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NCT01517152
Testing a Spanish Version of a Patient Toxicity Questionnaire
trial in Breast Cancer in 112 participants. Completed in 9 October 2018.
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 112 |
| Start date | 4 January 2012 |
| Estimated completion | 9 October 2018 |
| Sites | 1 location across United States |
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Colon Cancer — all drugs for Colon Cancer →
- Lung Cancer — all drugs for Lung Cancer →
- Lymphoma — all drugs for Lymphoma →
Sponsor
National Cancer Institute (NCI)
Who can join
Adults 18 to 100, any sex, with Breast Cancer or Colon Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: * The Common Terminology Criteria for Adverse Events (CTCAE) is a list of toxicities and side effects that may occur when people are having cancer treatment. Doctors and nurses use this list to describe the side effects patients experience from cancer treatment. We have developed a questionnaire to ask people having cancer treatment directly about common symptoms and side effects and to supply this information to their doctors and nurses. This questionnaire is known as PRO-CTCAE and is completed by a patient. * PRO-CTCAE was originally developed in English. Researchers want to develop a Spanish version of the patient questionnaire. To test whether the questions are well understood and whether it is easy to complete the questionnaire, the researchers will interview individuals whose primary language is Spanish and who are being treated for different types of cancer. Objectives: \- To test a Spanish version of the PRO-CTCAE questionnaire. Eligibility: \- Latinos at least 18 years of age who are having or have recently finished cancer treatments and whose main language is Spanish Design: * Participants will complete a questionnaire in Spanish with selected questions from the translated PRO-CTCAE. They will discuss their answers and any difficulties they might have had in understanding or answer the questions with an interviewer, who will take notes and record comments and suggestions. * Literacy is not required for this study. Participants may opt to have the questions read aloud to them by an interviewer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01517152 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 16 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01517152.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing