 13,769 noncancer controls. Watchful waiting had the lowest initial treatment ($4270) and 5-year total costs ($9130). Initial treatment costs were highest for hormonal+radiation ($17,474) and surgery ($15,197). At $26,896, 5-year total costs were highest for hormonal therapy only followed by hormonal+radiation ($25,097) and surgery ($19,214). After excluding the last 12 months of life, total costs were highest for hormonal+radiation ($23,488) and hormonal therapy ($23,199). CONCLUSIONS: Patterns of costs vary widely based on initial treatment. These data can inform patients and clinicians considering treatment options and policy makers interested in patterns of costs.

Needs assessments can identify scores on HRQOL questionnaires that represent problems for patients: an illustration with the Supportive Care Needs Survey and the QLQ-C30.

PURPOSE: A barrier to using HRQOL questionnaires for individual patient management is knowing what score represents a problem deserving attention. We explored using needs assessments to identify HRQOL scores associated with patient-reported unmet needs. METHODS: This cross-sectional study included 117 cancer patients (mean age 61 years; 51% men; 77% white) who completed the Supportive Care Needs Survey (SCNS) and EORTC QLQ-C30. SCNS scores were dichotomized as "no unmet need" versus "some unmet need" and served as an external criterion for identifying problem scores. We evaluated the discriminative ability of QLQ-C30 scores using receiver operating characteristic (ROC) analysis. Domains with an area under the ROC curve (AUC) >or= .70 were examined further to determine how well QLQ-C30 scores predicted presence/absence of unmet need. RESULTS: We found AUCs >or= .70 for 6 of 14 EORTC domains: physical, emotional, role, global QOL, pain, fatigue. All 6 domains had sensitivity >or= .85 and specificity >or= .50. EORTC domains that closely matched the content of SCNS item(s) were more likely to have AUCs >or= .70. The appropriate cut-off depends on the relative importance of false positives and false negatives. CONCLUSIONS: Needs assessments can identify HRQOL scores requiring clinicians' attention. Future research should confirm these findings using other HRQOL questionnaires and needs assessments.

Concordance of cancer patients' function, symptoms, and supportive care needs.

PURPOSE: Although patients' function, symptoms, and supportive care needs are obviously related, a better understanding of these relationships could improve patient management. METHODS: In this cross-sectional, observational study, 117 cancer patients completed the Supportive Care Needs Survey-34 and EORTC-QLQ-C30. Each symptom and function domain from the EORTC-QLQ-C30 was dichotomized (high vs. low) using a cut-off of reference sample mean scores. Each need domain was dichotomized using a cut-off of an average score representing an unmet need. We explored within-patient patterns of function, symptom, and need domains using latent class analysis. Based on these patterns, patients were categorized as high versus low function; high versus low symptom; and high versus low need. We examined the concordance between categorizations of patients' function, symptoms, and needs. RESULTS: The categorizations of function, symptoms, and needs were concordant for 66 patients (56%). Among patients with deficits in at least one area (n = 68), categorizations for 51 patients (75%) were discordant. CONCLUSIONS: About 50% of patients have similar classifications of their level of function, symptoms, and needs, but discordance was common among patients with deficits in at least one area, emphasizing the importance of assessing all of these outcomes as part of patient evaluations.

Department of Defense prostate cancer clinical trials consortium: a new instrument for prostate cancer clinical research.

BACKGROUND: In 2005, the US Department of Defense, through the US Army Medical Research and Materiel Command, Office of the Congressionally Directed Medical Research Programs, created a funding mechanism to form a clinical trials consortium to conduct phase I and II studies in prostate cancer. This is the first report of the Prostate Cancer Clinical Trials Consortium (PCCTC). PATIENTS AND METHODS: The Department of Defense award supports a consortium of 10 prostate cancer research centers. Memorial Sloan-Kettering Cancer Center was awarded the Coordinating Center grant for the consortium and charged with creating an infrastructure to conduct early-phase multicenter clinical trials. Each participating center was required to introduce >or=1 clinical trial per year and maintain accrual of a minimum of 35 patients per year. RESULTS: The PCCTC was launched in 2006 and now encompasses 10 leading prostate cancer research centers. Fifty-one trials have been opened, and 1386 patients have been accrued at member sites. Members share an online clinical trial management system for protocol tracking, electronic data capture, and data storage. A legal framework has been instituted, and standard operating procedures, an administrative structure, editorial support, centralized budgeting, and mechanisms for scientific review are established. CONCLUSION: The PCCTC fulfills a congressional directive to create a clinical trials instrument dedicated to early-phase prostate cancer studies. The member institutions have built an administrative, informatics, legal, financial, statistical, and scientific infrastructure to support this endeavor. Clinical trials are open and accruing in excess of federally mandated goals.

Symptoms, supportive care needs, and function in cancer patients: how are they related?

AIMS: To explore the associations among symptoms, supportive care needs, and function. METHODS: One hundred and seventeen cancer patients completed the Supportive Care Needs Survey and EORTC-QLQ-C30 in a cross-sectional study. Associations among function (physical, role, emotional, cognitive, social), symptoms (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea), and supportive care needs (physical and daily living, psychological, patient care and support, health system and information, sexual) were tested using multivariate item regression (MIR). We tested (1) function as the dependent variable with symptoms and supportive care needs as independent variables and (2) supportive care needs as the dependent variable with symptoms and function as independent variables. RESULTS: Worse fatigue, pain, and appetite loss were associated with worse function. Greater unmet physical and daily living needs were associated with worse physical, role, and cognitive function. Greater unmet psychological needs were associated with worse emotional and cognitive function. Worse sleep problems were associated with greater unmet needs. Better physical function was associated with fewer unmet physical and daily living needs, and better emotional function was associated with fewer unmet psychological, patient care and support, and health system and information needs. CONCLUSIONS: The results obtained with these models suggest several consistent relationships among symptoms, supportive care needs, and function.

Asking the right questions: investigating needs assessments and health-related quality-of-life questionnaires for use in oncology clinical practice.

GOALS OF WORK: Questionnaires used in oncology practice for individual patient management need to address issues patients find important and want help with and issues cancer center health professionals can address. We investigated the item content from two health-related quality-of-life (HRQOL) questionnaires and two needs assessments for this purpose. PATIENTS AND METHODS: In this preliminary study, 61 cancer patients and 19 cancer center health professionals rated the item content from the EORTC-QLQ-C30, FACT-G, Supportive Care Needs Survey-34 (SCNS), and Kingston Needs Assessment--Cancer. Patients rated each item's importance and whether they wanted help with it; health professionals rated each item's importance and whether they felt able to help patients address it. Patients and health professionals also reported their overall questionnaire preference. MAIN RESULTS: Patients rated information about treatments (options, benefits, side effects) and care coordination as the most important issues and those for which they most wanted help from their health professionals. Health professionals rated pain and other symptom/side effect items as most important to patients and those for which they were most able to help. Findings were consistent across tumor type and treatment status. Patients had an overall preference for the SCNS. Health professionals had no clear questionnaire preference. CONCLUSIONS: This preliminary study suggests that the issues patients most want help with may not be the issues that health professionals feel most able to address. If these findings are confirmed in more representative samples, interventions may be needed to assist health professionals in managing cancer patients' HRQOL issues and needs.