NCT06080607

PRO Survivorship Concerns ITA

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 280 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasm Female
• Quality of Life
• Psychological Distress

Interventions

Type	Name	Description
BEHAVIORAL	Patient Reported Outcome (PRO)	Quality of Life evaluation

Timeline

• Start date: 2022-01-18
• Primary completion: 2024-06-18
• Completion: 2024-06-18
• First posted: 2023-10-12
• Last updated: 2024-03-25

Locations

2 sites across 1 country: Italy