NCT02381054

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

February 27, 2015

Last Update Submit

June 27, 2017

Conditions

Cancer

Keywords

Patient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • cultural and linguistic validity of Italian language version of the PRO-CTCAE

    2 years

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients judged unable to report on their symptoms from the last seven days due to cognitive impairment.
  • Eligibility Criteria for Validation phase:
  • ≥18 years of age.
  • Patient is able to complete PRO-CTCAE on two consecutive days.
  • 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
  • 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..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

IRCCS Istituto Oncologico"Giovanni Paolo II"

Bari, Italy

Location

Ospedale "A.Perrino"

Brindisi, Italy

Location

Istituti Ospitalieri

Cremona, Italy

Location

IRCCS AOU San Martino -IST

Genova, Italy

Location

AOU Policlinico G.Martino

Messina, Italy

Location

Istituto Nazionale Tumori

Milan, Italy

Location

Istituto Nazionale Tumori - Fondazione Pascale

Napoli, Italy

Location

Istituto Oncologico Veneto

Padua, Italy

Location

IRCCS Policlinico S.Matteo

Pavia, Italy

Location

A.O. Sant'Andrea

Roma, Italy

Location

Ospedale San Camillo Forlanini

Roma, Italy

Location

Policlinico Umberto I

Roma, Italy

Location

Ospedale Civile SS.Annunziata

Sassari, Italy

Location

Ospedale Valdelsa di Poggibonsi

Siena, Italy

Location

AOU San Luigi Orbassano

Torino, Italy

Location

Policlinico Universitario G.B.Rossi

Verona, Italy

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Francesco Perrone

    National Cancer Institute, Naples

    PRINCIPAL INVESTIGATOR

  • Caterina Caminiti

    Parma University Hospital

    PRINCIPAL INVESTIGATOR

  • Michela Bagnalasta

    Smith Kline Foundation

    PRINCIPAL INVESTIGATOR

  • Fabio Arpinelli

    Smith Kline Foundation

    PRINCIPAL INVESTIGATOR

  • Maurizio Bassi

    Smith Kline Foundation

    PRINCIPAL INVESTIGATOR

  • Pierpaolo Betteto

    F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations

    PRINCIPAL INVESTIGATOR

  • Lucia Del Mastro

    IRCCS AOU San Martino -IST, National Cancer Research Institute

    PRINCIPAL INVESTIGATOR

  • Davide De Persis

    F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations

    PRINCIPAL INVESTIGATOR

  • Elisabetta Iannelli

    F.A.V.O. Italian Federation of Volunteer-Based Cancer Organizations

    PRINCIPAL INVESTIGATOR

  • Anna Lisa Nicelli

    Smith Kline Foundation

    PRINCIPAL INVESTIGATOR

  • Rodolfo Passalacqua

    Istituti Ospitalieri Cremona

    PRINCIPAL INVESTIGATOR

  • Camillo Porta

    Fondazione I.R.C.C.S. Policlinico San Matteo

    PRINCIPAL INVESTIGATOR

  • Jane Bryce

    National Cancer Institute, Naples

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 6, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2017

Study Completion

June 22, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

IT(16)