Breast Cancer, Colorectal Cancer, Gastric Adenocarcinoma, Ovarian Adenocarcinoma, Pancreatic Cancer
Conditions
Keywords
adapted physical activity, fatigue, completed adjuvant systemic chemotherapy for cancer
Brief summary
A single-center, randomized (1:1) open-label, prospective, stratified study with two parallel arms, designed to evaluate adherence to the adapted physical activity (APA) program for patients participating in an APA program and to compare changes in fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program.
Interventions
OTHERAPA program
patient will benefit of an activity monitored by a wtach and an APA program during 3 months
Sponsors
Centre Antoine Lacassagne
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 to 75 years old, 2. Histologically proven non-metastatic adenocarcinoma of breast, colorectal, ovarian, pancreatic, biliary, or gastric origin, 3. Adjuvant chemotherapy completed less than 3 months ago (excluding hormone therapy), 4. PS 0 or 1 according to the World Health Organization (WHO) scale, 5. No recurrence since the end of adjuvant chemotherapy, 6. Patient who has voluntarily agreed to participate in the study and sign the written informed consent form, 7. Patient affiliated with a Social Security scheme.
Exclusion criteria
1. New cancer treatment planned (excluding hormone therapy), 2. Patient who has received adjuvant immunotherapy, 3. Cardiological contraindication to the program 4. Decompensated or unstable chronic conditions 5. Severe malnutrition 6. Rheumatological unfitness as determined by the oncologist, 7. Chronic respiratory failure requiring long-term O2 therapy 8. Diabetes with plantar ulceration 9. Progressive or chronic non-healing bedsore/wound 10. Recent unhealed fracture 11. Patient participating in another interventional clinical study at the time of signing the informed consent form. 12. Vulnerable persons as defined in Articles L1121-5 to -8
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adherence to the adapted physical activity (APA) program by the percentage of patients who completed 75% of the weekly sessions of the APA program with a heart rate (HR) between 40 and 60% of their reserve HR for 20-40 minutes. | 3 months | Assessing adherence to the adapted physical activity (APA) program for patients participating in an APA program |
| evolution of fatigue in patients who are participating in an APA program by the difference in Multidimensional Fatigue Inventory (MFI-20) questionnaire scores (20 items) between the first and last visit at 3 months. | 3 months | Compare the evolution of fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program. Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0;100] | 3 months | Compare changes in patients' quality of life following the APA program versus standard follow-up. QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level. |
| evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100] | 6 months | Compare changes in patients' quality of life following the APA program versus standard follow-up. QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level. |
| Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126] | 3 months | Compare the motivation for physical activity among patients following the APA program compared to standard follow-up. The EMAPS questionnaire comprise six motivational concepts highlighted by self-determination theory (intrinsic, integrated, identified, introjected, and external motivation). A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). |
| Compare the evolution of fatigue with MFI-20 questionnaire scores (20 items) between the first and last visit at 6 months, in patients who followed the APA program versus standard follow-up | 6 months | Compare the difference in MFI-20 fatigue scores between the first visit and the visits at 6 months. Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue. |
| Compare the evolution of fatigue with MFI-20 questionnaire scores (20 items) between the first and last visit at 12 months, in patients who followed the APA program versus standard follow-up | 12 months | Compare the difference in MFI-20 fatigue scores between the first visit and the visits at 12 months. Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue. |
Countries
France
Contacts
CONTACTLudovic EVESQUE, Doctor
Outcome results
None listed