Clinical trial NCT04466592: Health and Employment After Gastro Intestinal Surgery - HEAGIS1
Official title: SAlute e LaVoro in Chirurgia Oncologica (SALVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Neoplasms
Stomach Neoplasm
Colonic Neoplasms
Keywords: quality of life
work
social activities
surgery
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Humanitas Hospital, Italy
name: Istituto Oncologico Veneto IRCCS
First posted: 2020-07-10
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will receive the supportive intervention based on the results of the HEADS-DQ during the post operative period.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: participants' health competences
timeFrame: 9 months after the surgery
measure: anxiety and depression
timeFrame: 9 months after the surgery
measure: general quality of life
timeFrame: 9 months after the surgery
Secondary outcomes:
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
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Mirasole S.p.a.
state: Milan
city: Castelfranco Veneto
country: Italy
facility: Istituto Oncologico Veneto - IOV IRCSS
state: Treviso
Study officials:
affiliation: University of Padova
name: Gian Piero Turchi
role: PRINCIPAL_INVESTIGATOR
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