PRO Survivorship Concerns ITA

Recruiting

• Conditions: Psychological Distress; Breast Neoplasm Female; Quality of Life

• Registration Number: NCT06080607
• Lead Sponsor: Regina Elena Cancer Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25
• Primary Completion: 2024-06-18
• Study Completion: 2024-06-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Translation and validation of questionnaire PRO	6 months	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.; the PRO questionnaire "survivorship concerns" is made up of 17 items which evaluate the problems of survival, the level of concern about problems related to the care of patients, screening, symptom management, family and genetic problems and the fear of disease recurrence, on a scale of 0 to 3.It will be administered twice 15 days apart and in order to identify the levels of agreement between the two assessments, the Interclass Correlation Coefficient (ICC) model 3.1 will be applied and calculated for each item.

Trial Locations

Locations (2)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy

Regina Elena Cancer Institute; 🇮🇹 Rome, Roma, Italy