Breast CancerDEFACTO2NCT05354882
Interventional Study on DEterminants and Factors of Physical ACtivity After Treatments in Oncology
A study testing Physical activity program in people with Breast Cancer and Colo-rectal Cancer, run by Université Sorbonne Paris Nord at 1 site in France.
Trial summary
Benefits of physical activity (PA) as supportive care in cancer have been widely demonstrated by the scientific community. However, survivors who have completed chemo-radio-immunotherapy treatments doesn't achieve PA recommendations on average. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Colo-rectal Cancer, Lung Cancer
- What is being tested?
- Physical activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2022to Dec 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years ≤ age < 75 years
- survivors of primary non-metastatic breast, lung, prostate or colorectal cancer (stage I, II or III and primary, second and relapse included)
- 3 weeks to 20 years post-treatment (surgery, chemotherapy, radiation therapy and/or immunotherapy) not including hormonal therapy
- Whose ability to participate in the APA intervention has been certified by a medical certificate issued by physician
- Availability and willingness to invest in the DEFACTO study during the program (3 months) and during the post-program follow-up (12 months)
- Participating, on average, in no more than 150 minutes of moderate physical activity or no more than 75 minutes of vigorous activity per week
Show all 13Show fewer
- Average at least 6 hours a day of sedentary behaviours
- Able to read, understand and complete questionnaires in French
- Able to use connected device (Vivosmart4®) and to perform simple operating actions (press a button, recharge the battery)
- possessing a smartphone which can download Garmin Connect application ®
- Able to walk unassisted
- French speaking and living in France
- having signed the consent form
Who cannot join
- Current evidence of metastatic disease
- Having an absolute contraindication by a physician to practice PA
- Using treatments that influence blood pressure, cardiotoxic drugs, painkillers (morphinics);
- Using cane or walking aid
- Deprived of liberty by judicial or administrative decision
- Person under guardianship or curatorship
- Pregnancy and/or lactating women
- Being diagnosed of any cardiac abnormalities
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Laboratoire Educations et Promotion de la Santé UR3412
Bobigny, 93017
Albane AA Aumaitre, PhD Student, 0033616883160, albane.au@gmail.com
Aude Marie AF Foucaut, 0033148387642, audemarie.foucaut@sorbonne-paris-nord.fr
About this study
Benefits of physical activity (PA) as supportive care in cancer have been widely demonstrated by the scientific community. However, survivors who have completed chemo-radio-immunotherapy treatments doesn't achieve PA recommendations on average. This reinforces the need to identify factors influencing PA level, and to propose a multilevel model (macro-, meso-, micro-level) to understand better what facilitates the adoption and maintenance of active behaviour and what hinders it. To date, there is no ecological model in France explaining this behaviour in the post-treatment phase of breast, colorectal, prostate, and lung cancers. From this initial model, we seek to design an educational and motivational intervention in PA.
Thus, the investigators propose to test the feasibility of implementing an individualized program to increase and maintain level of physical activity and to decrease sedentary behaviours in physically inactive cancer survivors. This program is based through and identification of barriers and facilitators of an active lifestyle among this population.
Read the detailed description
In 2008, 3 million French people had experienced cancer in the last 15 years, compared to 18 million in 2022. Post-treatment marks a break with the intensive care pathway. It frequently leads to changes in the lifestyle of these patients. During this period, behaviors conducive to maintaining their state of health remain important.
Among these behaviors, Physical Activity (PA) is an integral part and brings many post-treatment benefits. Despite the evidence of PA benefits in adult cancer survivors who have completed chemo-radio-immunotherapy treatments, the majority of those with good prognosis cancer are insufficiently active. Patient survival tends to increase by 20% thanks to scientific progress and the improvement of cancer management. At the same time, patients experience adverse effects for an extended period after cancer treatment. It would take an average of 10 to 15 years to note a decrease in the psychological, physical, professional, and socio-economic repercussions of cancer. These repercussions do not totally disappear over time. We have a particular interest in this post-treatment period, where the end of treatments marks a break within the "clinical pathway". The patient then joins the "care pathway" where he/she needs to have an autonomous management of his/her health behaviour.
The study of factors - clinical, psychological, cognitive, behavioural, social, or even linked to the clinical pathway and the geographical environment - involved in regular PA practice with breast, prostate, colorectal, or lung cancer survivors, would allow us an overview of what shapes a complex behaviour like PA.
In view of these needs to better understand and act on the complex behaviour of active lifestyle, the main objective of our research is to design, implement, and evaluate an individualised educational and motivational program, constructed from an explanatory ecological model. The educational and motivational program thus conceived will help in supporting good prognosis and physically inactive cancer survivors (breast, colorectal, prostate, or lung cancers) in initiation and maintenance of their PA.
