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| Name | Class |
|---|---|
| University of Modena and Reggio Emilia | OTHER |
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Prostate cancer (PCa) is among the most widespread in the male population and represents 20% of all cancers diagnosed from the age of fifty, in Italy. Androgen deprivation therapy (ADT) is a common strategy of treatment that is used for increase survival. However, ADT is associated with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive decline and reduced quality of life, with an increased the risk for falls and fractures, cardiometabolic syndrome and cardiovascular events.
The numerous side effects from ADT could potentially be countered by the regular Physical Exercise (PE), with favorable effects on body composition, physical performance, bone health and cognitive function.
However, to maintain the results obtained, PE must be undertaken regularly, becoming a healthy habit of life. The patient motivation is therefore a fundamental element for guaranteeing adherence to the intervention and its integration into people's lifestyle.
The study aim is to analyzed patients with PCa at the time of diagnosis regarding their lifestyle, includes regular PE, and motivation to make changes about their habits. In addition, the investigators will describe the perceived barriers by patients about this change.
The data collected will allow the development of an experimental intervention of PE, associated with therapeutic education, and assess its impact on the health of patient undergoing ADT, considering the realistic possibilities of application in the daily life of these patients, testing its feasibility and safety, the compliance and the satisfaction of the patients.
Participants will be invited to an interview guided by open-ended questions, focused on collecting information related to the usual lifestyle, the motivation to undertake healthy changes and the perceived barriers to adopting an healthy lifestyle. In particular, the interview is focused on collecting the following information:
During the interview, all patients will receive information about the importance of adopting a healthy lifestyle for the prevention of various diseases and even more to counteract the negative effects of PCa care. By adopting the Transtheoretical Model of Change (by Prochaska and DiClemente), will be identified the stage of motivation to change the risk factor identified through the interview. Consequently, these patients will receive a personalized message, with the aim of promoting change to healthy behavior. All patients will be informed about the existence and purpose of the Life Style Service in collaboration with LILT (Italian League for the Fight against Cancer) of the Health Information Service, active at CORE, at the Santa Maria Nuova Hospital in Reggio Emilia. In particular, patients in the "contemplation stage" will be informed about the possibility of contacting the clinic spontaneously at any time.The researcher will send the request to the public health clinic.
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| Measure | Description | Time Frame |
|---|---|---|
| Identification the risk factor for health of the newly diagnosed patients with PCa | The presence of factors that influence healthy lifestyle will be identified throught a questionnaire with data and personal information, and clinical data: the stage of the tumor, ongoing/planned therapies, presence of comorbidity (Charlson index). The daily habits of patients, such as smooking, eating and drinking habits will be investigated with open question, with specific section about the level of PE performed (type, intensity and frequency). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Investigation of the presence of cognitive disfunction | Date will be collected with the Mini Mental State Examination (MMSE) and through a questionnaire on the subjective perception of the prior cognitive state. | Baseline |
| Investigation the motivation to change and perceived barriers |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible participants for this study are men with newly PCa diagnosis, possible candidates to radical prostatectomy, radiotherapy and/or androgen deprivation therapy. Patients will be enrolled from the community across the province of Reggio Emilia.
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Costantini, Dr | Azienda Unità sanitaria Locale - IRCCS di Reggio Emilia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda USL - IRCCS | Reggio Emilia | Italy | 42122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35194723 | Derived | Bressi B, Iotti C, Cagliari M, Fugazzaro S, Cavuto S, Bergamaschi FAM, Moscato A, Costi S. Physical exercise habits, lifestyle behaviors, and motivation to change among men with prostate cancer: a cross-sectional study. Support Care Cancer. 2022 Jun;30(6):5017-5026. doi: 10.1007/s00520-022-06911-z. Epub 2022 Feb 22. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| D015438 | Health Behavior |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The influence of risk factor for health status, the motivation to change and the perceived barriers will be identified with a specific guided interview by the Prochaska and DiClemente's Transtheoretical Model (Stages of Change). |
| Baseline |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |