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PRO Survivorship Concerns ITA

NCT06080607 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 280

Last updated 2024-03-25

No results posted yet for this study

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

Interventions

BEHAVIORAL

Patient Reported Outcome (PRO)

Quality of Life evaluation

Sponsors & Collaborators

  • Centro di Riferimento Oncologico - Aviano

    collaborator OTHER

  • Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

    collaborator NETWORK

  • Istituti Tumori Giovanni Paolo II

    collaborator NETWORK

  • Fondazione Salvatore Maugeri

    collaborator OTHER

  • Regina Elena Cancer Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2024-06-18
Completion
2024-06-18

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06080607 on ClinicalTrials.gov