Deployment of this interventional approach will provide more support to cancer survivors at the end of their treatment at a national level while considering the specificities of healthcare fields. To consider these variety, transferability criteria will be taken into account.
Thus, the investigators propose to test the feasibility of implementing an individualized program to increase and maintain level of physical activity and to decrease sedentary behaviours in physically inactive cancer survivors. This program is based through and identification of barriers and facilitators of an active lifestyle among this population.
- Conditions
- Breast Cancer, Colo-rectal Cancer, Lung Cancer, Prostate Cancer
- Being tested
- Physical activity program
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programBehavioural
Also called Motivational Interviewing, Discussion group, Adapted physical activity
The single group will access to the twelve-week DEFACTO program containing one adapted physical activity session, two discussion group sessions and several motivational interviewing
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Feasibility group. Single group (intervention group) will be given access to the DEFACTO intervention for twelve-weeks. Receives: Behavioral: Physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of physical activity (connected device)
Average daily steps, distance traveled, floors climbed, heart rate, cumulative duration of activities of moderate and vigorous intensities using VIVOSMART4® (Garmin)
Measured: One week before initiation of DEFACTO intervention, during the intervention and intervention at Month 3 and Month 6 and Month 12
Secondary outcomes (7)
Change of physical activity by the Global Physical Activity Questionnaire (GPAQ)
Change of physical activity evaluated by the GPAQ questionnaire, at baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Measured: At baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Assessment of life quality
Assessment by using the Short-Form 12 questionnaire (SF-12) Life quality scores calculation
Measured: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Assessment of Health literacy level
Assessment by using a single question concerning the need to resort refer to a health professional to understand health information
Measured: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Assessment of Knowledge about PA and its link with cancer
Assessment by using specific questions of the Cancer Exercise Stereotypes Scale
Measured: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Physical activity barriers
Assessment by using the "General determinants of PA" questionnaire. This tool examines 7 areas: 1) Lack of time; 2) Social influences; 3) Lack of energy; 4) Lack of willingness; 5) Fear of hurting yourself; 6) Lack of skill sets; 7) Lack of resources
Measured: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Transtheorical model's variables related to physical activity
Assessment by using the "Stages of change" questionnaire, "Processes of change (POC)" questionnaire, "decisional balance" questionnaire, and "self-efficacy" questionnaire.
Measured: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Motivation to physical activity pratice
Types of motivation based on self-determination theory, assessment by using the Motivation Scale for by Physical Activity for Health Purposes
Measured: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start29 Mar 2022
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
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 Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Sorbonne Paris Nord
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France, Garmin International, Stimulab
- Responsible party
- Principal investigator, Audemarie Foucaut, Université Sorbonne Paris Nord
- Investigators
- Aude-Marie AF Foucaut, Principal investigator, Université Sorbonne Paris Nord, Laboratoire Educations et Promotion de la Santé UR3412
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354882
- Sponsor's protocol ID
- 2021-A01570-41
- Acronym
- DEFACTO2
- Status last verified
- May 2023
- First submitted
- 11 Apr 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aumaitre A, Gagnayre R, Foucaut AM. Determinants and Factors of Physical Activity After Oncology Treatments (DEFACTO) in Metropolitan France: Protocol of a Mixed Methods Study and Intervention. JMIR Res Protoc. 2024 May 16;13:e52274. doi: 10.2196/52274.
PubMed 38753415
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study on DEterminants and Factors of Physical ACtivity After Treatments in Oncology
- ClinicalTrials.gov ID
- NCT05354882
- Acronym / sponsor ID
- DEFACTO2 / 2021-A01570-41
- Conditions
- Breast Cancer, Colo-rectal Cancer, Lung Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Université Sorbonne Paris NordUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France, Garmin International, Stimulab
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 May 2022 (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.
Benefits of physical activity (PA) as supportive care in cancer have been widely demonstrated by the scientific community. However, survivors who have completed chemo-radio-immunotherapy treatments doesn't achieve PA recommendations on average. This reinforces the need to identify factors influencing PA level, and to propose a multilevel model (macro-, meso-, micro-level) to understand better what facilitates the adoption and maintenance of active behaviour and what hinders it. To date, there is no ecological model in France explaining this behaviour in the post-treatment phase of breast, colorectal, prostate, and lung cancers. From this initial model, we seek to design an educational and motivational intervention in PA.
Thus, the investigators propose to test the feasibility of implementing an individualized program to increase and maintain level of physical activity and to decrease sedentary behaviours in physically inactive cancer survivors. This program is based through and identification of barriers and facilitators of an active lifestyle among this population.
