Interventional Study on DEterminants and Factors of Physical ACtivity After Treatments in Oncology (DEFACTO2)
Primary Purpose
Breast Cancer, Colo-rectal Cancer, Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity program
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Laboratoire Educations et Promotion de la Santé UR3412Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Feasibility group. Single group (intervention group) will be given access to the DEFACTO intervention for twelve-weeks.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Assessment of life quality
Assessment by using the Short-Form 12 questionnaire (SF-12) Life quality scores calculation
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
Assessment of Knowledge about PA and its link with cancer
Assessment by using specific questions of the Cancer Exercise Stereotypes Scale
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
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.
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
Full Information
NCT ID
NCT05354882
First Posted
April 11, 2022
Last Updated
May 8, 2023
Sponsor
Université Sorbonne Paris Nord
Collaborators
Ligue contre le cancer, France, Garmin International, Stimulab
1. Study Identification
Unique Protocol Identification Number
NCT05354882
Brief Title
Interventional Study on DEterminants and Factors of Physical ACtivity After Treatments in Oncology
Acronym
DEFACTO2
Official Title
Interventional Study on DEterminants and Factors of Physical ACtivity After Treatments in Oncology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Sorbonne Paris Nord
Collaborators
Ligue contre le cancer, France, Garmin International, Stimulab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colo-rectal Cancer, Lung Cancer, Prostate Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Feasibility group. Single group (intervention group) will be given access to the DEFACTO intervention for twelve-weeks.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity program
Other Intervention Name(s)
Motivational Interviewing, Discussion group, Adapted physical activity
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of physical activity (connected device)
Description
Average daily steps, distance traveled, floors climbed, heart rate, cumulative duration of activities of moderate and vigorous intensities using VIVOSMART4® (Garmin)
Time Frame
One week before initiation of DEFACTO intervention, during the intervention and intervention at Month 3 and Month 6 and Month 12
Secondary Outcome Measure Information:
Title
Change of physical activity by the Global Physical Activity Questionnaire (GPAQ)
Description
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)
Time Frame
At baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Title
Assessment of life quality
Description
Assessment by using the Short-Form 12 questionnaire (SF-12) Life quality scores calculation
Time Frame
At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Title
Assessment of Health literacy level
Description
Assessment by using a single question concerning the need to resort refer to a health professional to understand health information
Time Frame
At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Title
Assessment of Knowledge about PA and its link with cancer
Description
Assessment by using specific questions of the Cancer Exercise Stereotypes Scale
Time Frame
At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Title
Physical activity barriers
Description
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
Time Frame
At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Title
Transtheorical model's variables related to physical activity
Description
Assessment by using the "Stages of change" questionnaire, "Processes of change (POC)" questionnaire, "decisional balance" questionnaire, and "self-efficacy" questionnaire.
Time Frame
At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Title
Motivation to physical activity pratice
Description
Types of motivation based on self-determination theory, assessment by using the Motivation Scale for by Physical Activity for Health Purposes
Time Frame
At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)
Other Pre-specified Outcome Measures:
Title
Weight
Description
in kilograms (weight and height will be combined to report BMI in kg/m^2)
Time Frame
At Baseline (at inclusion)
Title
Height
Description
in centimeters (height and weight will be combined to report BMI in kg/m^2)
Time Frame
At Baseline (at inclusion)
Title
Date of cancer diagnosis
Description
(month/year)
Time Frame
At Baseline (at inclusion)
Title
Tumor location and cancer recurrence or second primary cancer
Description
(breast, colorectal, lung or prostate)
Time Frame
At Baseline (at inclusion)
Title
Stage of cancer
Description
(I, /II, or /III)
Time Frame
At Baseline (at inclusion)
Title
Type of treatment
Description
(chemotherapy, radiation therapy, immunotherapy, hormonotherapy)
Time Frame
At Baseline (at inclusion)
Title
Clinical data
Description
Body Mass Index (BMI, kg/m^2), date of diagnosis (month/year), tumour location (breast, colorectal, lung or prostate), stage of cancer (I, /II, or /III), cancer recurrence or second primary cancer, type of treatment, date on the treatment end (chemotherapy, radiation therapy, immunotherapy, hormonotherapy + month/year); (close-ended questions)
Time Frame
At Baseline (at inclusion)
Title
Date on the treatment end
Description
(month/year)
Time Frame
At Baseline (at inclusion)
Title
Socio-demographic variables
Description
Educational qualifications, economic class-status, current professional situation, household type, habitat type, geographical environment (rural or /urban); (close-ended questions)
Time Frame
At Baseline (at inclusion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albane AA Aumaitre, PhD student
Phone
0033616883160
Email
albane.au@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aude Marie AF Foucaut
Phone
0033148387642
Email
audemarie.foucaut@sorbonne-paris-nord.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aude-Marie AF Foucaut
Organizational Affiliation
Université Sorbonne Paris Nord, Laboratoire Educations et Promotion de la Santé UR3412
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoire Educations et Promotion de la Santé UR3412
City
Bobigny
ZIP/Postal Code
93017
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albane AA Aumaitre, PhD Student
Phone
0033616883160
Email
albane.au@gmail.com
First Name & Middle Initial & Last Name & Degree
Aude Marie AF Foucaut
Phone
0033148387642
Email
audemarie.foucaut@sorbonne-paris-nord.fr
12. IPD Sharing Statement
Learn more about this trial
Interventional Study on DEterminants and Factors of Physical ACtivity After Treatments in Oncology
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