Cancer ProstateACTI_PAIRNCT03866785
Physical Activity Experiment on Male Prostate Cancer Patients
A study testing interview, Adult Physical Activity Questionnaire (APAQ) and Activity actigraph in people with Cancer Prostate, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
Prostate cancer is the most common cancer in France (56,841 cases in 2012). Although the benefits of physical activity (PA) in cancer patients are currently well established in the scientific literature, several studies have shown that this population is not sufficiently active. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer Prostate
- What is being tested?
- interview, Adult Physical Activity Questionnaire (APAQ) and Activity actigraph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Aug 2018to 14 Sep 2021
- Phase
- Interventional
- 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
Who may be able to join
- Major patient followed for prostate cancer:
- located or locally advanced,
- metastatic and / or resistant to castration and chemotherapy.
- Cancer diagnosed at least 1 year ago
- Patient affiliated or beneficiary to social security
- Signed informed consent.
- In more, step 2 = Patient with Physical Activity for at least 1 year
Who cannot join
- For step 1= In the course of cancer treatment (excluding hormonal therapy)
- For step 2= Patient in sedentary lifestyle
- For step 3=
- In the course of cancer treatment (excluding hormonal therapy)
- Cardiac or respiratory conditions contraindicating physical activity
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Saint-Etienne
Saint-Etienne
ICLN - département de radiothérapie
Saint-Priest-en-Jarez
ICLN - Oncologie médicale
Saint-Priest-en-Jarez
About this study
Official title: Physical Activity Experiment on Male Prostate Cancer Patients : Feasibility Multicenter Study of an Innovative Follow-up by Peers
Prostate cancer is the most common cancer in France (56,841 cases in 2012). Although the benefits of physical activity (PA) in cancer patients are currently well established in the scientific literature, several studies have shown that this population is not sufficiently active. Strengthen patient adherence to prevention counseling by the physical activity (PA) is emerging as a new challenge for personalized treatment in oncology. In order to encourage the engagement and maintenance in a regular PA of cancer patients, first, their experiences of physical activity (PA) practice should be considered and their initial social representations of the practice considered. Secondarily, it is also important to identify health professionals who retain a key role in defining the framework, objectives and means of action to promote lifestyle changes towards a more active lifestyle. In addition, peer mentoring appears to offer promising perspectives for promoting adherence and long-term maintenance in physical activity (PA) of cancer patients.
Read the detailed description
The main objective of this project is to measure the adherence of prostate cancer patients to a physical activity program with a tracking of the motivation by a pair.
- Conditions
- Cancer Prostate
- Being tested
- interview, Adult Physical Activity Questionnaire (APAQ), Activity actigraph, Peer training, Physical Activity Program
- Keywords
- Prostate cancer, Physical activity, Activity actigraph, Peer, Program, Sports medicine
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewDiagnostic test
The goal is to evaluate the needs, the constraints and representations of patients on the practice of physical activity.
Adult Physical Activity Questionnaire (APAQ)Diagnostic test
The goal of this questionnaire is to evaluate the sedentary lifestyle of patients.
Activity actigraphDevice
An activity actigraph will use by the patient for a week. It measures the level of physical activity and the sedentary lifestyle of patients.
Peer trainingOther
The goal of the peer training will organize once a week for 3 weeks for a patient.
After this training, they will have :
- Skills in physical activity advice
- Knowledge of functional signs (symptoms)
- Knowledge to examine heart rate and perceived effort rate
Physical Activity ProgramOther
During the Physical Activity Program, patients will be supervised by peers and a clubs and sports associations labeled sport-health by Olympic and Sports Committee of the Loire Department.
The peer will coach the patient once a week minimum for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| STEP 1: Patient with prostate cancer | Other | First, patients with prostate cancer will be included during step 1. They will have an interview. Receives: Diagnostic Test: interview |
| STEP 2: Patient with prostate cancer and a physical activity | Other | Secondly, patient with prostate cancer and a physical activity will be included during step 2. They are called "peer".
They will have a questionnaire Adult Physical Activity Questionnaire (APAQ), an activity actigraph and a peer training. The peer will help patients to realize the Physical Activity Program during step 3. Receives: Diagnostic Test: Adult Physical Activity Questionnaire (APAQ); Device: Activity actigraph; Other: Peer training |
| STEP 3: Physical Activity Program | Other | Finally, patients with prostate cancer (different from step 1) and who agrees to participate at the Physical Activity Program will be included during step 3.
They will have an activity actigraph and a questionnaire Adult Physical Activity Questionnaire (APAQ) at inclusion and 3 months later.
They will receive the Physical Activity Program. Receives: Diagnostic Test: Adult Physical Activity Questionnaire (APAQ); Device: Activity actigraph; Other: Physical Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity sessions performed
Analysis of the proportion (%) of Physical Activity sessions performed after 3 months of intervention.
Measured: At month 3
Secondary outcomes (6)
physical activity via activity actigraph
Assessment of physical activity via activity actigraph
Measured: At month 3
sedentary lifestyle via activity actigraph
Assessment of sedentary lifestyle via activity actigraph
Measured: At month 3
Patient's activation
Measure patient's activation via questionnaire Patient Activation Measure (PAM).
