- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01016028
Chemotherapy-Induced Peripheral Neuropathy Survey
Chemotherapy-Induced Peripheral Neuropathy: Feasibility and Validity of New Symptom Measurement Tools in Patients on Treatment With Platinum Agents, Taxanes and Bortezomib
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
If patient agrees to take part in this study, they will be asked to complete 3 questionnaires, 3 sensory tests, and may be asked to take part in a one-on-one symptom interview.
Symptom Interview:
Depending on when patient is enrolled in this study, they may take part in a one-on-one interview with a study staff member. A total of 15 participants will take part in this interview (5 taking platinum agents, 5 taking taxanes, & 5 taking bortezomib). During the interview, patient will be asked to describe their symptoms. The interview should take about 20-30 minutes to complete.
The interviews will be digitally recorded, transcribed (typed), and used by researchers to identify symptoms related to receiving this type of chemotherapy. Researchers will use this information to design a study questionnaire that focuses on chemotherapy symptoms in the hands and feet. The digital recordings and typed copies of the interview will be destroyed after researchers have analyzed the interview data and the study is complete.
Questionnaires & Sensory Tests:
All study participants will complete 3 questionnaires that are designed to collect information about any pain and/or symptoms patient may have experienced, their general well-being, and personal information such as age and marital status. One (1) of them is called a symptom assessment questionnaire and patient be will asked to rate their symptoms on a scale of 0-10.
All study participants will also complete 3 tests, called sensory tests, that are designed to help researchers learn how sensitive patient is to things such as cold and touch. These tests involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board. Patient will also be asked to mark on computerized drawings the areas where they experience any pain, numbness, and/or cold sensitivity. A study staff member will explain how to take the tests and use the computerized drawings in more detail at the time these tests are performed.
It should take about 20-30 minutes to complete all of the questionnaires and tests.
Additional Sensory Testing:
Out of the 200 participants on this study, 40 participants will be asked to return to the clinic for additional sensory testing to help researchers learn if the tools used for this study are working as expected.
This additional testing is designed to help researchers learn how sensitive patient is to things such as touch, cold, warmth, and a pinprick to the finger, hand, or arm. Patient will be asked to describe how well they can feel each test, and how much pain they may or may not feel. This additional testing should take about 60 minutes to complete.
Length of Study:
After patient has completed the interview (if they are asked), 3 questionnaires, and 3 sensory tests their participation on this study will be over. If patient is selected to take part in the additional sensory testing, their participation on this study will be over after those tests are complete.
This is an investigational study.
Up to 200 participants will take part in this study. All will be enrolled at M. D. Anderson.
Tipo di studio
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients >= 18 years old.
- Patients must be fluent with the English language.
- Patients must be on chemotherapy regimes with any of the study drugs: cisplatin, oxaliplatin, taxanes and/or bortezomib.
Exclusion Criteria:
- Significant cognitive impairment as determined by the trained research staff
- Chronic alcoholism or substance abuse
- Diagnosis of severe depression
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Questionnaire + Sensory Tests + Interview
|
3 questionnaires to collect information about any pain and/or symptoms experienced, general well-being, and personal information such as age and marital status.
One (1) will be a symptom assessment questionnaire where asked to rate symptoms on a scale of 0-10.
Altri nomi:
Test of sensitivity to things such as cold and touch, involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board; and marking on computerized drawings areas experience pain, numbness, and/or cold sensitivity.
First 5 patients receiving platinum agents, taxanes, and bortezomib (15 patients total) will be asked to describe their symptoms in an open-ended, semi-structured 20-30 minute interview.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Assessment of Patient's Symptoms (Questionnaire)
Lasso di tempo: Each patient administered questionnaire at single point in time.
|
Each patient administered questionnaire at single point in time.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Charles Cleeland, PHD,BA, UT MD Anderson Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2009-0439
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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