Breast CancerCANDYNCT07515326
Evolution of Clinical and Motivational Constructs During the Physical Activity Program KHEOPS, Already Offered to Patients at the Centre Léon Bérard
An observational study of Breast Cancer, run by Centre Leon Berard at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- KHEOPS program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer, with a current treatment, followed at CLB
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Léon Bérard
Lyon, 69373
Carmen Dupuis, PhD, 0469856218, carmen.dupuis@lyon.unicancer.fr
Béatrice Fervers, Pr
About this study
Official 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
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- KHEOPS program
- Keywords
- Breast cancer, physical activty, KHEOPS program
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHEOPS programBehavioural
the KHEOPS program is an physical activity intervention, offered to patients
| Study group | Role | What they receive |
|---|---|---|
| KHEOPS participants during breast cancer treatment | Not described Receives: Behavioral: KHEOPS program |
What is being measured
The primary outcome is the main question the study is designed to answer.
score for each construct of multiprocess action control model (M-PAC)
- 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)
Measured: 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 outcomes (13)
acceptability
participation rate (>70%) and dropout rate (<20%)
Measured: Post-intervention (week 22)
completion rate of bi-weekly online questionnaires during the intervention
(>80%)
Measured: 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
- depressive symptoms, by Patient Health Questionnaire
Measured: 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
- anxiety symptoms, by Generalized Anxiety Disorder
Measured: 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
- perceived pain, by Brief Pain Inventory
Measured: 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
- perceived fatigue, by Multidimensional Fatigue Inventory Short Form or Daily Fatigue Cancer Scale
Measured: 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
- sense of self-efficacy, by Perceived Capacity over Physical Activity questionnaire
Measured: 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
- sense of self-efficacy related to coping with barriers, by Coping self-efficacy Scale
Measured: 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
- affective and instrumental attitudes, by Attitude toward PA - affective attitude and instrumental attitude
Measured: 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
- habit, by Self-Report Behavioral Automaticity Index
Measured: 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
- identity, by Athletic Identity Measurement Scale
Measured: 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
- planification, by self-reported planning for PA Scale
Measured: 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
- therapeutic alliance questionnaire, by Therapeutic alliance questionnaire
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start18 Dec 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Cancéropôle Lyon Auvergne Rhône-Alpes
- Responsible party
- Sponsor
- Investigators
- Olivia Perol, PhD, Study director, Département Prévention Cancer Environnement, Centre Léon BérardBéatrice Fervers, Pr, Principal investigator, Département Prévention Cancer Environnement, Centre Léon BérardJohan Caudroit, PhD, Study director, Université Lyon1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515326
- Sponsor's protocol ID
- CANDY (ET 24-127)
- Other IDs
- 2024-A01075-42
- Acronym
- CANDY
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07515326
- Acronym / sponsor ID
- CANDY / CANDY (ET 24-127)
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, physical activty, KHEOPS program
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Cancéropôle Lyon Auvergne Rhône-Alpes
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KHEOPS participants during breast cancer treatment | – | Behavioral: KHEOPS program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer, with a current treatment, followed at CLB
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KHEOPS programthe KHEOPS program is an physical activity intervention, offered to patients | Behavioural | KHEOPS participants during breast cancer treatment |
Primary outcome
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)
13 secondary outcomes
acceptability
Time frame: 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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivia Perol, PhD study director
Département Prévention Cancer Environnement, Centre Léon Bérard
Béatrice Fervers, Pr principal investigator
Département Prévention Cancer Environnement, Centre Léon Bérard
Johan Caudroit, PhD study director
Université Lyon1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen Dupuis, PhD (0469856218, carmen.dupuisl@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.