Health and Employment After Gastro Intestinal Surgery - HEAGIS1

Study Overview
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Brief Summary
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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
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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.

Official Title
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SAlute e LaVoro in Chirurgia Oncologica (SALVO)

Conditions
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Esophageal Neoplasms, Stomach Neoplasm, Colonic Neoplasms

Intervention / Treatment
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* Behavioral: Promotion of competences of participant involved in the management of the post operative period


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive intervention<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, work, social activities, surgery