Interventional Study on DEterminants and Factors of Physical ACtivity After Treatments in Oncology

NCT05354882 | Unknown

• 1 other identifier: 2021-A01570-41
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colo-rectal Cancer; Lung Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  At baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)

• Assessment of life quality

  At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)

• Assessment of Health literacy level

  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

  At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)

• Physical activity barriers

  At Baseline (at inclusion), and at the completion of intervention (12 weekends after the start of the intervention)

Other Outcomes (9)

• Weight

  At Baseline (at inclusion)

• Height

  At Baseline (at inclusion)

• Date of cancer diagnosis

  At Baseline (at inclusion)

Study Arms (1)

Intervention

EXPERIMENTAL

Feasibility group. Single group (intervention group) will be given access to the DEFACTO intervention for twelve-weeks.

Behavioral: Physical activity program

Interventions

Physical activity program BEHAVIORAL

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

Also known as: Motivational Interviewing, Discussion group, Adapted physical activity

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Sorbonne Paris Nord: lead
• Ligue contre le cancer, France: collaborator
• Garmin International: collaborator
• Stimulab: collaborator

Study Sites (1)

Laboratoire Educations et Promotion de la Santé UR3412

Bobigny, 93017, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 38753415 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Lung Neoplasms; Prostatic Neoplasms

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Aude-Marie AF Foucaut

  Université Sorbonne Paris Nord, Laboratoire Educations et Promotion de la Santé UR3412

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albane AA Aumaitre, PhD student

CONTACT

0033616883160; albane.au@gmail.com

Aude Marie AF Foucaut

CONTACT

0033148387642; audemarie.foucaut@sorbonne-paris-nord.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 2, 2022
• Study Start: March 29, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

FR (1)