Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer

NCT03982095 | Completed

• 1 other identifier: PCa_Oss_2019
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostatic Neoplasm; Physical Activity; Health Behavior; Lifestyle, Sedentary

Keywords

Prostatic neoplasm; Physical therapy modalities; Healthy lifestyle; Biobehavioral Sciences

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Investigation of the presence of cognitive disfunction

  Baseline

• Investigation the motivation to change and perceived barriers

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• University of Modena and Reggio Emilia: collaborator

Study Sites (1)

Azienda USL - IRCCS

Reggio Emilia, Italy, 42122, Italy

Location

Related Publications (1)

• 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.

  PMID: 35194723 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity; Health Behavior; Sedentary Behavior

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Massimo Costantini, Dr

  Azienda Unità sanitaria Locale - IRCCS di Reggio Emilia

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: June 11, 2019
• Study Start: September 4, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: June 20, 2025

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)