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Completed

NCT Number: NCT04466592

Health and Employment After Gastro Intestinal Surgery - HEAGIS1

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.

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Key information

Conditions

Esophageal Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasm Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Humanitas Mirasole S.p.a., Rozzano, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Promotion of competences of participant involved in the management of the post operative period

Behavioral

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 outcomes

  1. participants' health competences

    Time frame: 9 months after the surgery

    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"

  2. anxiety and depression

    Time frame: 9 months after the surgery

    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

  3. general quality of life

    Time frame: 9 months after the surgery

    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 outcomes

  1. Number of participants maintaining their job

    Time frame: 9 months after the surgery

  2. Number of participants with jejunostomy maintaining their job

    Time frame: 9 months after the surgery

  3. Number of participants maintaining their social activities

    Time frame: 9 months after the surgery

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

  • Humanitas Hospital, Italy
  • Istituto Oncologico Veneto IRCCS

Registry information

Official study title

SAlute e LaVoro in Chirurgia Oncologica (SALVO)

Acronym: HEAGIS1

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2020
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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