CancerPRO-CTCAENCT02381054
Translation, Cross-cultural Adaptation and Validation of PRO-CTCAE for Italian-speaking Cancer Patients
An observational study of Cancer, run by Italian PRO-CTCAE Study Group at 16 sites in Italy.
Trial summary
The purpose of this study is to see if the Italian language version of a questionnaire about symptoms that patients may have during cancer treatment is understandable to Italian speaking patients. The questionnaire is called the PRO-CTCAE, and was originally developed at the U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 233 participants
- Where
- 16 sitesItaly
- Study dates
- May 2015to 22 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients receiving or having recently received cancer therapy (chemotherapy, biologic therapy, and or radiation therapy) will be recruited from 17 Italian Cancer Institutes and Hospitals throughout Italy. Sampling will be performed to ensure that the target population is matched for gender, age and area of residence (North, center, and Southern Italy). Recruitment of at least 25% of patients with lower levels of educational attainment (i.e., primary school or no education) will also be ensured.
Who may be able to join
- patients receiving (or who have received within 6 months) chemotherapy or radiotherapy with curative or palliative intent for an advanced cancer at one of the study sites
- ≥18 years of age
- able to speak and understand Italian
- providing written informed consent
- ≥18 years of age.
- Patient is able to complete PRO-CTCAE on two consecutive days.
Show all 11Show fewer
- Patient is actively receivingmedical treatment for cancer or has completed treatment not more than 4 weeks before Visit 1
- Any type of cancer
- Able to complete questionnaire by themselves or with assistance.
- Providing informed written consent.
- Able to speak and understand Italian
Who cannot join
- Patients judged unable to report on their symptoms from the last seven days due to cognitive impairment.
- Eligibility Criteria for Validation phase:
- Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.
- Other important acute medical conditions that, in the opinion of the Investigator, may prevent compliance..
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Italy16 sites
IRCCS Istituto Oncologico"Giovanni Paolo II"
Bari
Ospedale "A.Perrino"
Brindisi
Istituti Ospitalieri
Cremona
IRCCS AOU San Martino -IST
Genova
AOU Policlinico G.Martino
Messina
Istituto Nazionale Tumori
Milan
Istituto Nazionale Tumori - Fondazione Pascale
Naples
Istituto Oncologico Veneto
Padova
IRCCS Policlinico S.Matteo
Pavia
A.O. Sant'Andrea
Roma
Ospedale San Camillo Forlanini
Roma
Policlinico Umberto I
Roma
Ospedale Civile SS.Annunziata
Sassari
Ospedale Valdelsa di Poggibonsi
Siena
AOU San Luigi Orbassano
Torino
Policlinico Universitario G.B.Rossi
Verona
About this study
Official title: Translation, Cross-Cultural Adaptation and Validation of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for Italian-speaking Cancer Patients
The purpose of this study is to see if the Italian language version of a questionnaire about symptoms that patients may have during cancer treatment is understandable to Italian speaking patients. The questionnaire is called the PRO-CTCAE, and was originally developed at the U.S. National Cancer Institute to help get information about patients' symptoms directly from the patients themselves. The Italian version of the questionnaire will be used in future studies to gain a better understanding of patient symptoms.
Read the detailed description
This study will be conducted in two steps. The first is the Italian translation and cross cultural adaptation of the original US NCI's version of the PRO-CTCAE questionnaire. The questionnaire will be translated and administered to a sample of 96 Italian patients. After protocol amendment in November 2016, the second step was modified and consists of test-retest reliability assessment of the Italian language version of the PRO-CTCAE questionnaire that was developed in the first step, with a minimum of 59 Italian speaking patients to be enrolled. A validation study is planned and will be the subject of a separate protocol.
