Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-04-20 @ 12:47 PM
Study NCT ID:
NCT04466592
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health and Employment After Gastro Intestinal Surgery - HEAGIS1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will receive the supportive intervention based on the results of the HEADS-DQ during the post operative period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "participants' health competences", 'timeFrame': '9 months after the surgery', 'description': 'competences measured by HEAGIS-DQ. competences measured by HEAGIS-DQ (Health and Employment After Gastro intestinal Surgery - Dialogical Questionnaire): the questionnaire gives an evaluation of the four competences (future forethought; context evaluation; consequences of own actions forethought; use of available resources), for each of the four areas(clinical; familiar; working; daily-activities). Each competence can be "low", "medium" or "high". Best level: "high level"'}, {'measure': 'anxiety and depression', 'timeFrame': '9 months after the surgery', 'description': 'HADS - Hospital Anxiety and Depression Scale measures. score range for depression: 0 - 7 Normal / 8 - 10 borderline / 11 - 17 Abnormal score range for Anxiety: 0 - 7 Normal / 8 - 10 borderline / 11 - 17 Abnormal'}, {'measure': 'general quality of life', 'timeFrame': '9 months after the surgery', 'description': 'measured by EORTC QLQ C30 (European Organisation for Research and Treatment of Cancer - Quality of Life of Cancer patients) Role, social, emotional scales: range score for functional scale: 0 (worst) - 100 (best) Financial difficulties: range score for symptoms scale: 0 (best) - 100 (worst) Global health status: range score for global health: 0 (worst) - 100 (best)'}], 'secondaryOutcomes': [{'measure': 'Number of participants maintaining their job', 'timeFrame': '9 months after the surgery'}, {'measure': 'Number of participants with jejunostomy maintaining their job', 'timeFrame': '9 months after the surgery'}, {'measure': 'Number of participants maintaining their social activities', 'timeFrame': '9 months after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of life', 'work', 'social activities', 'surgery'], 'conditions': ['Esophageal Neoplasms', 'Stomach Neoplasm', 'Colonic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '29733033', 'type': 'BACKGROUND', 'citation': 'De Blasi G, Bouteyre E, Rollin L. Giving up work after cancer: An exploratory qualitative study of three clinical cases. Work. 2018;60(1):105-115. doi: 10.3233/WOR-182712.'}, {'pmid': '21429606', 'type': 'BACKGROUND', 'citation': 'Moran JR, Short PF, Hollenbeak CS. Long-term employment effects of surviving cancer. J Health Econ. 2011 May;30(3):505-14. doi: 10.1016/j.jhealeco.2011.02.001. Epub 2011 Mar 1.'}, {'pmid': '20014202', 'type': 'BACKGROUND', 'citation': 'Yarker J, Munir F, Bains M, Kalawsky K, Haslam C. The role of communication and support in return to work following cancer-related absence. Psychooncology. 2010 Oct;19(10):1078-85. doi: 10.1002/pon.1662.'}, {'pmid': '18851893', 'type': 'BACKGROUND', 'citation': 'Parsons JA, Eakin JM, Bell RS, Franche RL, Davis AM. "So, are you back to work yet?" Re-conceptualizing \'work\' and \'return to work\' in the context of primary bone cancer. Soc Sci Med. 2008 Dec;67(11):1826-36. doi: 10.1016/j.socscimed.2008.09.011. Epub 2008 Oct 11.'}, {'pmid': '20117019', 'type': 'BACKGROUND', 'citation': 'Mehnert A. Employment and work-related issues in cancer survivors. Crit Rev Oncol Hematol. 2011 Feb;77(2):109-30. doi: 10.1016/j.critrevonc.2010.01.004. Epub 2010 Feb 8.'}, {'pmid': '26482347', 'type': 'BACKGROUND', 'citation': "Pinto E, Cavallin F, Alfieri R, Saadeh LM, Mantoan S, Cagol M, Castoro C, Scarpa M. Impact of esophagectomy for cancer on patients' occupational status. Eur J Surg Oncol. 2016 Jan;42(1):103-9. doi: 10.1016/j.ejso.2015.09.021. Epub 2015 Oct 9."}, {'pmid': '26121089', 'type': 'BACKGROUND', 'citation': 'Martinez LR, White CD, Shapiro JR, Hebl MR. Selection BIAS: Stereotypes and discrimination related to having a history of cancer. J Appl Psychol. 2016 Jan;101(1):122-8. doi: 10.1037/apl0000036. Epub 2015 Jun 29.'}, {'pmid': '26320705', 'type': 'BACKGROUND', 'citation': 'Clarke TC, Christ SL, Soler-Vila H, Lee DJ, Arheart KL, Prado G, Caban-Martinez A, Fleming LE. Working with cancer: health and employment among cancer survivors. Ann Epidemiol. 2015 Nov;25(11):832-8. doi: 10.1016/j.annepidem.2015.07.011. Epub 2015 Aug 4.'