PRO Survivorship Concerns ITA

Sponsor

Regina Elena Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT06080607

Collaborator

(none)

280

Enrollment

Locations

50.3

Anticipated Duration (Months)

140

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Female Quality of Life Psychological Distress	Behavioral: Patient Reported Outcome (PRO)

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

280 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Rehabilitation Needs in Early Stage Breast Cancer Patients: Validation of the Questionnaire "Patient Reported Outcome"

Actual Study Start Date :

Oct 22, 2019

Actual Primary Completion Date :

Sep 19, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regina Elena Cancer Institute	Rome	Roma	Italy	00144
2	"Regina Elena" National Cancer Institute	Rome		Italy	00144

Sponsors and Collaborators

Regina Elena Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Regina Elena Cancer Institute

ClinicalTrials.gov Identifier:

NCT06080607

Other Study ID Numbers:

RS1272/19

First Posted:

Oct 12, 2023

Last Update Posted:

Oct 12, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Oct 12, 2023