Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centro di Riferimento Oncologico - Aviano | OTHER |
| Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale | NETWORK |
| Istituti Tumori Giovanni Paolo II | NETWORK |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Reported Outcome (PRO) | Behavioral | Quality of Life evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
During the validation phase previus patients will be included and more other patients will be included (at least 280)
Exclusion Criteria:
Not provided
Not provided
Not provided
Breast cancer women patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrizia Pugliese | Contact | +39 06 52666155 | patrizia.pugliese@ifo.gov.it | |
| Chiara Falcicchio | Contact | +39 06 52666155 | chiara.falcicchio@ifo.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regina Elena Cancer Institute | Active, not recruiting | Rome | Roma | 00144 | Italy | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
Not provided
Not provided
| Fondazione Salvatore Maugeri |
| OTHER |
Not provided
Not provided
Not provided
| "Regina Elena" National Cancer Institute |
| Recruiting |
| Rome |
| 00144 |
| Italy |
| D008919 |
| Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |