Health and Employment After Gastro Intestinal Surgery - HEAGIS1

NCT04466592 | Completed

• 1 other identifier: 232050
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief 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 esophagus and gastro intestinal cancer.

Conditions

Esophageal Neoplasms; Stomach Neoplasm; Colonic Neoplasms

Keywords

quality of life; work; social activities; surgery

Outcome Measures

Primary Outcomes (3)

• participants' health competences

  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"

  9 months after the surgery

• anxiety and depression

  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

  9 months after the surgery

• general quality of life

  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)

  9 months after the surgery

Secondary Outcomes (3)

• Number of participants maintaining their job

  9 months after the surgery

• Number of participants with jejunostomy maintaining their job

  9 months after the surgery

• Number of participants maintaining their social activities

  9 months after the surgery

Study Arms (1)

Supportive intervention

EXPERIMENTAL

A research psychologist will support participants, promoting their competences in the recover of work and social activities, such as the compliance.

Behavioral: Promotion of competences of participant involved in the management of the post operative period

Interventions

Promotion of competences of participant involved in the management of the post operative period BEHAVIORAL

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).

Supportive intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old;
• Comprehension of Italian language;
• Esophageal or gastro intestinal cancer diagnosis;
• Curative surgery for neoplasm;
• No metastasis;

You may not qualify if:

• \<18 years old
• Non comprehension of Italian language;
• No esophageal or gastro intestinal cancer diagnosis;
• Palliative ;
• Cancer recurrence or metastasis.

Sponsors & Collaborators

• University of Padova: lead
• Humanitas Hospital, Italy: collaborator
• Istituto Oncologico Veneto IRCCS: collaborator

Study Sites (2)

Humanitas Mirasole S.p.a.

Rozzano, Milan, 20089, Italy

Location

Istituto Oncologico Veneto - IOV IRCSS

Castelfranco Veneto, Treviso, 31033, Italy

Location

Related Publications (10)

• 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: 29733033 BACKGROUND

• 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: 21429606 BACKGROUND

• 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: 20014202 BACKGROUND

• 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: 18851893 BACKGROUND

• 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: 20117019 BACKGROUND

• 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: 26482347 BACKGROUND

• 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: 26121089 BACKGROUND

• 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: 26320705 BACKGROUND

• 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: 30886599 BACKGROUND

• 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.

  PMID: 30528178 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases

Study Officials

• Gian Piero Turchi

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive the supportive intervention based on the results of the HEADS-DQ during the post operative period.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: December 13, 2019
• Primary Completion: February 28, 2021
• Study Completion: April 30, 2021
• Last Updated: January 14, 2022

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)