RecruitingNCT06080607

PRO Survivorship Concerns ITA

Rehabilitation Needs in Patients With Early Breast Cancer: Validation of a Questionnaire Patient Reported Outcome


Sponsor

Regina Elena Cancer Institute

Enrollment

280 participants

Start Date

Jan 18, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • 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 Criteria1

  • Patients with cognitive or memory impairment wil be excluded

Interventions

BEHAVIORALPatient Reported Outcome (PRO)

Quality of Life evaluation


Locations(2)

Regina Elena Cancer Institute

Rome, Roma, Italy

"Regina Elena" National Cancer Institute

Rome, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06080607


Related Trials