Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT04001751
Status:
COMPLETED
Last Update Posted:
2025-05-18
First Post:
2019-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study: Yoga Educational Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2019-06-07', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patient compliance to the educational yoga program', 'timeFrame': '12 weeks', 'description': 'Compliance will be posittive if 70% of daily sessions at home and 4 sessions out of the 6 therapeutic educational (TEP) sessions delivered in the center by a physical therapist are realised'}], 'secondaryOutcomes': [{'measure': "the patients' satisfaction towards the program", 'timeFrame': '12 weeks', 'description': 'Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)'}, {'measure': 'the induced self-competency feeling', 'timeFrame': '12 weeks', 'description': 'self-competency feeling induced will be assessed using the GSES (General Self Efficacy-Schwarzer) questionnaire (10 questions - scale 1- not at all true to 4-totally true)'}, {'measure': 'To assess quality of life by Quality of Life Questionnaire', 'timeFrame': '12 weeks', 'description': 'Quality of life will be measured by EORTC QLQ-C30 (Quality of Life Questionnaire)'}, {'measure': 'To assess quality of life by Quality of Life Questionnaire specify for Breast Cancer', 'timeFrame': '12 weeks', 'description': 'Quality of life will be measured by EORTC QLQ-Br23 (Quality of Life Questionnaire specify for Breast Cancer)'}, {'measure': 'To assess fatigue and stress', 'timeFrame': '12 weeks', 'description': 'Fatigue and stress will be assessed using a Visual Analogous Scale (VAS) (0: no fatigue or no stress to 10 - maximum fatigue or stress)'}, {'measure': 'Anxiety and depression prevalence', 'timeFrame': '12 weeks', 'description': 'Anxiety and depression will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire (7 questions about Anxiety and 7 questions about Depression)'}, {'measure': 'Osteoarticular pain', 'timeFrame': '12 weeks', 'description': 'osteoarticular pain will be assessed using a Visual Analogous scale (0: no pain to 10: maximum pain)'}, {'measure': 'Forward-flexion flexibility', 'timeFrame': '12 weeks', 'description': 'Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler.'}, {'measure': 'Respiratory capacity', 'timeFrame': '12 weeks', 'description': 'Respiratory capacity will be measured with a spirometer'}, {'measure': 'Compliance to hormonotherapy treatment', 'timeFrame': '12 weeks', 'description': 'Taking hormonotherapy treatments will be reported in a log-book by the patients.'}, {'measure': 'Patient enrolment rate', 'timeFrame': 'at baseline', 'description': 'The patient enrolment rate will be estimated (i.e. the proportion of patients giving their consent to participate in the study among eligible screened patients).'}, {'measure': 'Reasons of non-participation to the study.', 'timeFrame': 'at baseline', 'description': 'The reason of non-participation to the study (difficulty of coming, not concerning by the project, not interesting by the project, fatigue, other) will be reported by the patient to the doctor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'hormonotherapy', 'osteoarticular pain', 'yoga', 'therapeutic patient education'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24816806', 'type': 'BACKGROUND', 'citation': 'Lintermans A, Van Asten K, Wildiers H, Laenen A, Paridaens R, Weltens C, Verhaeghe J, Vanderschueren D, Smeets A, Van Limbergen E, Leunen K, Christiaens MR, Neven P. A prospective assessment of musculoskeletal toxicity and loss of grip strength in breast cancer patients receiving adjuvant aromatase inhibitors and tamoxifen, and relation with BMI. Breast Cancer Res Treat. 2014 Jul;146(1):109-16. doi: 10.1007/s10549-014-2986-7. Epub 2014 May 11.'}, {'pmid': '25814054', 'type': 'BACKGROUND', 'citation': 'Peppone LJ, Janelsins MC, Kamen C, Mohile SG, Sprod LK, Gewandter JS, Kirshner JJ, Gaur R, Ruzich J, Esparaz BT, Mustian KM. The effect of YOCAS(c)(R) yoga for musculoskeletal symptoms among breast cancer survivors on hormonal therapy. Breast Cancer Res Treat. 2015 Apr;150(3):597-604. doi: 10.1007/s10549-015-3351-1. Epub 2015 Mar 27.'}, {'pmid': '17761973', 'type': 'BACKGROUND', 'citation': 'Crew KD, Greenlee H, Capodice J, Raptis G, Brafman L, Fuentes D, Sierra A, Hershman DL. Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol. 2007 Sep 1;25(25):3877-83. doi: 10.1200/JCO.2007.10.7573.'}, {'pmid': '25749602', 'type': 'BACKGROUND', 'citation': 'Greenlee H, Balneaves LG, Carlson LE, Cohen M, Deng G, Hershman D, Mumber M, Perlmutter J, Seely D, Sen A, Zick SM, Tripathy D; Society for Integrative Oncology. Clinical practice guidelines on the use of integrative therapies as supportive care in patients treated for breast cancer. J Natl Cancer Inst Monogr. 2014 Nov;2014(50):346-58. doi: 10.1093/jncimonographs/lgu041.'}, {'pmid': '26556210', 'type': 'BACKGROUND', 'citation': 'Lombard JM, Zdenkowski N, Wells K, Beckmore C, Reaby L, Forbes JF, Chirgwin J. Aromatase inhibitor induced musculoskeletal syndrome: a significant problem with limited treatment options. Support Care Cancer. 2016 May;24(5):2139-2146. doi: 10.1007/s00520-015-3001-5. Epub 2015 Nov 10.'