Clinical trial · Observational
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Health Behavior | — | UNRESOLVED | — |
| Lifestyle, Sedentary | — | UNRESOLVED | — |
| Physical Activity | — | UNRESOLVED | — |
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Identification the risk factor for health of the newly diagnosed patients with PCa
- timeFrame
- Baseline
- description
- 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).
Secondary outcomes (2)
- measure
- Investigation of the presence of cognitive disfunction
- timeFrame
- Baseline
- description
- Date will be collected with the Mini Mental State Examination (MMSE) and through a questionnaire on the subjective perception of the prior cognitive state.
- measure
- Investigation the motivation to change and perceived barriers
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * newly diagnosed with histologically documented prostate cancer; * at least 18 years old; * willing and able to give written informed consent; * able to read and understand Italian Language; Exclusion Criteria: * patients undergoing major surgery in the three months prior to diagnosis of prostate cancer, which caused a change in lifestyle during the three months prior to PCa diagnosis
References
Publications (1)
- DERIVEDBressi 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. PMID 35194723