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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Health Behavior; Prostatic Neoplasm; Lifestyle, Sedentary

Detailed Description

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:

1. the level of PE: type, frequency and intensity;
2. the presence of health risk factors such as smoking, eating and drinking habits;
3. the presence of cognitive disorders, investigated through the Mini Mental State Examination and through some questions aimed at catching the subjective perception of one's cognitive state;
4. the stage of motivation to the adoption of healthy lifestyle that includes regular PE;
5. the perceived barriers to one's ability to change one's lifestyle by adopting a regular habit of PE.

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • Reggio Emilia, Italy, 42122
    • Azienda USL - IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Arcispedale Santa Maria Nuova-IRCCS
• Collaborators: University of Modena and Reggio Emilia
• Investigators: Study Chair: Massimo Costantini, Dr, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): November 10, 2021
• Study Completion (Actual): November 10, 2021

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Physical therapy modalities; Healthy lifestyle; Prostatic neoplasm; Biobehavioral Sciences
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PCa_Oss_2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No