}, {'pmid': '30886599', 'type': 'BACKGROUND', 'citation': 'Turchi GP, Iudici A, Faccio E. From Suicide Due to an Economic-Financial Crisis to the Management of Entrepreneurial Health: Elements of a Biographical Change Management Service and Clinical Implications. Front Psychol. 2019 Mar 4;10:426. doi: 10.3389/fpsyg.2019.00426. eCollection 2019. No abstract available.'}, {'pmid': '30528178', 'type': 'BACKGROUND', 'citation': 'Iudici A, Favaretto G, Turchi GP. Community perspective: How volunteers, professionals, families and the general population construct disability: Social, clinical and health implications. Disabil Health J. 2019 Apr;12(2):171-179. doi: 10.1016/j.dhjo.2018.11.014. Epub 2018 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'By using the M.A.D.I.T. methodology and the Dialogics science, SALVO Project aims to develop operational guidelines to support oncological target patients in the resumption of their daily post-operative activities. The research will implement an instrument for the purpose of measuring the health need of participants who are admitted to the surgical ward. Therefore, targeted interventions will be implemented with participants, and efficacy will be evaluated in order to define treatment guidelines.\n\nThe principal aim of this study is to create a validated and replicable intervention model for supporting patients who undergone surgery for esophagus and gastro intestinal cancer.', 'detailedDescription': 'Several studies highlight how patients diagnosed with a digestive tract cancer, experience difficulties in returning to work after treatment, leading to socio-economic spill-over effects.\n\nA specific 16 questions questionnaire had been developed for this study, the "Health and Employment After Gastro Intestinal Surgery Dialogical Questionnaire" (HEADS-DQ). It investigate peculiar patient competences involved after surgery: future forethought; context evaluation; consequences of own actions forethought; use of available resources, each relevant to four areas: clinical; familiar; working; daily-activities.\n\nThrough this questionnaire patient ability in dealing with after surgery consequences will be evaluated in order to define targeted support, which will be offered by professional psychologists. These interventions efficacy will be evaluated through another administration of the HEADS-DQ.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old;\n* Comprehension of Italian language;\n* Esophageal or gastro intestinal cancer diagnosis;\n* Curative surgery for neoplasm;\n* No metastasis;\n\nExclusion Criteria:\n\n* \\<18 years old\n* Non comprehension of Italian language;\n* No esophageal or gastro intestinal cancer diagnosis;\n* Palliative ;\n* Cancer recurrence or metastasis.'}, 'identificationModule': {'nctId': 'NCT04466592', 'acronym': 'HEAGIS1', 'briefTitle': 'Health and Employment After Gastro Intestinal Surgery - HEAGIS1', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'SAlute e LaVoro in Chirurgia Oncologica (SALVO)', 'orgStudyIdInfo': {'id': '232050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive intervention', 'description': 'A research psychologist will support participants, promoting their competences in the recover of work and social activities, such as the compliance.', 'interventionNames': ['Behavioral: Promotion of competences of participant involved in the management of the post operative period']}], 'interventions': [{'name': 'Promotion of competences of participant involved in the management of the post operative period', 'type': 'BEHAVIORAL', 'description': 'The research psychologist will be in touch with the participants for 9 months after the surgery (weekly, biweekly or monthly) in order to help them recovering social and work activities, and dealing with the consequences of the surgery. Specifically, four competences will be promoted (future forethought; context evaluation; consequences of own actions forethought; use of available resources), each relevant to four areas (clinical; familiar; working; daily-activities).', 'armGroupLabels': ['Supportive intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'country': 'Italy', 'facility': 'Humanitas Mirasole S.p.a.', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '31033', 'city': 'Castelfranco Veneto', 'state': 'Treviso', 'country': 'Italy', 'facility': 'Istituto Oncologico Veneto - IOV IRCSS', 'geoPoint': {'lat': 45.67146, 'lon': 11.92755}}], 'overallOfficials': [{'name': 'Gian Piero Turchi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Padova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'collaborators': [{'name': 'Humanitas Hospital, Italy', 'class': 'OTHER'}, {'name': 'Istituto Oncologico Veneto IRCCS', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}