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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
Regina Elena Cancer Institute
ACTIVE_NOT_RECRUITING
Rome
Regina Elena National Cancer Institute
RECRUITING
Rome
Contact Information
Primary
Patrizia Pugliese
patrizia.pugliese@ifo.gov.it
+39 06 52666155
Backup
Chiara Falcicchio
chiara.falcicchio@ifo.it
+39 06 52666155
Time Frame
Start Date: 2022-01-18
Estimated Completion Date: 2024-06-18
Participants
Target number of participants: 280
Related Therapeutic Areas
Sponsors
Collaborators: Fondazione Salvatore Maugeri, Istituti Tumori Giovanni Paolo II, Centro di Riferimento Oncologico - Aviano, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Leads: Regina Elena Cancer Institute

This content was sourced from clinicaltrials.gov