Measured: At month 3
brakes blocking intervention
Identification of brakes blocking intervention via interviews and Adult Physical Activity Questionnaire (APAQ). APAQ measures the sleeping time (h/night), sedentary time (h/week) and physical activity time (h/day)
Measured: At month 3
levers favoring intervention
Identification of levers favoring intervention via interviews and Adult Physical Activity Questionnaire (APAQ). APAQ measures the sleeping time (h/night), sedentary time (h/week) and physical activity time (h/day)
Measured: At month 3
Peers mobilized
Number of peers mobilized
Measured: At month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start2 Aug 2018
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ProstateStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is composed of 3 dependent steps.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- David HUPIN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866785
- Sponsor's protocol ID
- 18CH034
- Other IDs
- 2018-A00710-55
- Acronym
- ACTI_PAIR
- Status last verified
- Feb 2023
- First submitted
- 22 Oct 2018
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Experiment on Male Prostate Cancer Patients : Feasibility Multicenter Study of an Innovative Follow-up by Peers
- ClinicalTrials.gov ID
- NCT03866785
- Acronym / sponsor ID
- ACTI_PAIR / 18CH034
- Conditions
- Cancer Prostate
- Keywords
- Prostate cancer, Physical activity, Activity actigraph, Peer, Program, Sports medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 7 Mar 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 is the most common cancer in France (56,841 cases in 2012). Although the benefits of physical activity (PA) in cancer patients are currently well established in the scientific literature, several studies have shown that this population is not sufficiently active. Strengthen patient adherence to prevention counseling by the physical activity (PA) is emerging as a new challenge for personalized treatment in oncology. In order to encourage the engagement and maintenance in a regular PA of cancer patients, first, their experiences of physical activity (PA) practice should be considered and their initial social representations of the practice considered. Secondarily, it is also important to identify health professionals who retain a key role in defining the framework, objectives and means of action to promote lifestyle changes towards a more active lifestyle. In addition, peer mentoring appears to offer promising perspectives for promoting adherence and long-term maintenance in physical activity (PA) of cancer patients.
Detailed description
The main objective of this project is to measure the adherence of prostate cancer patients to a physical activity program with a tracking of the motivation by a pair.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is composed of 3 dependent steps.
| Arm | Type | Receives |
|---|---|---|
| STEP 1: Patient with prostate cancer | Other | Diagnostic Test: interviewFirst, patients with prostate cancer will be included during step 1. They will have an interview. |
| STEP 2: Patient with prostate cancer and a physical activity | Other | Diagnostic Test: Adult Physical Activity Questionnaire (APAQ), Device: Activity actigraph, Other: Peer trainingSecondly, patient with prostate cancer and a physical activity will be included during step 2. They are called "peer". They will have a questionnaire Adult Physical Activity Questionnaire (APAQ), an activity actigraph and a peer training. The peer will help patients to realize the Physical Activity Program during step 3. |
| STEP 3: Physical Activity Program | Other | Diagnostic Test: Adult Physical Activity Questionnaire (APAQ), Device: Activity actigraph, Other: Physical Activity ProgramFinally, patients with prostate cancer (different from step 1) and who agrees to participate at the Physical Activity Program will be included during step 3. They will have an activity actigraph and a questionnaire Adult Physical Activity Questionnaire (APAQ) at inclusion and 3 months later. They will receive the Physical Activity Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Major patient followed for prostate cancer:
- Cancer diagnosed at least 1 year ago
- Patient affiliated or beneficiary to social security
- Signed informed consent.
- In more, step 2 = Patient with Physical Activity for at least 1 year
Key exclusion criteria (5 listed)
- For step 1= In the course of cancer treatment (excluding hormonal therapy)
- For step 2= Patient in sedentary lifestyle
- For step 3=
- In the course of cancer treatment (excluding hormonal therapy)
- Cardiac or respiratory conditions contraindicating physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewThe goal is to evaluate the needs, the constraints and representations of patients on the practice of physical activity. | Diagnostic test | STEP 1: Patient with prostate cancer |
| Adult Physical Activity Questionnaire (APAQ)The goal of this questionnaire is to evaluate the sedentary lifestyle of patients. | Diagnostic test | STEP 2: Patient with prostate cancer and a physical activity, STEP 3: Physical Activity Program |
| Activity actigraphAn activity actigraph will use by the patient for a week. It measures the level of physical activity and the sedentary lifestyle of patients. | Device | STEP 2: Patient with prostate cancer and a physical activity, STEP 3: Physical Activity Program |
| Peer trainingThe goal of the peer training will organize once a week for 3 weeks for a patient. After this training, they will have : * Skills in physical activity advice * Knowledge of functional signs (symptoms) * Knowledge to examine heart rate and perceived effort rate | Other | STEP 2: Patient with prostate cancer and a physical activity |
| Physical Activity ProgramDuring the Physical Activity Program, patients will be supervised by peers and a clubs and sports associations labeled sport-health by Olympic and Sports Committee of the Loire Department. The peer will coach the patient once a week minimum for 3 months. | Other | STEP 3: Physical Activity Program |
Primary outcome
Physical Activity sessions performed
Time frame: At month 3
Analysis of the proportion (%) of Physical Activity sessions performed after 3 months of intervention.
6 secondary outcomes
physical activity via activity actigraph
Time frame: At month 3
sedentary lifestyle via activity actigraph
Time frame: At month 3
Patient's activation
Time frame: At month 3
brakes blocking intervention
Time frame: At month 3
levers favoring intervention
Time frame: At month 3
Peers mobilized
Time frame: At month 3
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 8 Feb 2023.
- 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.
David HUPIN, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interview, Adult Physical Activity Questionnaire (APAQ) and Activity actigraph in people with Cancer Prostate, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
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 7 inclusion and 5 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Physical Activity sessions performed (time frame: At month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.