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Clinical Trials in France / NCT07515326
Recruiting Observational

Evolution of Clinical and Motivational Constructs During the Physical Activity Program KHEOPS, Already Offered to Patients at the Centre Léon Bérard

NCT07515326 · tracked via the Priya Life Science France tracker
Sponsor
Centre Leon Berard
Phase
Observational
Started
2024-12-18
Last updated
2026-04-07

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

KHEOPS program

KHEOPS program: the KHEOPS program is an physical activity intervention, offered to patients

Study summary

CANDY is a single-center, prospective study designed to observe the evolution of clinical and motivational constructs during the APA program KHEOPS program, already offered to patients at the Centre Léon Bérard (CLB).

The main aim of the CANDY study is to observe the evolution of psychological constructs derived from M-PAC during a 13-week KHEOPS APA program in women undergoing treatment for breast cancer.

Secondary objectives are:

* to examine the feasibility of psychological measures and participation in the KHEOPS program
* to observe cancer-related psychological symptoms during the KHEOPS program and to investigate the links between the temporal evolution of psychological factors (clinical and motivational) and adherence to the KHEOPS program, as well as the level of post-program PA during and after the KHEOPS program in patients followed at the CLB.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Woman aged ≥ 18 years * Diagnosed with non-metastatic breast cancer * Undergoing treatment or after surgery * Participating in the CLB KHEOPS program, either face-to-face or distance learning * Have a smartphone, computer or tablet to answer the 2 weekly online weekly online questionnaires and to follow APA sessions for patients following the patients following the KHEOPS program remotely * Having received a study information note and having made a declaration of non-opposition * Affiliated with a social security scheme * Able to read, write and understand French Exclusion Criteria: * Unable to be followed for medical, social, family, geographical or psychological reasons, for the duration of the study. * Have difficulty completing a questionnaire alone * Deprived of liberty by judicial or administrative decision, or adults protected by law * Concurrently participating in another PA study

Primary outcome measure(s)

  • score for each construct of multiprocess action control model (M-PAC) — Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), one friday per month (Friday week 1 to Friday week 22), post-intervention + 1 month (Week 26)
    * The score for each M-PAC construct oriented toward participation in PA sessions throughout the KHEOPS program; * The score for each M-PAC construct oriented towards PA practice after the KHEOPS program program during the intervention. Constructs of M-PAC : * Attitude towards Physical Activity - Affective Attitude (7-point Likert Scale, extremely disagree to extremely agree) * Attitude towards Physical Activity - Instrumental Attitude (7-point Likert Scale, extremely disagree to extremely agree) * Perceived Capability over Physical Activity (5-point Likert Scale, strongly disagree to strongly agree) * Perceived Opportunity for Physical Activity (5-point Likert Scale, strongly disagree to strongly agree)

Trial sites (1)

FacilityCityRegionStatus
Centre Léon Bérard Lyon France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07515326 on ClinicalTrials.gov ↗ ← All trials in France