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Health and Employment After Gastro Intestinal Surgery - HEAGIS1 (HEAGIS1)

Primary Purpose

Esophageal Neoplasms, Stomach Neoplasm, Colonic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Promotion of competences of participant involved in the management of the post operative period
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Esophageal Neoplasms focused on measuring quality of life, work, social activities, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Humanitas Mirasole S.p.a.
  • Istituto Oncologico Veneto - IOV IRCSS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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"
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
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)

Secondary Outcome Measures

Number of participants maintaining their job
Number of participants with jejunostomy maintaining their job
Number of participants maintaining their social activities

Full Information

First Posted
July 7, 2020
Last Updated
January 13, 2022
Sponsor
University of Padova
Collaborators
Humanitas Hospital, Italy, Istituto Oncologico Veneto IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT04466592
Brief Title
Health and Employment After Gastro Intestinal Surgery - HEAGIS1
Acronym
HEAGIS1
Official Title
SAlute e LaVoro in Chirurgia Oncologica (SALVO)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova
Collaborators
Humanitas Hospital, Italy, Istituto Oncologico Veneto IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Stomach Neoplasm, Colonic Neoplasms
Keywords
quality of life, work, social activities, surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will receive the supportive intervention based on the results of the HEADS-DQ during the post operative period.
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive intervention
Arm Type
Experimental
Arm Description
A research psychologist will support participants, promoting their competences in the recover of work and social activities, such as the compliance.
Intervention Type
Behavioral
Intervention Name(s)
Promotion of competences of participant involved in the management of the post operative period
Intervention 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).
Primary Outcome Measure Information:
Title
participants' health competences
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"
Time Frame
9 months after the surgery
Title
anxiety and depression
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
Time Frame
9 months after the surgery
Title
general quality of life
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)
Time Frame
9 months after the surgery
Secondary Outcome Measure Information:
Title
Number of participants maintaining their job
Time Frame
9 months after the surgery
Title
Number of participants with jejunostomy maintaining their job
Time Frame
9 months after the surgery
Title
Number of participants maintaining their social activities
Time Frame
9 months after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years old; Comprehension of Italian language; Esophageal or gastro intestinal cancer diagnosis; Curative surgery for neoplasm; No metastasis; Exclusion Criteria: <18 years old Non comprehension of Italian language; No esophageal or gastro intestinal cancer diagnosis; Palliative ; Cancer recurrence or metastasis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gian Piero Turchi
Organizational Affiliation
University of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humanitas Mirasole S.p.a.
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Facility Name
Istituto Oncologico Veneto - IOV IRCSS
City
Castelfranco Veneto
State/Province
Treviso
ZIP/Postal Code
31033
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29733033
Citation
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Results Reference
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PubMed Identifier
21429606
Citation
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Results Reference
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PubMed Identifier
20014202
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.
Results Reference
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PubMed Identifier
18851893
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.
Results Reference
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PubMed Identifier
20117019
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.
Results Reference
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PubMed Identifier
26482347
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.
Results Reference
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PubMed Identifier
26121089
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.
Results Reference
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PubMed Identifier
26320705
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. Erratum In: Ann Epidemiol. 2016 Jul;26(7):520.
Results Reference
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PubMed Identifier
30886599
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.
Results Reference
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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.
Results Reference
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