}, {'pmid': '34939444', 'type': 'DERIVED', 'citation': 'Faravel K, Huteau ME, Jarlier M, de Forges H, Meignant L, Senesse P, Norton J, Jacot W, Stoebner A. Importance of Patient Education for At-home Yoga Practice in Women With Hormonal Therapy-induced Pain During Adjuvant Breast Cancer Treatment: A Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211063791. doi: 10.1177/15347354211063791.'}]}, 'descriptionModule': {'briefSummary': "As much as 45 to 60% of patients treated with hormonotherapy (HT) for breast cancer (BC) suffer from osteoarticular pain during treatment. Secondary effects have become a real issue because of their consequences on the patients' quality of life, but also on treatment efficacy and survival when they induce dose reduction or premature withdrawal of treatment.\n\nAdditional medicines (acupuncture, hypnosis, yoga) have become more and more popular these last years. 48 to 80% of patients with BC eventually choose them. A review comparing efficacy of various therapies to decrease osteoarticular pain concludes to a highest efficacy of anti-inflammatory treatments, paracetamol and yoga.\n\nWith this project, the investigators will assess the feasibility of a therapeutic yoga program with home practice for patients with breast cancer treated with hormonotherapy. The investigators will measure adhesion of the patients to perform yoga postures in an autonomous manner. Our study will also allow collection of data on the effect of such a program on quality of life, in view of setting-up an intervention study.", 'detailedDescription': "Numerous initiatives have started in France, often associative. It is essential to evaluate in a rigorous manner, these therapies before making them part of the patient's care pathway.\n\nYoga has shown a real benefit in terms of pain reduction in patients with BC treated with HT. These osteoarticular pains are the secondary effect on which a physical therapeutic care can have a real benefit.\n\nIt thus appears innovative to complete this care with a therapeutic education program (TEP) in postural yoga which will enable patients to practice yoga postures at home by themselves. Yoga allows a large adaptation to pains expressed by each patient. It will favor the development of the feeling of control that they have in particular on their pain. participants will so improve the self-efficacy, the quality of life, and will reduce their fatigue and their pain. The patients involved have already lived major body transformations because of the disease and treatments. Yoga will help them put their lives together again, both physically and psychologically, and reclaim their body.\n\nStudies have shown the short-term effects of yoga practice on anxiety, stress, pain and quality of life. Few rare studies have suggested that patients could add yoga practice at home to the supervised sessions, but these studies lacked therapeutic patient education. To date, to our knowledge, no data on the effect of the realization of yoga postures at home on increase of the patients' self-competency feeling are available in France. Also, the long-term effects of such programs need to be assessed.\n\nThe Montpellier Cancer Institute (ICM) has set-up 8 years ago yoga sessions for women with breast cancer, together with an association located in Montpellier.\n\nWith this study, the investigators will assess the feasibility of an educational yoga program given by a trained physical therapist in patients with beast cancer treated with hormonotherapy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Non metastatic breast cancer\n* Ongoing hormonotherapy, with no treatment modification in the 30 days before inclusion\n* Osteoarticular pain ≥ 4 (resting or moving) on the VAS (Visual Analogue Scale)\n* Previous treatment (surgery, chemotherapy or radiotherapy) ended at least 2 months before inclusion\n* Informed patient and signed informed consent received\n* Affiliation to a social security category\n\nExclusion Criteria:\n\n* Chronic rheumatologic pain with specific care needed\n* Yoga practice in the 3 months before inclusion\n* Contra-indication or clinical state not allowing physical practice'}, 'identificationModule': {'nctId': 'NCT04001751', 'acronym': 'SKYPE', 'briefTitle': 'Feasibility Study: Yoga Educational Project', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Feasibility Study of the "SKYPE" Educational Project in Patients With Breast Cancer Treated With Hormonotherapy', 'orgStudyIdInfo': {'id': 'PROICM 2018-02 SKY'}, 'secondaryIdInfos': [{'id': '2018-A00208-47', 'type': 'REGISTRY', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic educational postural yoga program', 'description': 'Daily 15-min yoga sessions at home during 12 weeks. One 90-min yoga-therapeutic education session/week (during 6 weeks).', 'interventionNames': ['Behavioral: educational yoga program']}], 'interventions': [{'name': 'educational yoga program', 'type': 'BEHAVIORAL', 'description': 'Daily 15-min yoga sessions at home with the "Le guide du yoga" and the audio-guide, during 12 weeks.\n\nOne 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yoga.', 'armGroupLabels': ['Therapeutic educational postural yoga program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Institut du Cancer de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Kerstin FARAVEL', 'role': 'STUDY_CHAIR', 'affiliation': "Institut du Cancer de Montpellier - Val d'Aurelle"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}