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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Behavioral: Acti-Pair program

Study type

Interventional

Funder types

Other

Identifiers

NCT05739565
20PH286
2022-A01094-39 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

850 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

850 participants in 2 patient groups

Acti-Pair program
Experimental group
Description:
* 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
Treatment:
Behavioral: Acti-Pair program
Usual care
No Intervention group
Description:
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).

Trial contacts and locations

25

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Central trial contact

Amandine BAUDOT, CRA; HUPIN DAVID, MD

Data sourced from clinicaltrials.gov

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