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

Plain Language Summary

Simplified for easier understanding

This study is creating and testing a questionnaire designed to help cancer survivors talk about their concerns and worries after finishing treatment. The goal is to make sure the questionnaire works well across different languages and cultures. **You may be eligible if...** - You are a cancer patient or survivor who is willing to complete a survey - You are being treated or followed up at the participating medical center - You are able to recall and process information clearly **You may NOT be eligible if...** - You have cognitive impairment or significant memory problems that would prevent you from completing the questionnaire Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT06080607


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