Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients (ACTI-PAIR2)

October 31, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

Title Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients - ACTI-PAIR 2 Multicenter, Randomized Stepped-wedge Study

Despite the recognized benefits of physical activity in tertiary prevention, 60-70% of prostate cancer patients are insufficiently active.

Yet 150 minutes of brisk walking per week (new WHO recommendations) is associated with a 29% reduction in cancer mortality and a 57% reduction in recurrence.

Increasing patients' adherence to regular physical activity appears to be a new challenge for personalized cancer care.

Personalized physical activity programmes (1) at home, (2) supported by health professionals, or (3) by peers have shown the effectiveness of regular physical activity.

However, these interventions last less than 6 months and do not allow for long-term sustainability of physical activity.

This study proposes to combine 3 interventions, which aim to initiate and maintain regular physical activity in prostate cancer patients:

  • 1-The realization of a personalized and realistic physical activity project via physical activity support devices (sport health centers)
  • 2-Coaching by a peer (a patient with the same disease who has reached the WHO recommendations for physical activity), who will provide motivational follow-up
  • 3-Support by health professionals (attending physician) through the prescription of physical activity.

The feasibility of ACTI-PAIR program has been demonstrated, the investigators now wish to evaluate it effectiveness.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Chambéry, France
        • Not yet recruiting
        • Activité Physique Adaptée - CDOS Savoie
        • Principal Investigator:
          • Fabrice DESCOMBES, MD
      • Chambéry, France
        • Not yet recruiting
        • CH Chambery
        • Principal Investigator:
          • Guillaume MORICEAU, MD
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Activité Physique Adaptée - DAHLIR 63
        • Principal Investigator:
          • Joris MARTIN, MD
      • Clermont-Ferrand, France
        • Not yet recruiting
        • CHU Clermont-Ferrand - ONCOLOGIE
        • Contact:
          • Aurore DOUGE
        • Sub-Investigator:
          • Rémi FILLATRE
        • Sub-Investigator:
          • Julien PINOT
        • Sub-Investigator:
          • Sébastien BAILLY Sébastien
      • Clermont-Ferrand, France
        • Not yet recruiting
        • CHU Clermont-Ferrand - Urologie
        • Contact:
          • Laurent GUY
        • Sub-Investigator:
          • Florian CERUTI, MD
        • Sub-Investigator:
          • Nicolas VEDRINE
        • Sub-Investigator:
          • Clémentine MILLET
        • Sub-Investigator:
          • Ludivine CAMBOU
        • Sub-Investigator:
          • Cyril CHARBONNEL
      • Grenoble, France
        • Not yet recruiting
        • Activité Physique Adaptée - CDOS Isère
        • Contact:
          • MD
        • Sub-Investigator:
          • Manon GIRARD, MD
        • Sub-Investigator:
          • Fanny BIZARD
        • Sub-Investigator:
          • Benjamin CASSEBRAS
        • Sub-Investigator:
          • Maëva MANUEL
        • Sub-Investigator:
          • Cécile GUIGUE
      • Grenoble, France
        • Not yet recruiting
        • CHU Grenoble - Urologie
        • Principal Investigator:
          • Jean-Luc DESCOTES, MD
        • Contact:
          • Jean-Luc DESCOTES, MD
      • Le Puy-en-Velay, France
        • Not yet recruiting
        • Activité Physique Adaptée - DAHLIR 43
        • Principal Investigator:
          • Anaïs CHARRA, MD
        • Contact:
          • Anaïs CHARRA, MD
      • Le Puy-en-Velay, France
