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Clinical Trials/NCT04466631
NCT04466631UnknownNot Applicable

SAlute e LaVoro in Chirurgia Oncologica (SALVO)

University of Padova2 sites in 1 country50 target enrollmentStarted: June 15, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Utilization of specific competences by participants

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Utilization of specific competences by participants

Time Frame: 9 months after the surgery

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

Secondary Outcomes

  • Number of participants maintaining their social activities(9 months after the surgery)
  • Number of participants maintaining their job(9 months after the surgery)
  • Number of participants with jejunostomy maintaining their job(9 months after the surgery)

Investigators

Sponsor
University of Padova
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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