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Esophageal NeoplasmsHEAGIS2NCT04466631

Health and Employment After Gastro Intestinal Surgery - HEAGIS2

An observational study of Esophageal Neoplasms and Gastric Neoplasm, run by University of Padova at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
50 participants
Where
2 sitesItaly
Study dates
15 Jun 2020to Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergone surgery for esophagus or gastrointestinal cancer.

Who may be able to join

  • >18 years old;
  • Comprehension of Italian language;
  • Esophageal or gastrointestinal cancer diagnosis;
  • Curative surgery;
  • No metastasis or neoplasm recurrence.

Who cannot join

  • <18 years old;
  • No comprehension of Italian language;
  • Not esophageal or gastrointestinal cancer diagnosis;
  • Palliative surgery;
  • Metastasis or neoplasm recurrence.

Trial locations and contacts

2 sites in 1 country.

Gian Piero Turchi contact

+39 0498276633

gianpiero.turchi@unipd.it

Alessandro Fabbian contact

+393481492867

alessandro.fabbian@unipd.it

Italy2 sites, 2 recruiting

  • Istituto Oncologico Veneto - IOV IRCSS

    Castelfranco Veneto, Treviso, 31033

    Recruiting

  • Humanitas Mirasole S.p.a.

    Rozzano, Milan, 20089

    Recruiting

Other trials in Italy

About this study

Official title: SAlute e LaVoro in Chirurgia Oncologica (SALVO)

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.

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

Keywords
quality of life, employment, social activities, surgery
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04466631
Study groupRoleWhat they receive
Observative longitudinalThe participants won't receive any support during the post surgery period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 9 months after the surgery

Secondary outcomes (3)

  1. Number of participants maintaining their job

    Measured: 9 months after the surgery

  2. Number of participants with jejunostomy maintaining their job

    Measured: 9 months after the surgery

  3. Number of participants maintaining their social activities

    Measured: 9 months after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2020
  2. Study start15 Jun 2020
  3. Primary completionApr 2021 (estimated)
  4. Study completionApr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04466631
Sponsor's protocol ID
232050b
Acronym
HEAGIS2
Status last verified
Jun 2020
First submitted
7 Jul 2020
Last updated
10 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29733033

  • 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.

    PubMed 21429606

  • 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.

    PubMed 20014202

  • 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.

    PubMed 18851893

  • 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.

    PubMed 20117019

  • 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.

    PubMed 26482347

  • 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.

    PubMed 26121089

  • 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.

    PubMed 26320705

  • 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.

    PubMed 30886599

  • 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.

    PubMed 30528178

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Neoplasms and Gastric Neoplasm, run by University of Padova at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gian Piero Turchi (+39 0498276633, gianpiero.turchi@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Utilization of specific competences by participants (time frame: 9 months after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04466631, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.

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