PRO Survivorship Concerns ITA

NCT ID: NCT06080607

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-18

Study Completion Date

2024-06-18

Brief Summary

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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

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Conditions

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Breast Neoplasm Female Quality of Life Psychological Distress

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Patient Reported Outcome (PRO)

Quality of Life evaluation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role collaborator

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

NETWORK

Sponsor Role collaborator

Istituti Tumori Giovanni Paolo II

NETWORK

Sponsor Role collaborator

Fondazione Salvatore Maugeri

OTHER

Sponsor Role collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Regina Elena Cancer Institute

Rome, Roma, Italy

Site Status ACTIVE_NOT_RECRUITING

"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Patrizia Pugliese

Role: CONTACT

+39 06 52666155

Chiara Falcicchio

Role: CONTACT

+39 06 52666155

Other Identifiers

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RS1272/19

Identifier Type: -

Identifier Source: org_study_id

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