Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial.

PURPOSE: Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). METHODS AND MATERIALS: The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). RESULTS: Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction - General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. CONCLUSIONS: For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

Families' perceptions of veterans' distress due to post-traumatic stress disorder-related symptoms at the end of life.

OBJECTIVES: To define the frequency of post-traumatic stress disorder (PTSD)-related symptoms among veterans who are near the end of life and to describe the impact that these symptoms have on patients and their families. METHODS: Patients had received inpatient or outpatient care from a participating VA facility in the last month of life, and one family member per patient was selected using predefined eligibility criteria. Family members then completed a telephone survey, The Family Assessment of Treatment at End-of-Life, which assessed their perceptions of the quality of the care that the patients and they themselves received during the patients' last month of life. RESULTS: Seventeen percent of patients (89 of 524) were reported to have had PTSD-related symptoms in the last month of life. PTSD-related symptoms caused discomfort less often than pain did (mean frequency score 1.79 vs. 1.93; Wilcoxon sign rank test, P<0.001) but more often than dyspnea did (mean severity score 1.79 vs. 1.73; Wilcoxon sign rank test, P<0.001). Family members of patients with PTSD-related symptoms reported less satisfaction overall with the care the patient received (mean score 48 vs. 62; rank sum test, P<0.001). Patients who received a palliative care consult (n=49) had lower ratings of discomfort attributed to PTSD-related symptoms (mean 1.55 vs. 2.07; rank sum test, P=0.007). CONCLUSION: PTSD-related symptoms may be common and severe among veterans near the end of life and may have a negative effect on families' perceptions of the quality of care that the veteran received.

Race, treatment preferences, and hospice enrollment: eligibility criteria may exclude patients with the greatest needs for care.

BACKGROUND: The requirement that patients give up curative treatment makes hospice enrollment unappealing for some patients and may particularly limit use among African-American patients. The current study was conducted to determine whether African-American patients with cancer are more likely than white patients to have preferences for cancer treatment that exclude them from hospice and whether they are less likely to want specific hospice services. METHODS: Two hundred eighty-three patients who were receiving treatment for cancer at 6 oncology clinics within the University of Pennsylvania Cancer Network completed conjoint interviews measuring their perceived need for 5 hospice services and their preferences for continuing cancer treatment. Patients were followed for 6 months or until death. RESULTS: African-American patients had stronger preferences for continuing their cancer treatments on a 7-point scale even after adjusting for age, sex, finances, education, Eastern Cooperative Oncology Group performance status, quality of life, and physical and psychologic symptom burden (adjusted mean score, 4.75 vs 3.96; beta coefficient, 0.82; 95% confidence interval, 0.22-1.41 [P = .007]). African-American patients also had greater perceived needs for hospice services after adjusting for these characteristics (adjusted mean score, 2.31 vs 1.83; beta coefficient, 0.51; 95% confidence interval, 0.11-0.92 [P = .01]). However, this effect disappeared after adjusting for household finances. CONCLUSIONS: Hospice eligibility criteria may exclude African-American patients disproportionately despite greater perceived needs for hospice services in this population. The mechanisms driving this health disparity likely include both cultural differences and economic characteristics, and consideration should be given to redesigning hospice eligibility criteria.

Do phase 1 patients have greater needs for palliative care compared with other cancer patients?

BACKGROUND: Phase 1 oncology trial participants often are excluded from hospice. However, it is not known whether they would benefit from hospice services. The objectives of the current study were to define the palliative care needs of these patients and to determine whether their needs are greater than those of other cancer patients. METHODS: Two hundred ninety-seven patients who were undergoing cancer therapy and 69 patients who were enrolled in phase 1 trials at 7 oncology clinics in an urban cancer network were recruited and consented to participate in interviews. Interviewers assessed the prevalence and severity of 10 symptoms using the Global Distress Index of the Memorial Symptom Assessment Scale and patients' perceived need for 4 services typically provided through hospice: a chaplain, counselor, home health aide, and visiting nurse. RESULTS: Patients in the 2 groups had a similar symptom burden. However, after adjusting for Eastern Cooperative Oncology Group performance status scores, phase 1 patients were more likely to have 5 of the 10 symptoms and reported greater severity for 6 of the 10 symptoms. Compared with other patients, phase 1 patients were less likely to say they needed a home health aide (4 of 69 patients [6%] vs 198 of 297 patients [67%]), a chaplain (7 of 69 patients [10%] vs 134 of 297 patients [45%]), or a counselor (11 of 69 patients [16%] vs 160 of 297 patients [54%]; chi-square test: P<.001 for all). They were equally likely to say they needed a visiting nurse (30 of 69 patients [44%] vs 142 of 297 patients [48%]; chi-square test: P=.516). CONCLUSIONS: Compared with other patients who had cancer, patients who were participating in phase 1 trials were less likely to want several home care services, although they experienced a greater symptom burden. Further research will be needed to define the palliative care needs of this population.

The terrible choice: re-evaluating hospice eligibility criteria for cancer.

PURPOSE: To be eligible for the Medicare Hospice Benefit, cancer patients with a life expectancy of 6 months or less must give up curative treatment. Our goal was to determine whether willingness to make this choice identifies patients with greater need for hospice services. PATIENTS AND METHODS: Three hundred patients with cancer and 171 family members were recruited from six oncology practices. Respondents completed conjoint interviews in which their perceived need for five hospice services was calculated from the choices they made among combinations of services. Patients' preferences for treatment were measured, and patients were followed for 6 months or until death. RESULTS: Thirty-eight patients (13%) said they would not want cancer treatment even if it offered an almost 100% chance of 6-month survival. These patients, who would have been eligible for hospice, did not have greater perceived need for hospice services compared with other patients (n = 262; mean, 1.75 v 1.98; Wilcoxon rank sum test, P = .46), nor did their family members (mean, 1.95 v 2.04; Wilcoxon rank sum test, P = .80). Instead, independent predictors of patients' perceived need for hospice services included African American ethnicity, less social support, worse functional status, and a greater burden of psychological symptoms. For families, predictors included caregiver burden, worse self-reported health, working outside the home, and caring for a patient with worse functional status. CONCLUSION: The requirement that patients forgo life-sustaining treatment does not identify patients with greater perceived need for hospice services. Other characteristics offer a better way to identify the patients who are most likely to benefit from hospice.