PRO Survivorship Concerns ITA

NCT06080607 | Recruiting

• 1 other identifier: RS1272/19
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasm Female; Quality of Life; Psychological Distress

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Patient Reported Outcome (PRO) BEHAVIORAL

Quality of Life evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer women patients

You may qualify if:

• 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)

You may not qualify if:

• Patients with cognitive or memory impairment wil be excluded

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Centro di Riferimento Oncologico - Aviano: collaborator
• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale: collaborator
• Istituti Tumori Giovanni Paolo II: collaborator
• Fondazione Salvatore Maugeri: collaborator

Study Sites (2)

Regina Elena Cancer Institute

Rome, Roma, 00144, Italy

ACTIVE NOT RECRUITING

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Interventions

Patient Reported Outcome Measures

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Central Study Contacts

Patrizia Pugliese

CONTACT

+39 06 52666155; patrizia.pugliese@ifo.gov.it

Chiara Falcicchio

CONTACT

+39 06 52666155; chiara.falcicchio@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: October 12, 2023
• Study Start: January 18, 2022
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

IT (2)