- Conditions
- Cancer
- Keywords
- Patient reported outcomes
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Translation and cross-cultural adaptation phase | In this phase 96 Italian-speaking patients who are receiving cancer treatment or who have completed treatment for cancer within the past six months at one of the participating sites will first be asked to independently complete a series of PRO-CTCAE symptom items in a Patient Questionnaire. Following completion by the participant of the Patient Questionnaire containing PRO-CTCAE items, the interviewer will elicit participants' feedback regarding item comprehension, symptomatic adverse event terms, attribute terms, 7-day recall period, and response options, via a semi-scripted cognitive debriefing interview developed to assure consistency across interviews. | |
| Test-retest phase | In this phase a minimum of 59 Italian-speaking patients who are receiving cancer treatment will be asked to independently complete the Italian version PRO-CTCAE questionnaire on 2 consecutive business days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cultural and linguistic validity of Italian language version of the PRO-CTCAE
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2017
- Study completion22 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italian PRO-CTCAE Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, Naples, F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations, SmithKline Foundation, Parma University Hospital, IRCCS AOU San Martino -IST Genoa, Istituti Ospitalieri di Cremona, Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Sponsor
- Investigators
- Francesco Perrone, Principal investigator, National Cancer Institute, NaplesCaterina Caminiti, Principal investigator, Parma University HospitalMichela Bagnalasta, Principal investigator, Smith Kline FoundationFabio Arpinelli, Principal investigator, Smith Kline FoundationMaurizio Bassi, Principal investigator, Smith Kline FoundationPierpaolo Betteto, Principal investigator, F.A.V.O. Italian Federation of Volunteer-Based Cancer OrganizationsLucia Del Mastro, Principal investigator, IRCCS AOU San Martino -IST, National Cancer Research InstituteDavide De Persis, Principal investigator, F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381054
- Sponsor's protocol ID
- Italian PRO-CTCAE
- Acronym
- PRO-CTCAE
- Status last verified
- Jun 2017
- First submitted
- 27 Feb 2015
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-Cultural Adaptation and Validation of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for Italian-speaking Cancer Patients
- ClinicalTrials.gov ID
- NCT02381054
- Acronym / sponsor ID
- PRO-CTCAE / Italian PRO-CTCAE
- Conditions
- Cancer
- Keywords
- Patient reported outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Italian PRO-CTCAE Study GroupUniversity, hospital or other
- Collaborators
- National Cancer Institute, Naples, F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations, SmithKline Foundation, Parma University Hospital, IRCCS AOU San Martino -IST Genoa, Istituti Ospitalieri di Cremona, Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- May 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the Italian language version of a questionnaire about symptoms that patients may have during cancer treatment is understandable to Italian speaking patients. The questionnaire is called the PRO-CTCAE, and was originally developed at the U.S. National Cancer Institute to help get information about patients' symptoms directly from the patients themselves. The Italian version of the questionnaire will be used in future studies to gain a better understanding of patient symptoms.
Detailed description
This study will be conducted in two steps. The first is the Italian translation and cross cultural adaptation of the original US NCI's version of the PRO-CTCAE questionnaire. The questionnaire will be translated and administered to a sample of 96 Italian patients. After protocol amendment in November 2016, the second step was modified and consists of test-retest reliability assessment of the Italian language version of the PRO-CTCAE questionnaire that was developed in the first step, with a minimum of 59 Italian speaking patients to be enrolled. A validation study is planned and will be the subject of a separate protocol.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Translation and cross-cultural adaptation phase | – | –In this phase 96 Italian-speaking patients who are receiving cancer treatment or who have completed treatment for cancer within the past six months at one of the participating sites will first be asked to independently complete a series of PRO-CTCAE symptom items in a Patient Questionnaire. Following completion by the participant of the Patient Questionnaire containing PRO-CTCAE items, the interviewer will elicit participants' feedback regarding item comprehension, symptomatic adverse event terms, attribute terms, 7-day recall period, and response options, via a semi-scripted cognitive debriefing interview developed to assure consistency across interviews. |
| Test-retest phase | – | –In this phase a minimum of 59 Italian-speaking patients who are receiving cancer treatment will be asked to independently complete the Italian version PRO-CTCAE questionnaire on 2 consecutive business days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving or having recently received cancer therapy (chemotherapy, biologic therapy, and or radiation therapy) will be recruited from 17 Italian Cancer Institutes and Hospitals throughout Italy. Sampling will be performed to ensure that the target population is matched for gender, age and area of residence (North, center, and Southern Italy). Recruitment of at least 25% of patients with lower levels of educational attainment (i.e., primary school or no education) will also be ensured.
Key inclusion criteria (11 listed)
- patients receiving (or who have received within 6 months) chemotherapy or radiotherapy with curative or palliative intent for an advanced cancer at one of the study sites
- ≥18 years of age
- able to speak and understand Italian
- providing written informed consent
- ≥18 years of age.
Key exclusion criteria (4 listed)
- Patients judged unable to report on their symptoms from the last seven days due to cognitive impairment.
- Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.
- Other important acute medical conditions that, in the opinion of the Investigator, may prevent compliance..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cultural and linguistic validity of Italian language version of the PRO-CTCAE
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Perrone principal investigator
National Cancer Institute, Naples
Caterina Caminiti principal investigator
Parma University Hospital
Michela Bagnalasta principal investigator
Smith Kline Foundation
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Italian PRO-CTCAE Study Group at 16 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cultural and linguistic validity of Italian language version of the PRO-CTCAE (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.