Breast Neoplasm Female, Psychological Distress, Quality of Life
Conditions
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.
Interventions
BEHAVIORALPatient Reported Outcome (PRO)
Quality of Life evaluation
Sponsors
Centro di Riferimento Oncologico - Aviano
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Istituti Tumori Giovanni Paolo II
Fondazione Salvatore Maugeri
Regina Elena Cancer Institute
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactPatrizia Pugliese
Backup ContactChiara Falcicchio
Outcome results
None listed