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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Leon Berard

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • KHEOPS program

    Behavioral

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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: KHEOPS participants during breast cancer treatment1 intervention

Trial outcomes

Primary outcomes

1

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)

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)

Secondary outcomes

1

acceptability

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

Time frame
Post-intervention (week 22)
2

completion rate of bi-weekly online questionnaires during the intervention

(\>80%)

Time frame
each monday (Monday week 1 to monday week 22), one friday per month (Friday week 1 to friday week 22)
3

cancer-related psychological symptoms during and after the program

\- depressive symptoms, by Patient Health Questionnaire

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)
4

cancer-related psychological symptoms during and after the program

\- anxiety symptoms, by Generalized Anxiety Disorder

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Leon Berard

Lead sponsor

Cancéropôle Lyon Auvergne Rhône-Alpes

Collaborator