        • Not yet recruiting
        • CH Le Puy en Velay
        • Principal Investigator:
          • Corinne BRUCHET, MD
        • Contact:
          • Corinne BRUCHET, MD
      • Lyon, France
        • Not yet recruiting
        • Activité Physique Adaptée - DAHLIR 69
        • Contact:
          • Julie Julie, MD
        • Principal Investigator:
          • Julie Julie, MD
      • Lyon, France
        • Not yet recruiting
        • CLB - Oncologie
        • Principal Investigator:
          • Cécile LAUDE, MD
        • Contact:
          • Cécile LAUDE, MD
      • Lyon, France
        • Not yet recruiting
        • CLB - Radiothérapie
        • Principal Investigator:
          • Sofiane HANAYA, MD
        • Contact:
          • Sofiane HANAYA, MD
      • Lyon, France
        • Not yet recruiting
        • HCL - CH Lyon Sud
        • Contact:
          • Alain RUFFION, MD
        • Principal Investigator:
          • Alain RUFFION, MD
      • Lyon, France, 69000
        • Not yet recruiting
        • HCL - Hôpital Edouard Herriot
        • Contact:
          • Marc COLOMBEL, PhD
        • Sub-Investigator:
          • Sébastien CROUZET
        • Sub-Investigator:
          • Ricardo CODAS DUARTE
        • Sub-Investigator:
          • Hakim FASSI-FEHRI
      • Privas, France
        • Not yet recruiting
        • Activité Physique Adaptée - CDOS Ardèche
        • Principal Investigator:
          • Jonathan BAZARD, MD
      • Roanne, France
        • Not yet recruiting
        • CH Roanne
        • Principal Investigator:
          • Lionel VINCENT, MD
        • Contact:
          • Lionel VINCENT, MD
      • Saint-Priest-en-Jarez, France, 42270
        • Not yet recruiting
        • Clinique du Parc
        • Contact:
          • Hocine HABCHI, MD
        • Sub-Investigator:
          • Amine MESSAOUD
      • Saint-Étienne, France
        • Recruiting
        • Hôpital privé de la Loire
        • Principal Investigator:
          • Stéphane LORIN, MD
        • Contact:
          • Stéphane LORIN, MD
        • Sub-Investigator:
          • Aline GUILLOT
        • Sub-Investigator:
          • Cécile VASSAL
      • Saint-Étienne, France
        • Not yet recruiting
        • Activité Physique Adaptée - DAPAP 42
        • Principal Investigator:
          • Maël GARROS, MD
        • Contact:
          • Maël GARROS, MD
      • Saint-Étienne, France
        • Recruiting
        • CHU Saint-Etienne - Oncologie
        • Principal Investigator:
          • Pierre CORNILLON, MD
        • Contact:
          • Pierre CORNILLON, MD
      • Saint-Étienne, France
        • Not yet recruiting
        • CHU Saint-Etienne - Radiothérapie
        • Principal Investigator:
          • Anne-Laure BAREILLE, MD
        • Contact:
          • Anne-Laure BAREILLE, MD
      • Valence, France
        • Not yet recruiting
        • Activité Physique Adaptée - CDOS Drôme
        • Principal Investigator:
          • Aline CARLIER, MD
      • Valence, France
        • Not yet recruiting
        • Hôpitaux Drôme Nord - Valence
        • Principal Investigator:
          • Thomas POLGUER, MD
      • Valence, France
        • Not yet recruiting
        • Radiologie Drôme-Ardèche - Valence
        • Principal Investigator:
          • Jean-Baptiste GUY, MD
        • Sub-Investigator:
          • Sébastien CLIPPE
        • Sub-Investigator:
          • Bertrand FLEURY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients:

  • Age ≥ 18 years
  • Diagnosed with prostate cancer for at least 1 year
  • PA practice < 150 minutes per week (considered inactive according to WHO)
  • Affiliated or entitled to a social security scheme
  • Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study

Exclusion Criteria:

For patients:

