Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT06477302
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2024-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 281}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contruction of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC)', 'timeFrame': 'the STA-RR-LC will be applied for one time and as soon as the patient has completed one month attending the Respiratory Rehabilitation Service.', 'description': 'The validity of the construction is carried out with an exploratory factor analysis using the Maximum Likelihood extraction method and the oblique rotation (direct Oblimin). Confiability is determitated using the Alpha of Cronbach coefficient.'}], 'secondaryOutcomes': [{'measure': 'Verify the concurrent validity of the instrument', 'timeFrame': 'the STA-RR-LC will be applied one time, as soon as the patient has completed one month attending the Respiratory Rehabilitation Service', 'description': 'It will be verified using the current scores of the European Organisation for Research and Treatment of Cancer, specifically the Module of Lung Cancer (EORTC-QLQ-LC29).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary rehabilitation', 'therapeutic adherence', 'Lung Cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}, {'pmid': '32096582', 'type': 'BACKGROUND', 'citation': 'McFarland DC, Jutagir DR, Miller A, Nelson C. Physical problem list accompanying the distress thermometer: Its associations with psychological symptoms and survival in patients with metastatic lung cancer. Psychooncology. 2020 May;29(5):910-919. doi: 10.1002/pon.5367. Epub 2020 Mar 11.'}, {'pmid': '32145337', 'type': 'BACKGROUND', 'citation': 'Eggen AC, Reyners AKL, Shen G, Bosma I, Jalving M, Leighl NB, Liu G, Richard NM, Mah K, Shultz DB, Edelstein K, Rodin G. Death Anxiety in Patients With Metastatic Non-Small Cell Lung Cancer With and Without Brain Metastases. J Pain Symptom Manage. 2020 Aug;60(2):422-429.e1. doi: 10.1016/j.jpainsymman.2020.02.023. Epub 2020 Mar 5.'}, {'pmid': '31016811', 'type': 'BACKGROUND', 'citation': 'Tan H, Chen S, Ercolano E, Lazenby M, Davies M, Chen J, McCorkle R. The prevalence and related factors associated with psychosocial distress among 420 hospitalised lung cancer patients in China: A case study. Eur J Cancer Care (Engl). 2019 Jul;28(4):e13046. doi: 10.1111/ecc.13046. Epub 2019 Apr 24.'}, {'pmid': '31264308', 'type': 'BACKGROUND', 'citation': 'Papadopoulos D, Kiagia M, Charpidou A, Gkiozos I, Syrigos K. Psychological correlates of sleep quality in lung cancer patients under chemotherapy: A single-center cross-sectional study. Psychooncology. 2019 Sep;28(9):1879-1886. doi: 10.1002/pon.5167. Epub 2019 Jul 18.'}, {'pmid': '29121876', 'type': 'BACKGROUND', 'citation': 'Ernst J, Mehnert A, Dietz A, Hornemann B, Esser P. Perceived stigmatization and its impact on quality of life - results from a large register-based study including breast, colon, prostate and lung cancer patients. BMC Cancer. 2017 Nov 9;17(1):741. doi: 10.1186/s12885-017-3742-2.'}, {'pmid': '28063862', 'type': 'BACKGROUND', 'citation': 'Vodermaier A, Lucas S, Linden W, Olson R. Anxiety After Diagnosis Predicts Lung Cancer-Specific and Overall Survival in Patients With Stage III Non-Small Cell Lung Cancer: A Population-Based Cohort Study. J Pain Symptom Manage. 2017 Jun;53(6):1057-1065. doi: 10.1016/j.jpainsymman.2016.12.338. Epub 2017 Jan 4.'}, {'pmid': '23263699', 'type': 'BACKGROUND', 'citation': 'Arrieta O, Angulo LP, Nunez-Valencia C, Dorantes-Gallareta Y, Macedo EO, Martinez-Lopez D, Alvarado S, Corona-Cruz JF, Onate-Ocana LF. Association of depression and anxiety on quality of life, treatment adherence, and prognosis in patients with advanced non-small cell lung cancer. Ann Surg Oncol. 2013 Jun;20(6):1941-8. doi: 10.1245/s10434-012-2793-5. Epub 2012 Dec 22.'}, {'pmid': '8433390', 'type': 'BACKGROUND', 'citation': 'Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.'}, {'pmid': '7951226', 'type': 'BACKGROUND', 'citation': 'Saad FA, Busque C, Vitiello L, Danieli GA. DXS997 localized to intron 48 of dystrophin. Hum Mol Genet. 1994 Jun;3(6):1034. doi: 10.1093/hmg/3.6.1033. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this non experimental, transversal instrument study is to Construct and determine the reliability and validity of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer in Mexican patients with a lung cancer diagnosis.