Prostatic NeoplasmPCa_LSNCT03982095
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
An observational study of Prostatic Neoplasm and Physical Activity, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm, Physical Activity, Health Behavior
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2019to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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:
- the level of PE: type, frequency and intensity;
- the presence of health risk factors such as smoking, eating and drinking habits;
- 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;
- the stage of motivation to the adoption of healthy lifestyle that includes regular PE;
- 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.
- Keywords
- Prostatic neoplasm, Physical therapy modalities, Healthy lifestyle, Biobehavioral Sciences
- Medical subject headings
- Prostatic Neoplasms, Motor Activity, Health Behavior, Sedentary Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (2)
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.
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start4 Sep 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Collaborators
- University of Modena and Reggio Emilia
- Responsible party
- Sponsor
- Investigators
- Massimo Costantini, Dr, Study chair, Azienda Unità sanitaria Locale - IRCCS di Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982095
- Sponsor's protocol ID
- PCa_Oss_2019
- Acronym
- PCa_LS
- Status last verified
- Nov 2021
- First submitted
- 8 May 2019
- Last updated
- 20 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35194723
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT03982095
- Acronym / sponsor ID
- PCa_LS / PCa_Oss_2019
- Keywords
- Prostatic neoplasm, Physical therapy modalities, Healthy lifestyle, Biobehavioral Sciences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Collaborators
- University of Modena and Reggio Emilia
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- the level of PE: type, frequency and intensity;
- the presence of health risk factors such as smoking, eating and drinking habits;
- 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;
- the stage of motivation to the adoption of healthy lifestyle that includes regular PE;
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification the risk factor for health of the newly diagnosed patients with PCa
Time frame: Baseline
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).
2 secondary outcomes
Investigation of the presence of cognitive disfunction
Time frame: Baseline
Investigation the motivation to change and perceived barriers
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2025.
- Derived from this study: PubMed 35194723Bressi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Costantini, Dr study chair
Azienda Unità sanitaria Locale - IRCCS di Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasm and Physical Activity, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification the risk factor for health of the newly diagnosed patients with PCa (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2025.