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| ID | Type | Description | Link |
|---|---|---|---|
| MC1091 | Other Identifier | Mayo Clinic |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study is being done to try out questions from a large set of questions called the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a set of questions which asks patients about their symptoms. This study will look at properties of these questions and will provide information about how these questions can be improved for research studies. PRO-CTCAE questions were developed under a contract from the National Cancer Institute (NCI) to allow patients to self-report symptoms in future cancer clinical trials. Patients with cancer receiving treatment will complete a web-based questionnaire containing PRO-CTCAE questions and a paper booklet containing a commonly used questionnaire for assessing quality of life, functioning, and symptoms at two visits one to six weeks apart. Some patients will additionally complete web-based questionnaires containing PRO-CTCAE questions weekly for four to five weeks, while completing a daily questionnaire containing PRO-CTCAE questions using an automated telephone system. Lastly, a small number of patients will complete only a single visit in which a web-based, telephone-based, and paper-based questionnaire containing PRO-CTCAE items is completed in addition to a paper booklet containing a commonly used questionnaire for assessing quality of life, functioning, and symptoms. The primary hypothesis is that scores for PRO-CTCAE questions will differ between patients with high versus low general well-being as measured by your doctor using a scale called the Eastern Cooperative Oncology Group Performance Score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer patients receiving treatment | Patients receiving active treatment for cancer or initiating treatment for cancer in the next 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in PRO-CTCAE item scores between patients with good and poor performance status at the first visit (study day 1) | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients initiating or receiving chemotherapy, radiation therapy, or both at nine U.S.-based cancer centers and community oncology practices were approached in clinical waiting areas and invited to participate in this questionnaire-based study.
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| Name | Affiliation | Role |
|---|---|---|
| Amylou C. Dueck, PhD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Hospital of Orange | Orange | California | 92868 | United States | ||
| Hartford Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41228252 | Derived | Lee MK, Mitchell SA, Basch E, Deal AM, Langlais BT, Thanarajasingam G, Ginos BF, Rogak L, Mendoza TR, Bennett AV, Noble BN, Mazza GL, Dueck AC. Psychometric Properties and Interpretability of PRO-CTCAE(R) Average Composite Scores as a Summary Metric of Symptomatic Adverse Event Burden. Cancers (Basel). 2025 Oct 28;17(21):3459. doi: 10.3390/cancers17213459. | |
| 39503942 |
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| Hartford |
| Connecticut |
| 06102 |
| United States |
| Christiana Care Health Services | Wilmington | Delaware | 19899 | United States |
| The Cancer Program of Our Lady of the Lake and Mary Bird Perkins | Baton Rouge | Louisiana | 70809 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan-Kettering Cancer | New York | New York | 10065 | United States |
| Gibbs Cancer Center | Spartanburg | South Carolina | 29303 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Lee MK, Mitchell SA, Basch E, Mazza GL, Langlais BT, Thanarajasingam G, Ginos BF, Rogak L, Meek EA, Jansen J, Deal AM, Carr P, Blinder VS, Jonsson M, Mody GN, Mendoza TR, Bennett AV, Schrag D, Dueck AC. Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE(R)). Qual Life Res. 2025 Feb;34(2):495-507. doi: 10.1007/s11136-024-03819-5. Epub 2024 Nov 6. |
| 39440720 | Derived | Mead-Harvey C, Basch E, Rogak LJ, Langlais BT, Thanarajasingam G, Ginos BF, Lee MK, Yee C, Mitchell SA, Minasian LM, Mendoza TR, Bennett AV, Schrag D, Dueck AC, Mazza GL. Statistical properties of items and summary scores from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE(R)) in a diverse cancer sample. Clin Trials. 2025 Apr;22(2):161-169. doi: 10.1177/17407745241286065. Epub 2024 Oct 23. |
| 26892667 | Derived | Bennett AV, Dueck AC, Mitchell SA, Mendoza TR, Reeve BB, Atkinson TM, Castro KM, Denicoff A, Rogak LJ, Harness JK, Bearden JD, Bryant D, Siegel RD, Schrag D, Basch E; National Cancer Institute PRO-CTCAE Study Group. Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Health Qual Life Outcomes. 2016 Feb 19;14:24. doi: 10.1186/s12955-016-0426-6. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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