Health and Employment After Gastro Intestinal Surgery - HEAGIS2

Esophageal Neoplasms Clinical Trial

— HEAGIS2  

Official title:

SAlute e LaVoro in Chirurgia Oncologica (SALVO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04466631
• Other study ID #: 232050b
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: April 2021

Study information

• Verified date: June 2020
• Source: University of Padova
• Contact: Gian Piero Turchi
• Phone: +39 0498276633
• Email: gianpiero.turchi[@]unipd.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

The principal aim of this study is to create a validated and replicable intervention model for supporting patients who undergone surgery for esophageal and gastro intestinal cancer.

Description:

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.

A 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.

Through this questionnaire participants ability in dealing with after surgery consequences will be evaluated in order to describe their development during the post surgery period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old;

• Comprehension of Italian language;

• Esophageal or gastrointestinal cancer diagnosis;

• Curative surgery;

• No metastasis or neoplasm recurrence.

Exclusion Criteria:

• <18 years old;

• No comprehension of Italian language;

• Not esophageal or gastrointestinal cancer diagnosis;

• Palliative surgery;

• Metastasis or neoplasm recurrence.

Related Conditions & MeSH terms

• Colon Neoplasms
• Colonic Neoplasms
• Esophageal Neoplasms
• Gastric Neoplasm
• Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
Italy	Istituto Oncologico Veneto - IOV IRCSS	Castelfranco Veneto	Treviso
Italy	Humanitas Mirasole S.p.a.	Rozzano	Milan

Sponsors (3)

Lead Sponsor	Collaborator
University of Padova	Humanitas Hospital, Italy, Istituto Oncologico Veneto IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. Erratum in: Ann Epidemiol. 2016 Jul;26(7):520. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utilization of specific competences by participants	Textual data derived from textual analysis: future forethought; context evaluation; consequences of own actions forethought; use of available resources, each relevant to four areas: clinical; familiar; working; daily-activities	9 months after the surgery
Secondary	Number of participants maintaining their job		9 months after the surgery
Secondary	Number of participants with jejunostomy maintaining their job		9 months after the surgery
Secondary	Number of participants maintaining their social activities		9 months after the surgery