  • Undergoing treatment (except hormone therapy)
  • Significant comorbidities contraindicating the practice of physical activity: associated cardiac pathologies, respiratory pathologies, disabling joint pathologies
  • Deprived of liberty or under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acti-Pair program
  • Motivational support by the peer (a patient with the same pathology who meets the WHO recommendations for physical activity), who will provide motivational follow-up
  • The implementation of a personalized and realistic physical activity project for the patient via the physical activity support systems (sport health centers)
  • Support from health professionals (GP) via the prescription of physical activity and from adapted physical activity (APA) professionals
Behavioral: Acti-Pair program

Motivational support by the peer (a patient with the same pathology who meets the WHO recommendations for physical activity), who will provide motivational follow-up

  • The implementation of a personalized and realistic physical activity project for the patient via the physical activity support systems (sport health centers)
  • Support from health professionals (GP) via the prescription of physical activity and from adapted physical activity (APA) professionals
No Intervention: Usual care
The control group will be made up of patients followed up for prostate cancer and benefiting from usual care which consists of giving advice and recommendations for physical activity in consultation, aiming to make patients more active in their daily lives (=usual practice, physical activity to be carried out independently, at home).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures the intensity of physical activity)
Time Frame: Month: 12
via actimetry (Actigraph GT9x, Pensacola, Florida, USA) 12 months (+/- 1 month) after the patient's inclusion in the Acti-Pair program
Month: 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures intensity of physical activity)
Time Frame: Inclusion, 3, 6 and 12 months
via actimetry (Actigraph GT9x, Pensacola, Florida, USA) (at 3 and 6 months).
Inclusion, 3, 6 and 12 months
Objective measure of physical inactivity (in h/d)
Time Frame: Inclusion, 3, 6 and 12 months
via actimetry (Actigraph GT9x, Pensacola, Florida, USA)
Inclusion, 3, 6 and 12 months
Measurement of physical capacity: walking distance (meters)
Time Frame: Inclusion, 3, 6 and 12 months
via the 6-minute walk test (6MWT).
Inclusion, 3, 6 and 12 months
Measurement of muscle strength: biceps muscle strength (kg)
Time Frame: Inclusion, 3, 6 and 12 months
via the handgrip (JAMAR Hand Dynamometer, Nottingham, UK).
Inclusion, 3, 6 and 12 months
Level of fatigue assessed by measuring heart rate variability (SDNN and RMSSD in ms)
Time Frame: Inclusion, 3, 6 and 12 months
via heart rate monitor connected to an actimeter (Actigraph GT3x, Pensacola, Florida, USA) for 24 hours
Inclusion, 3, 6 and 12 months
Adoption of Acti-Pair program by physicians
Time Frame: through end of inclusion, an average of 30 months
Number of physicians including patients
through end of inclusion, an average of 30 months
Adoption of Acti-Pair program by peers
Time Frame: through end of inclusion, an average of 30 months
Number of peers recruited
through end of inclusion, an average of 30 months
Adoption of Acti-Pair program by Adapted Physical Activity (APA) professionals
Time Frame: through study completion, an average of 42 Months
Number of patients followed by APA professionals
through study completion, an average of 42 Months
Time dedicated by peers, Adapted Physical Activity (APA) professionals and health professionals to the Acti-Pair program
Time Frame: through study completion, an average of 42 Months
Number of hours spend to follow-up patient specifically for the Acti-Pair program by peers, Adapted Physical Activity (APA) professionals and health professionals
through study completion, an average of 42 Months
Assessment of the context:factors favoring and hindering implementation, achievement, adaptation and sustainability of the programme ; compliance with the programme ; social representations
Time Frame: Before and after the implementation of the intervention
Semi-structured interviews
Before and after the implementation of the intervention
Percentage of adherence to the intervention
Time Frame: 12 months
via the number of patients continuing the programme 12 months after initiation
12 months
Motivation to engage in physical activity for patients and peers
Time Frame: Inclusion, 3, 6 and 12 months
via the behavioural regulation in exercise questionnaire (BREQ-2). This questionnaire consists of 19 items includes 6 sub-scores of motivations : introjected regulation (3 items), external regulation (4 items), intrinsic regulation (4 items), integrated regulation, amotivation (4 items) and identified regulation (4 items) on a scale from 1 (Not at all true for me) to 5 (Absolutely true for me).
Inclusion, 3, 6 and 12 months
Cost per quality adjusted life year (QALY) gained through the intervention (quality adjusted life year)
Time Frame: 12 months
Quality of life data will be collected (e.g. quality of life using the EQ-5D-5L questionnaire, Appendix 3), transformed into utilities to calculate quality adjusted life year (QALY), and the number of patients continuing physical activity at 12 months. Cost data will be collected throughout the study, in each of the 8 departments involved. The analysis will be carried out from the payer's (health insurance) perspective. The time horizon will be that of the study (12 months), and therefore in accordance with French guidelines (HAS), no discount rate will be applied
12 months
Cost per patient continuing physical activity at 12 months through the intervention
Time Frame: 12 months
The costs will include : - direct medical costs : health professionals consultations, peer-to-peer, patient sessions with APA professionals - indirect costs of implementing the intervention: training, facility rental operating costs, investment in small equipment
12 months
Subjective measurement of physical activity (in Metabolic equivalent of task-h/week) and sedentary time (h/d)
Time Frame: Inclusion, 3, 6 and 12 months
Via the e-Adult Physical Activity Questionnaire (e-APAQ, EA SNA-EPIS, University of Jean Monnet, Saint-Etienne, France) e-Adult Physical Activity Questionnaire (e-APAQ) assesses the 5 categories of physical activity (work, travel, daily life, leisure and sport) and daily life, leisure and sport). The minimum value is 1 and the maximum value is 300. More the physical activity score is high, more the patient is active. This questionnaire authenticates the periods of sedentarity (at work, during travel and daily life, leisure and sport). The minimum value is 1 and the maximum value is 24. More the sedentarity score is high, more the patient is sedentary.
Inclusion, 3, 6 and 12 months
Level of fatigue
Time Frame: Inclusion, 3, 6 and 12 months
via the FACIT-F questionnaire (Functional Assessment of Chronic Illness Therapy - Fatigue Scale). This questionnaire asseses fatigue and it impacts. The score range is 0 to 160. More the score is higher, more the fatigue is high.
Inclusion, 3, 6 and 12 months
Health-related quality of life
Time Frame: Inclusion, 3, 6 and 12 months
via the EuroQol-5D questionnaire (EQ-5D-5L). The score range is -0.148 to 0.949. Mre the score is high, more the quality of life is good.
Inclusion, 3, 6 and 12 months
Alliance between the patient and the peer
Time Frame: 12 months

