PRO Survivorship Concerns ITA

Quality of Life Clinical Trial

— PRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080607
• Other study ID #: RS1272/19
• Status: Recruiting
• Start date: January 18, 2022
• Est. completion date: June 18, 2024

Study information

• Verified date: March 2024
• Source: Regina Elena Cancer Institute
• Contact: Patrizia Pugliese
• Phone: +39 06 52666155
• Email: patrizia.pugliese[@]ifo.gov.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 18, 2024
• Est. primary completion date: June 18, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Psychological Distress
• Quality of Life

Intervention

Behavioral:
• Patient Reported Outcome (PRO)
Quality of Life evaluation

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome
Italy	Regina Elena Cancer Institute	Rome	Roma

Sponsors (5)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Centro di Riferimento Oncologico - Aviano, Fondazione Salvatore Maugeri, Istituti Tumori Giovanni Paolo II, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Translation and validation of questionnaire PRO	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.	6 months