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

March 30, 2026 updated by: Centre Leon Berard

Evolution of Psychological Determinants of Physical Activity and Cancer-related Psychological Symptoms in Patients Undergoing Treatment for Breast Cancer and Following a Physical Activity Program

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

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 Locations

  • France
      • Lyon, France, 69373
        • Recruiting
        • Centre Leon Berard
        • Contact:
        • Principal Investigator:
          • Béatrice Fervers, Pr

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with breast cancer, with a current treatment, followed at CLB

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
KHEOPS participants during breast cancer treatment
Behavioral: KHEOPS program
the KHEOPS program is an physical activity intervention, offered to patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score for each construct of multiprocess action control model (M-PAC)
Time Frame: 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)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acceptability
Time Frame: Post-intervention (week 22)
participation rate (>70%) and dropout rate (<20%)
Post-intervention (week 22)
completion rate of bi-weekly online questionnaires during the intervention
Time Frame: each monday (Monday week 1 to monday week 22), one friday per month (Friday week 1 to friday week 22)
(>80%)
each monday (Monday week 1 to monday week 22), one friday per month (Friday week 1 to friday week 22)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- depressive symptoms, by Patient Health Questionnaire
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- anxiety symptoms, by Generalized Anxiety Disorder
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- perceived pain, by Brief Pain Inventory
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- perceived fatigue, by Multidimensional Fatigue Inventory Short Form or Daily Fatigue Cancer Scale
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- sense of self-efficacy, by Perceived Capacity over Physical Activity questionnaire
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- sense of self-efficacy related to coping with barriers, by Coping self-efficacy Scale
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- affective and instrumental attitudes, by Attitude toward PA - affective attitude and instrumental attitude
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- habit, by Self-Report Behavioral Automaticity Index
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- identity, by Athletic Identity Measurement Scale
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- planification, by self-reported planning for PA Scale
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
cancer-related psychological symptoms during and after the program
Time Frame: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)
- therapeutic alliance questionnaire, by Therapeutic alliance questionnaire
Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)

Collaborators and Investigators

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

Sponsor

Centre Leon Berard

Collaborators

Cancéropôle Lyon Auvergne Rhône-Alpes

Investigators

  • Study Director: Olivia Perol, PhD, Département Prévention Cancer Environnement, Centre Léon Bérard
  • Principal Investigator: Béatrice Fervers, Pr, Département Prévention Cancer Environnement, Centre Léon Bérard
  • Study Director: Johan Caudroit, PhD, Université Lyon1

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)

December 18, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CANDY (ET 24-127)
  • 2024-A01075-42 (Other Identifier: ID RCB)

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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