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Trial Title:
PRO Survivorship Concerns ITA
NCT ID:
NCT06080607
Condition:
Breast Neoplasm Female
Quality of Life
Psychological Distress
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Patient Reported Outcome (PRO)
Description:
Quality of Life evaluation
Summary:
Breast cancer survivors typically experience fatigue, pain, insomnia, depression,
anxiety, difficulty in concentrating, memory impairment, body image problems, vaginal
dryness, interest in sex decreasing, hot flashes, gain weight, and infertility. All of
these problems affect quality of life (QoL) mainly during the early survival and they
become even more important to understand and address if long-term effects could be
prevented.
The use of PROs in care settings has demonstrated improvement in provider/patient
communication, recognition of previously unrecognized issues, as well as patient
satisfaction with care.
In order to allow to patients the use of the PRO "survivorship concerns" in their mother
tongue, it is imprtant to have validated translations with transcultural adaptation. The
main goals of this multicentric study are the translation, adaptability and transcultural
validation of the PRO questionnaire "survivorship concerns" to put in evidence
rehabilitation needs in breast cancer patients in early stage.
Criteria for eligibility:
Study pop:
Breast cancer women patients
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- During transcultural adaptability 80 representative patients will be recruited .
During the validation phase previus patients will be included and more other patients
will be included (at least 280)
Exclusion Criteria:
- Patients with cognitive or memory impairment wil be excluded
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Regina Elena Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Start date:
January 18, 2022
Completion date:
June 18, 2024
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Collaborator:
Agency:
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Agency class:
Other
Collaborator:
Agency:
Istituti Tumori Giovanni Paolo II
Agency class:
Other
Collaborator:
Agency:
Fondazione Salvatore Maugeri
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06080607
