A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study
Abstract Background Up to 70% of breast cancer patients report symptoms of insomnia during and after treatment. Despite the ubiquity of insomnia symptoms, they are under-screened, under-diagnosed and poorly managed in breast cancer patients. Sleep medications treat symptoms but are ineffective to cu...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-05-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12885-023-10902-6 |
| _version_ | 1797822801408688128 |
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| author | Chloé Drozd Elsa Curtit Quentin Jacquinot Charlène Marquine Laura Mansi Loïc Chaigneau Erion Dobi Julien Viot Guillaume Meynard Marie-Justine Paillard Morgan Goujon Pauline Roux Dewi Vernerey Valérie Gillet Hubert Bourdin Silvio Galli Nathalie Meneveau Fabienne Mougin |
| author_facet | Chloé Drozd Elsa Curtit Quentin Jacquinot Charlène Marquine Laura Mansi Loïc Chaigneau Erion Dobi Julien Viot Guillaume Meynard Marie-Justine Paillard Morgan Goujon Pauline Roux Dewi Vernerey Valérie Gillet Hubert Bourdin Silvio Galli Nathalie Meneveau Fabienne Mougin |
| author_sort | Chloé Drozd |
| collection | DOAJ |
| description | Abstract Background Up to 70% of breast cancer patients report symptoms of insomnia during and after treatment. Despite the ubiquity of insomnia symptoms, they are under-screened, under-diagnosed and poorly managed in breast cancer patients. Sleep medications treat symptoms but are ineffective to cure insomnia. Other approaches such as cognitive behavioral therapy for insomnia, relaxation through yoga and mindfulness are often not available for patients and are complex to implement. An aerobic exercise program could be a promising treatment and a feasible option for insomnia management in breast cancer patients, but few studies have investigated the effects of such a program on insomnia. Methods This multicenter, randomized clinical trial evaluate the effectiveness of a moderate to high intensity physical activity program (45 min, 3 times per week), lasting 12 weeks, in minimizing insomnia, sleep disturbances, anxiety/depression, fatigue, and pain, and in enhancing cardiorespiratory fitness. Patients with breast cancer be recruited from six hospitals in France and randomly allocated to either the “training” or the “control” group. Baseline assessments include questionnaires [Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index questionnaire (PSQI), Hospital Anxiety Depression Scale (HADS), Epworth Sleepiness Scale (ESS)], home polysomnography (PSG), and 7-day actigraphy coupled with completion of a sleep diary. Assessments are repeated at the end of training program and at six-month follow-up. Discussion This clinical trial will provide additional evidence regarding the effectiveness of physical exercise in minimizing insomnia during and after chemotherapy. If shown to be effective, exercise intervention programs will be welcome addition to the standard program of care offered to patients with breast cancer receiving chemotherapy. Trial registration : National Clinical Trials Number (NCT04867096). |
| first_indexed | 2024-03-13T10:14:30Z |
| format | Article |
| id | doaj.art-5473dfa5db4749b08b82dda664fb277d |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-03-13T10:14:30Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-5473dfa5db4749b08b82dda664fb277d2023-05-21T11:18:45ZengBMCBMC Cancer1471-24072023-05-0123111210.1186/s12885-023-10902-6A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN studyChloé Drozd0Elsa Curtit1Quentin Jacquinot2Charlène Marquine3Laura Mansi4Loïc Chaigneau5Erion Dobi6Julien Viot7Guillaume Meynard8Marie-Justine Paillard9Morgan Goujon10Pauline Roux11Dewi Vernerey12Valérie Gillet13Hubert Bourdin14Silvio Galli15Nathalie Meneveau16Fabienne Mougin17Sports Science Faculty, University of Franche-ComtéDepartment of Medical Oncology, University HospitalResearch Unit EA3920, University of Franche-ComtéSports Science Faculty, University of Franche-ComtéDepartment of Medical Oncology, University HospitalDepartment of Medical Oncology, University HospitalDepartment of Medical Oncology, University HospitalDepartment of Medical Oncology, University HospitalDepartment of Medical Oncology, University HospitalDepartment of Medical Oncology, University HospitalDepartment of Medical Oncology, University HospitalDepartment of Physiology-Functional Explorations, University HospitalMethodology and Quality of Life Unit, UMR 1098, University HospitalSleep Medicine CenterResearch Unit EA481, Unit of Sleep Disorder, University of Franche-ComtéDepartment of Neurology, University HospitalDepartment of Medical Oncology, University HospitalSports Science Faculty, University of Franche-ComtéAbstract Background Up to 70% of breast cancer patients report symptoms of insomnia during and after treatment. Despite the ubiquity of insomnia symptoms, they are under-screened, under-diagnosed and poorly managed in breast cancer patients. Sleep medications treat symptoms but are ineffective to cure insomnia. Other approaches such as cognitive behavioral therapy for insomnia, relaxation through yoga and mindfulness are often not available for patients and are complex to implement. An aerobic exercise program could be a promising treatment and a feasible option for insomnia management in breast cancer patients, but few studies have investigated the effects of such a program on insomnia. Methods This multicenter, randomized clinical trial evaluate the effectiveness of a moderate to high intensity physical activity program (45 min, 3 times per week), lasting 12 weeks, in minimizing insomnia, sleep disturbances, anxiety/depression, fatigue, and pain, and in enhancing cardiorespiratory fitness. Patients with breast cancer be recruited from six hospitals in France and randomly allocated to either the “training” or the “control” group. Baseline assessments include questionnaires [Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index questionnaire (PSQI), Hospital Anxiety Depression Scale (HADS), Epworth Sleepiness Scale (ESS)], home polysomnography (PSG), and 7-day actigraphy coupled with completion of a sleep diary. Assessments are repeated at the end of training program and at six-month follow-up. Discussion This clinical trial will provide additional evidence regarding the effectiveness of physical exercise in minimizing insomnia during and after chemotherapy. If shown to be effective, exercise intervention programs will be welcome addition to the standard program of care offered to patients with breast cancer receiving chemotherapy. Trial registration : National Clinical Trials Number (NCT04867096).https://doi.org/10.1186/s12885-023-10902-6Breast cancerInsomniaSleepPolysomnographyFatigueExercise |
| spellingShingle | Chloé Drozd Elsa Curtit Quentin Jacquinot Charlène Marquine Laura Mansi Loïc Chaigneau Erion Dobi Julien Viot Guillaume Meynard Marie-Justine Paillard Morgan Goujon Pauline Roux Dewi Vernerey Valérie Gillet Hubert Bourdin Silvio Galli Nathalie Meneveau Fabienne Mougin A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study BMC Cancer Breast cancer Insomnia Sleep Polysomnography Fatigue Exercise |
| title | A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study |
| title_full | A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study |
| title_fullStr | A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study |
| title_full_unstemmed | A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study |
| title_short | A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study |
| title_sort | randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non metastatic breast cancer undergoing chemotherapy design of the fatsomcan study |
| topic | Breast cancer Insomnia Sleep Polysomnography Fatigue Exercise |
| url | https://doi.org/10.1186/s12885-023-10902-6 |
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