Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT03781193
Status:
UNKNOWN
Last Update Posted:
2018-12-20
First Post:
2018-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Predictors in Colorectal Cancer Surgery Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C018209', 'term': "4-amino-4'-hydroxylaminodiphenylsulfone"}, {'id': 'C000728125', 'term': 'Perceived Stress Scale'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-07-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-19', 'studyFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between psychological predictors questionnaires outcome and length of hospital stay', 'timeFrame': 'Post-operative day 7', 'description': 'Length of stay calculated in days from the day of surgery until the day of discharge'}, {'measure': 'Correlation between psychological predictors questionnaires outcome and quality of life', 'timeFrame': 'Post-operative day 90', 'description': 'Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)'}, {'measure': 'Correlation between psychological predictors questionnaires outcome and quality of life', 'timeFrame': 'Post-operative month 6', 'description': 'Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)'}, {'measure': 'Correlation between psychological predictors questionnaires outcome and quality of life', 'timeFrame': 'Post-operative month 12', 'description': 'Quality of Life will be assessed by using the European Organization for Research and Treatment of Cancer Quality of Life core Questionnaire (EORTC-QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of life Questionnaire ColoRectal specific module (EORTC-QLQ-CR29)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfulness', 'Psychological predictors', 'Colorectal surgery', 'ERAS'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal cancer surgery.', 'detailedDescription': 'Preliminary evidence suggests that there are multiple variables that may influence the functional recovery following colorectal cancer surgery, some of which deal with the psychological domain. Distress and depression can negatively affect the perceptions of functional ability, while resilience and effective coping styles promote a better psychological adaptation to challenging situations. Furthermore, psychosocial prehabilitation and interventions have been proposed as a feasible and cost-effective way to positively influence the recovery after surgery in association with the Enhanced Recovery After Surgery (ERAS) protocol.\n\nIn particular, mindfulness is proved to be associated with higher quality of life in different medical conditions, including oncological patients and has been also associated with improved clinical outcomes.\n\nThe aim of the study is to investigate the association of mindfulness and other psychological predictors with functional and quality of life outcomes in patients undergoing colorectal surgery for oncological condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Colorectal cancer patients scheduled for elective curative colorectal surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years old (both males and females).\n* Patients diagnosed with colorectal cancer.\n* Patients scheduled for elective open or laparoscopic surgery for curative intent.\n\nExclusion Criteria:\n\n* Patients unable to give the written informed consent.\n* Patients \\< 18 years old.\n* Patients undergoing surgery in emergency setting.\n* Patients with pre-operative evidence of metastatic cancer or colorectal cancer recurrence.\n* Pregnant or breastfeeding patients.\n* Any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia).'}, 'identificationModule': {'nctId': 'NCT03781193', 'acronym': 'MIND', 'briefTitle': 'Psychological Predictors in Colorectal Cancer Surgery Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Psychological Predictors of Post-surgical Recovery in Colorectal Cancer Patients: a Pilot Cohort Study', 'orgStudyIdInfo': {'id': '1945'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaires administration', 'type': 'OTHER', 'description': 'Psychological and quality of life questionnaires'}, {'name': 'Five Facet Mindfulness Questionnaire (FFMQ)', 'type': 'OTHER', 'description': 'FFMQ is a 39-item measure consisting of five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience).'}, {'name': 'Langer Mindfulness Scale (LMS)', 'type': 'OTHER', 'description': 'The LMS Tis a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.'}, {'name': 'Cognitive Flexibility Scale (CFS)', 'type': 'OTHER', 'description': 'The CFS is 12-item self-report test assessing awareness.'}, {'name': 'Life Orientation Test (LOT)', 'type': 'OTHER', 'description': 'The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.'}, {'name': 'Mini Locus of Control test (MLS)', 'type': 'OTHER', 'description': 'The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.'}, {'name': 'Hospital Anxiety and Depression Scale (HADS)', 'type': 'OTHER', 'description': 'The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology'}, {'name': 'Perceived Stress Scale (PSS)', 'type': 'OTHER', 'description': 'The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.'}, {'name': 'Toronto Alexithymia Scale (TAS)', 'type': 'OTHER', 'description': 'The TSA is a 20-item scale that evaluates the three components of alexithymia: difficulty to identify feelings and distinguish between feelings and bodily sensations of emotional arousal difficulty, describing feelings to others, and a cognitive style that is literal, utilitarian, and externally oriented.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Maroli, PhD', 'role': 'CONTACT', 'email': 'annalisa.maroli@humanitas.it', 'phone': '0282247776'}], 'facility': 'IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Annalisa Maroli, PhD', 'role': 'CONTACT', 'email': 'annalisa.maroli@humanitas.it', 'phone': '+.39 02 8224 7776'}, {'name': 'Francesca De Lucia, MD', 'role': 'CONTACT', 'email': 'francesca.delucia@humanitas.it', 'phone': '+39 028224 7776'}], 'overallOfficials': [{'name': 'Antonino Spinelli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Clinico Humanitas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}