TY - JOUR
T1 - Using patient-reported outcomes to describe the patient experience on phase I clinical trials
AU - Sedhom, Ramy
AU - Ferrell, Betty
AU - Ruel, Nora
AU - Koczywas, Marianna
AU - Chung, Vincent
AU - Smith, Thomas J.
N1 - Funding Information:
This research is supported by a research grant from NCI-RO1 CA177562, “Integration of Palliative Care for Cancer Patients on Phase 1 Trials” (B. Ferrell, T. Smith: Co-PIs); the City of Hope Core, NCI P30CA033572; and the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Core Grant, NCI.
Funding Information:
This research is supported by a research grant from NCIRO1 CA177562, “Integration of Palliative Care for Cancer Patients on Phase 1 Trials” (B. Ferrell, T. Smith: Co-PIs); the City of Hope Core, NCI P30CA033572; and the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Core Grant, NCI.
Publisher Copyright:
© The Author(s) 2020.
PY - 2020
Y1 - 2020
N2 - Background: Symptoms are common among patients enrolled in phase I trials. We assessed the validity of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items in relation to previously validated assessments of quality of life and psychological distress. We used data from a randomized trial testing a palliative care support intervention for patients enrolled on phase I trials. Methods: Patients (n ¼ 479) were accrued to the parent study prior to initiating a phase I clinical trial with data collected at baseline, 4, and 12 weeks. We determined the correlation of PRO-CTCAE with distress level, Functional Assessment of Cancer Therapy - General (FACT-G) total, and subscale domain scores. Results: Patients were predominantly female (56.8%) and older than age 60 years, and 30.7% were from minority populations. The correlation coefficient for distress level for all PRO-CTCAE items was small to moderate (Pearson r ¼ 0.33-0.46). Pearson correlation coefficient for FACT-G total was moderate (r ¼ -0.45 to -0.69). Stronger associations were noted for mood items of the PRO-CTCAE only (with distress level, r ¼ 0.55-0.6; with FACT-G, r ¼ -0.54 to -0.6). PRO-CTCAE symptom interference scores had the strongest correlation with distress level (Pearson r ¼ 0.46) and FACT-G total (Pearson r ¼ -0.69). Correlations between PRO-CTCAE items and corresponding FACT-G (total and subscales) and distress levels reached statistical significance for all items (P <.001). Conclusion: Evidence demonstrates validity of PRO-CTCAE in a heterogeneous US sample of patients undergoing cancer treatment on phase I trials, with small to moderate correlations with distress level for all PRO-CTCAE items and moderate correlations with quality of life as measured by FACT-G total.
AB - Background: Symptoms are common among patients enrolled in phase I trials. We assessed the validity of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items in relation to previously validated assessments of quality of life and psychological distress. We used data from a randomized trial testing a palliative care support intervention for patients enrolled on phase I trials. Methods: Patients (n ¼ 479) were accrued to the parent study prior to initiating a phase I clinical trial with data collected at baseline, 4, and 12 weeks. We determined the correlation of PRO-CTCAE with distress level, Functional Assessment of Cancer Therapy - General (FACT-G) total, and subscale domain scores. Results: Patients were predominantly female (56.8%) and older than age 60 years, and 30.7% were from minority populations. The correlation coefficient for distress level for all PRO-CTCAE items was small to moderate (Pearson r ¼ 0.33-0.46). Pearson correlation coefficient for FACT-G total was moderate (r ¼ -0.45 to -0.69). Stronger associations were noted for mood items of the PRO-CTCAE only (with distress level, r ¼ 0.55-0.6; with FACT-G, r ¼ -0.54 to -0.6). PRO-CTCAE symptom interference scores had the strongest correlation with distress level (Pearson r ¼ 0.46) and FACT-G total (Pearson r ¼ -0.69). Correlations between PRO-CTCAE items and corresponding FACT-G (total and subscales) and distress levels reached statistical significance for all items (P <.001). Conclusion: Evidence demonstrates validity of PRO-CTCAE in a heterogeneous US sample of patients undergoing cancer treatment on phase I trials, with small to moderate correlations with distress level for all PRO-CTCAE items and moderate correlations with quality of life as measured by FACT-G total.
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U2 - 10.1093/JNCICS/PKAA067
DO - 10.1093/JNCICS/PKAA067
M3 - Article
AN - SCOPUS:85101341079
SN - 2515-5091
VL - 4
JO - JNCI Cancer Spectrum
JF - JNCI Cancer Spectrum
IS - 6
M1 - PKAA067
ER -