Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-31 @ 6:33 AM
Study NCT ID:
NCT06789003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-23
First Post:
2025-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Evaluate the effect of the APA program on fatigue status.', 'timeFrame': 'Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'Cancer Related Fatigue : EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).'}], 'secondaryOutcomes': [{'measure': 'Evaluate the effect of the APA program on quality of life.', 'timeFrame': 'Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'Quality of Life of Cancer Patients : EORTC QLQ-C30 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).'}, {'measure': 'Fitness assessment.', 'timeFrame': 'Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)', 'description': '6-minute walk test.'}, {'measure': 'Fitness assessment.', 'timeFrame': 'Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)', 'description': '30-second chair-stand test.'}, {'measure': 'Fitness assessment.', 'timeFrame': 'Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'Hand grip strength test.'}, {'measure': 'Nutritional status.', 'timeFrame': 'Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'BMI.'}, {'measure': 'Grade III-IV adverse events rate.', 'timeFrame': 'From inclusion to assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0'}, {'measure': 'Comparison of hospitalization length.', 'timeFrame': 'Assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'Hospitalization time (in days) after autologous stem cell transplantation.'}, {'measure': '15. Attraction to sport assessment.', 'timeFrame': 'Assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'IPAQ questionnaire (continuous score expressed as MET-min per week: MET level x minutes of activity/day x days per week, higher score means better outcome)'}, {'measure': 'Adherence rate.', 'timeFrame': 'Assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'Percentage of patients who participated and validated more than 66 percent of the APA sessions recommended by the program.'}, {'measure': 'Attrition rate.', 'timeFrame': 'Assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'Percentage of patients who discontinued the program during the course of the study among patients who received an autologous stem cell transplantation.'}, {'measure': 'Rate of effective APA sessions.', 'timeFrame': 'Assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'Number of validated APA sessions divided by the number of planned sessions.'}, {'measure': 'Reasons for discontinuing the APA program.', 'timeFrame': 'Assessment after transplant (on average about 30 weeks after inclusion)', 'description': 'Self-reported reasons for discontinuation'}, {'measure': "Patient's comments and remarks.", 'timeFrame': '100 days after transplant', 'description': "Patient's follow-up notebook."}, {'measure': 'Patient satisfaction.', 'timeFrame': '100 days after transplant', 'description': 'Satisfaction questionnaire. Likert-type scale (minimum = 0, maximum = 4, higher score means better outcome).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adapted Physical Activity', 'Autologous stem cell transplantation', 'Quality of Life', 'Fatigue'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Adapted physical activity for patients with haematological malignancies generally has positive effects on quality of life, fatigue and physical condition. However, some studies show little or no effect.\n\nThis may be explained by inefficient protocols, but also by low rates of patient acceptability regarding the proposed exercises.\n\nThe multiplicity of APA protocols and the fluctuation of their results mean that validity, methodology and effects on patients need to be verified before they can be considered for implementation in healthcare services. A program must prove its feasibility, but patients must also adhere to it.\n\nAcceptability can be measured by adherence, which represents the number of validated sessions in relation to the number of planned sessions, and by attrition, which corresponds to the number of stops or drop-outs for any reason. The various APA programs offered in the context of intensive auto or allograft treatment are limited, notably by adherence, which can fall by as much as 24%, and attrition, which can be as high as 67%. Optimization of the proposed exercises and follow-up methods is therefore necessary in order to propose an APA program that will be feasible, effective and acceptable to a maximum number of patients.\n\nTo meet these objectives for patients with multiple myeloma eligible for autologous stem cell transplantation, the protocol for this study took into consideration the various recommendations of previous publications and the guidelines from HAS (French National Authority for Health).