Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
Study NCT ID:
NCT06534957
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Given the nature of the intervention, the study will be open and participants will know which group they were randomized to. However, the study will be blinded to the statistician in order to reduce the risk of introducing bias when interpreting the data.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress', 'timeFrame': '11 weeks', 'description': 'Measured through the Perceived Stress Scale (PSS). The PSS is a self-report instrument that assesses the level of perceived stress over the past month. It consists of 10 items that are rated using a 5-point Likert scale (0: Never; 1: Almost never; 2: Sometimes; 3: Fairly often; 4: Very often). The total score is obtained by adding the scores of the 10 items, obtaining a total value between 0-40, where higher scores indicate a higher level of perceived stress. A moderate stress level is considered between 20-25 points, and a high stress level is considered when obtaining \\>25 points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfulness-based stress reduction', 'chemotherapy-related stress', 'breast cancer'], 'conditions': ['Breast Cancer', 'Stress']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based stress reduction (MBSR) intervention reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy.\n\nThe main questions it aims to answer are:\n\n* Does an online MBSR intervention reduce stress levels (measured through the Perceived Stress Scale) among participants?\n* Does an online MBSR intervention reduce anxiety, depression, insomnia, fatigue, nausea, diarrhea, constipation, pain, and peripheral neuropathy (measured through the PRO-CTCAE of the National Cancer Institute) among participants?\n\nResearchers will compare the online MBSR intervention to no intervention to see if online MBSR reduces treatment-related stress.\n\nParticipants will:\n\n* Participate in an online MBSR intervention or no intervention for 6 weeks\n* Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female sex\n* Age ≥18 years\n* Diagnosis of non-metastatic breast cancer\n* Plan to start neoadjuvant or adjuvant chemotherapy in \\<4 weeks\n* Internet access at home or in their mobile phone\n* Availability to participate in the online MBSR intervention for 6 weeks\n* Availability to answer the study surveys\n* Provision of signed informed consent\n\nExclusion Criteria:\n\n* Disease recurrence\n* Current meditation or mindfulness practice\n* Inability to read or write'}, 'identificationModule': {'nctId': 'NCT06534957', 'briefTitle': 'Online Mindfulness-based Stress Reduction for Patients Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Medicos e Investigadores en la Lucha contra el Cancer de Mama'}, 'officialTitle': 'Online Mindfulness-based Stress Reduction Intervention for Patients With Breast Cancer Receiving Chemotherapy', 'orgStudyIdInfo': {'id': 'ECA-MIND-QT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The intervention group will be assessed with the study surveys at baseline (T1), will participate in the online MBSR intervention for the next 6 weeks, and will be subsequently reassessed with the study surveys at 7 weeks (T2) and at 11 weeks (T3) of follow-up.', 'interventionNames': ['Other: Online mindfulness-based stress reduction']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control group', 'description': "A wait-list control group will be used with the objective that all participants have the opportunity of receiving the online MBSR intervention and at the same time allow comparison of the effectiveness of the program with a group without intervention. Given that treatment-related stress has an important negative impact on patients' wellbeing, it is appropriate to offer the control group the possibility of receiving the intervention if its effectiveness is demonstrated.\n\nThe control group will be assessed with the study surveys at baseline (T1), will not participate in the online MBSR intervention for the next 6 weeks, and will be subsequently reassessed with the study surveys at the same timepoints as the intervention group at 7 weeks (T2) and at 11 weeks (T3) of follow-up. Upon completion of recruitment and follow-up of all participants, the study will end, and the control group will be able to receive the online MBSR intervention according to their preference."}], 'interventions': [{'name': 'Online mindfulness-based stress reduction', 'type': 'OTHER', 'description': 'The online MBSR intervention sessions will be available in a website created specifically for this purpose, where each pre-recorded session will be uploaded so that each patient can begin the intervention at the same time as their chemotherapy regimen. Each session will last approximately 1 hour, for a total of 6 sessions. The topics that will be covered in these sessions include: mindfulness overview, stress and suffering, emotional regulation, meditation, management of stressful situations, self-compassion and acceptance. Participants will watch 1 session per week following the order that will be indicated on the website; patients will be encouraged to watch the sessions during their chemotherapy infusions. During these sessions, patients will be instructed in mindfulness practice and will perform targeted exercises to promote complete consciousness, including mindful body awareness (body scan), gentle yoga exercises, and meditation.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66278', 'city': 'San Pedro Garza García', 'state': 'Nuevo León', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Fernanda Mesa-Chavez, MD, MSc', 'role': 'CONTACT', 'email': 'fernanda.mesa@tecsalud.mx', 'phone': '+52-81-8888-0442'}], 'facility': 'Hospital Zambrano Hellion', 'geoPoint': {'lat': 25.6604, 'lon': -100.40651}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicos e Investigadores en la Lucha contra el Cancer de Mama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fernanda Mesa-Chavez', 'investigatorAffiliation': 'Medicos e Investigadores en la Lucha contra el Cancer de Mama'}}}}