via the Working Alliance Inventory - short version (WAI-SR). This questionnaire measures three dimensions: bonding (development of a positive interpersonal attachment between the patient and the peer including mutual trust and respect), tasks (each partner's perception of the appropriateness and effectiveness of the care tasks, as well as tasks, as well as shared responsibility for their execution) and goals (understanding, validation and acceptance by both partners of the objectives of change in physical activity management).

Patients rate items on a 5-point Likert scale anchored at each end with 'rarely or never' (1) and 'always' (5). The Goal, Task and Bond domains each have scores ranging from 5 to 20. Higher scores indicate a better therapeutic alliance.
12 months
Patients, peers and professionals satisfaction
Time Frame: 12 months
Via a satisfaction questionnaire constructed for the Acti-Pair programme. The proposed responses are a likert scale ranging from Strongly Agree to Strongly Disagree. Each item will be described with a percentage of Likert scale for each response. More participants will fill out they have been strongly agree, more they will be satisfied.This questionnaire does not have a score.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France
Sport Health Center of Auvergne-Rhône Alpes
INSERM, SAINBIOSE U1059
INSERM, CIC1408
INSERM ECEVE 1123

Investigators

  • Principal Investigator: David HUPIN, MD PhD, CHU de Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20PH286
  • 2022-A01094-39 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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