\n\nThe ultimate goal of this study is to validate, in terms of effectiveness and acceptability, the methodology and in particular the use of new specific tools for optimizing an APA program. It will subsequently be offered to all patients with multiple myeloma eligible for autologous stem cell transplantation, independently of their age or physical condition, while respecting their rhythm and physical condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* CML patient in chronic phase, eligible for oral therapy.\n* Diagnosis of multiple myeloma.\n* Patient eligible for autologous stem cell transplantation.\n* Patient capable to read, understand and complete a questionnaire in french.\n* WHO less than or equal to 2.\n* Patient affiliated with french social security.\n* Patient with a medical prescription for APA.\n\nExclusion Criteria:\n\n* Patient with previous cancer within the previous 3 years (except basal cell and squamous cell skin cancers, carcinomas in situ of any type that have been previously resected, and stable prostate or breast cancers more than 3 years old and undergoing adjuvant hormone therapy).\n* Medical contraindications to APA (heart failure, angina, unbalanced hypertension, bone metastases, severe osteoporosis, etc.)\n* Sensory or motor neuropathy.\n* Patient deprived of liberty, under guardianship or curatorship.\n* Patient considered socially or psychologically unfit to be enrolled in a study.'}, 'identificationModule': {'nctId': 'NCT06789003', 'acronym': 'PREHAB-APA', 'briefTitle': 'Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Henri Duffaut - Avignon'}, 'officialTitle': 'Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment (PREHAB-APA)', 'orgStudyIdInfo': {'id': 'PREHAB-APA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APA group', 'interventionNames': ['Other: Adapted exercises', 'Behavioral: Quality of Life questionnaire', 'Behavioral: Questionnaire of Fatigue', 'Behavioral: Physical activity questionnaire', 'Behavioral: Physical condition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: No intervention', 'Behavioral: Quality of Life questionnaire', 'Behavioral: Questionnaire of Fatigue', 'Behavioral: Physical activity questionnaire', 'Behavioral: Physical condition']}], 'interventions': [{'name': 'Adapted exercises', 'type': 'OTHER', 'description': 'Patients will have 3 sessions a week: 1 strengthening session and 2 endurance sessions.\n\nFor each session, patients will choose the exercises to be performed from the exercise booklet or the videos and records their observations in the patient notebook.\n\nDepending on the treatment plan, patients will have alternating supervised (in hospital) and unsupervised (at home) APA sessions, in order to follow the rhythm of their visits to the department.\n\nEach session will last 45 minutes with a medium intensity according to the Borg scale.', 'armGroupLabels': ['APA group']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'Patients will not be practising adapted exercises as part of the study. They will be treated with chemotherapy according to standard practice.', 'armGroupLabels': ['Control group']}, {'name': 'Quality of Life questionnaire', 'type': 'BEHAVIORAL', 'description': 'QoL questionnaire (EORTC QLQ-C30) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation', 'armGroupLabels': ['APA group', 'Control group']}, {'name': 'Questionnaire of Fatigue', 'type': 'BEHAVIORAL', 'description': 'Questionnaire (EORTC QLQ-FA12) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation', 'armGroupLabels': ['APA group', 'Control group']}, {'name': 'Physical activity questionnaire', 'type': 'BEHAVIORAL', 'description': 'Questionnaire (IPAQ) at baseline and after transplantation', 'armGroupLabels': ['APA group', 'Control group']}, {'name': 'Physical condition', 'type': 'BEHAVIORAL', 'otherNames': ['30s chair-stand test', 'Handgrip strength test', '6 minutes walk test'], 'description': 'Evaluation of physical condition at baseline, mid term (after 2 cycles of chemotherapy), before transplantation and after transplantation', 'armGroupLabels': ['APA group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Avignon', 'country': 'France', 'contacts': [{'name': 'Marilyne Grinand, PhD', 'role': 'CONTACT', 'email': 'grinand.marilyne@ch-avignon.fr', 'phone': '(+33)0432759392'}, {'name': 'Emmanuelle Guilie, APA', 'role': 'CONTACT'}, {'name': 'Safia Chebrek, MD', 'role': 'CONTACT'}], 'facility': "Centre Hospitalier d'Avignon, Hôpital Henri Duffaut", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}], 'centralContacts': [{'name': 'Marilyne Grinand, PhD', 'role': 'CONTACT', 'email': 'grinand.marilyne@ch-avignon.fr', 'phone': '(+33)432759392'}, {'name': 'Emmanuelle Guilie, APA', 'role': 'CONTACT', 'email': 'guilie.emmanuelle@ch-avignon.fr', 'phone': '(+33)432759300'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Henri Duffaut - Avignon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}