\n\nThe main question it aims to answer is: What is the reliability and validity of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer of the patients with this diagnosis that are currently undergoing an assessment or follow up program of Respiratory Rehabilitation?\n\nThe Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC) will be psychometrically valid and reliable for the evaluation of therapeutic adherence on patients with lung cancer that are undergoing an assessment or follow up of Respiratory Rehabilitation.Participants will be asked to fill out an Identification card and fill out the fifty-six items presented on the STA-RR-LC.', 'detailedDescription': 'For the recruitment patients with lung cancer diagnosis that arrive at the Respiratory Rehabilitation service will be asked if they are willing to participate and fill out the STA.\n\nIt will be explained to them as clearly as possible the objective, procedure, risks and benefits of the study and a copy of the Informed Consent will be provided. Lung cancer patients attending the Pulmonary Rehabilitation service will be approached and a verbal explanation of the study will be given.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient registered in the national cancer center with respiratory rehabilitation follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with lung cancer (SCLC and NSCLC).\n* Over 18 years of age.\n* Voluntary participation by understanding and accepting the informed consent letter.\n* Patients undergoing Respiratory Rehabilitation treatment with one month assessment and follow-up.\n* Patients in active medical treatment.\n* Any clinical stage.\n* Karnofsky Index ≥ 70.\n\nExclusion Criteria:\n\n* Severe hearing or visual problems that prevent them from understanding the instructions and answering the instruments (this will be identified as reported in the clinical record file).\n* Severe psychiatric conditions (schizophrenia or psychotic disorders) and/or addiction to any psychoactive substance (this will be identified as reported in the INCanet file).\n* Attentional or memory problems that prevent them from understanding the instructions and answering the instruments (this will be identified as reported in the INCanet file).'}, 'identificationModule': {'nctId': 'NCT06477302', 'acronym': 'STA-RR-LC', 'briefTitle': 'Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Cancerologia de Mexico'}, 'officialTitle': 'Construction and Psychometric Properties of the Therapeutic Adherence Scale for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC).', 'orgStudyIdInfo': {'id': '(023/039/ICI)(CEI/045/23)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adherence group', 'description': 'Patients with a confirmed diagnosis of lung cancer who are undergoing respiratory rehabilitation treatment with at least one month of monitoring and follow-up.', 'interventionNames': ['Behavioral: Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer (STA-RR-LC)']}], 'interventions': [{'name': 'Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer (STA-RR-LC)', 'type': 'BEHAVIORAL', 'description': 'Patients will be given a measurement instrument to determine the level of therapeutic adherence.', 'armGroupLabels': ['Adherence group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Oscar G Arrieta, MD', 'role': 'CONTACT', 'email': 'ogar@unam.mx', 'phone': '+52 55 5628 0400', 'phoneExt': '44001'}, {'name': 'Josue R Alcantar-Correa, MD', 'role': 'CONTACT', 'email': 'ricard.alcantar.incan@gmail.com', 'phone': '+52 55 5628 0400', 'phoneExt': '71120'}], 'facility': 'Instituto Nacional de Cancerologia', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Oscar G Arrieta, MD', 'role': 'CONTACT', 'email': 'ogar@unam.mx', 'phone': '+52 55 5628 0400', 'phoneExt': '44001'}, {'name': 'Josue R Alcantar-Correa, MD', 'role': 'CONTACT', 'email': 'richard.alcantar.incan@gmail.com', 'phone': '+52 55 5628 0400', 'phoneExt': '71120'}], 'overallOfficials': [{'name': 'Oscar G Arrieta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Cancerologia (INCan) Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cancerologia de Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Oscar Gerardo Arrieta Rodríguez', 'investigatorAffiliation': 'Instituto Nacional de Cancerologia de Mexico'}}}}