Esophageal Neoplasms Clinical Trial
— HEAGIS2Official title:
SAlute e LaVoro in Chirurgia Oncologica (SALVO)
NCT number | NCT04466631 |
Other study ID # | 232050b |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 15, 2020 |
Est. completion date | April 2021 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | April 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Oncologico Veneto - IOV IRCSS | Castelfranco Veneto | Treviso |
Italy | Humanitas Mirasole S.p.a. | Rozzano | Milan |
Lead Sponsor | Collaborator |
---|---|
University of Padova | Humanitas Hospital, Italy, Istituto Oncologico Veneto IRCCS |
Italy,
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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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 9 months after the surgery | |
Secondary | Number of participants maintaining their job | 9 months after the surgery | ||
Secondary | Number of participants with jejunostomy maintaining their job | 9 months after the surgery | ||
Secondary | Number of participants maintaining their social activities | 9 months after the surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
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