Detailed description
In 2008, 3 million French people had experienced cancer in the last 15 years, compared to 18 million in 2022. Post-treatment marks a break with the intensive care pathway. It frequently leads to changes in the lifestyle of these patients. During this period, behaviors conducive to maintaining their state of health remain important.
Among these behaviors, Physical Activity (PA) is an integral part and brings many post-treatment benefits. Despite the evidence of PA benefits in adult cancer survivors who have completed chemo-radio-immunotherapy treatments, the majority of those with good prognosis cancer are insufficiently active. Patient survival tends to increase by 20% thanks to scientific progress and the improvement of cancer management. At the same time, patients experience adverse effects for an extended period after cancer treatment. It would take an average of 10 to 15 years to note a decrease in the psychological, physical, professional, and socio-economic repercussions of cancer. These repercussions do not totally disappear over time. We have a particular interest in this post-treatment period, where the end of treatments marks a break within the "clinical pathway". The patient then joins the "care pathway" where he/she needs to have an autonomous management of his/her health behaviour.
The study of factors - clinical, psychological, cognitive, behavioural, social, or even linked to the clinical pathway and the geographical environment - involved in regular PA practice with breast, prostate, colorectal, or lung cancer survivors, would allow us an overview of what shapes a complex behaviour like PA.
In view of these needs to better understand and act on the complex behaviour of active lifestyle, the main objective of our research is to design, implement, and evaluate an individualised educational and motivational program, constructed from an explanatory ecological model. The educational and motivational program thus conceived will help in supporting good prognosis and physically inactive cancer survivors (breast, colorectal, prostate, or lung cancers) in initiation and maintenance of their PA.
Deployment of this interventional approach will provide more support to cancer survivors at the end of their treatment at a national level while considering the specificities of healthcare fields. To consider these variety, transferability criteria will be taken into account.
Thus, the investigators propose to test the feasibility of implementing an individualized program to increase and maintain level of physical activity and to decrease sedentary behaviours in physically inactive cancer survivors. This program is based through and identification of barriers and facilitators of an active lifestyle among this population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Physical activity programFeasibility group. Single group (intervention group) will be given access to the DEFACTO intervention for twelve-weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years ≤ age < 75 years
- survivors of primary non-metastatic breast, lung, prostate or colorectal cancer (stage I, II or III and primary, second and relapse included)
- 3 weeks to 20 years post-treatment (surgery, chemotherapy, radiation therapy and/or immunotherapy) not including hormonal therapy
- Whose ability to participate in the APA intervention has been certified by a medical certificate issued by physician
- Availability and willingness to invest in the DEFACTO study during the program (3 months) and during the post-program follow-up (12 months)
Key exclusion criteria (8 listed)
- Current evidence of metastatic disease
- Having an absolute contraindication by a physician to practice PA
- Using treatments that influence blood pressure, cardiotoxic drugs, painkillers (morphinics);
- Using cane or walking aid
- Deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Physical activity programAlso: Motivational Interviewing, Discussion group, Adapted physical activityThe single group will access to the twelve-week DEFACTO program containing one adapted physical activity session, two discussion group sessions and several motivational interviewing | Behavioural | Intervention |
Primary outcome
Change of physical activity (connected device)
Time frame: One week before initiation of DEFACTO intervention, during the intervention and intervention at Month 3 and Month 6 and Month 12
Average daily steps, distance traveled, floors climbed, heart rate, cumulative duration of activities of moderate and vigorous intensities using VIVOSMART4® (Garmin)
7 secondary outcomes
Change of physical activity by the Global Physical Activity Questionnaire (GPAQ)
Time frame: At baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Assessment of life quality
Time frame: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Assessment of Health literacy level
Time frame: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Assessment of Knowledge about PA and its link with cancer
Time frame: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Physical activity barriers
Time frame: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Transtheorical model's variables related to physical activity
Time frame: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Motivation to physical activity pratice
Time frame: At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 38753415Aumaitre A, Gagnayre R, Foucaut AM. Determinants and Factors of Physical Activity After Oncology Treatments (DEFACTO) in Metropolitan France: Protocol of a Mixed Methods Study and Intervention. JMIR Res Protoc. 2024 May 16;13:e52274. doi: 10.2196/52274.
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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.
Aude-Marie AF Foucaut principal investigator
Université Sorbonne Paris Nord, Laboratoire Educations et Promotion de la Santé UR3412
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program in people with Breast Cancer and Colo-rectal Cancer, run by Université Sorbonne Paris Nord at 1 site 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 13 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 May 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albane AA Aumaitre, PhD student (0033616883160, albane.au@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of physical activity (connected device) (time frame: One week before initiation of DEFACTO intervention, during the intervention and intervention at Month 3 and Month 6 and Month 12). 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 NCT05354882, 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 9 May 2023.