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NCT Number: NCT07515326

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Léon Bérard

Lyon, 69373, France

Location status: Recruiting

Location contact

Béatrice Fervers, Pr

PRINCIPAL_INVESTIGATOR

Carmen Dupuis, PhD

CONTACT

[email protected]

0469856218

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KHEOPS program

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. acceptability

    Time frame: Post-intervention (week 22)

    participation rate (>70%) and dropout rate (<20%)

  2. 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%)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Carmen Dupuis, PhD

CONTACT

[email protected]

0469856218

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Cancéropôle Lyon Auvergne Rhône-Alpes

Registry information

Official study title

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

Acronym: CANDY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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