Depression Clinical Trial
Official title:
Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center: a Randomized Clinical Trial Comparing Transport by Stretcher on Wheels and Ambulation.
NCT number | NCT03576482 |
Other study ID # | 1527/2018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 7, 2019 |
Est. completion date | August 30, 2021 |
Verified date | August 2021 |
Source | Barretos Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cancer is an extremely aggressive disease, anxiety and depression are consequences some patients may develop from diagnosis continuing during treatment. A measures control of the cancer is surgery for removal tumor. The surgical procedure is often a difficult experience for patients and their relatives, and patients in the preoperative period are often psychological symptoms of anxiety and depression. A previous study with the objective analyzing patient's emotional repercussion according the type of transport to the surgical center reached the following result: patients who go to the surgical center feel more relaxed in the preoperative period. The primary objective is to analyze emotional repercussion of patient diagnosed with cancer classified in Eastern Cooperative Oncology Group (ECOG) Performance Status 0 and 1 according type transport to the surgical center.
Status | Completed |
Enrollment | 176 |
Est. completion date | August 30, 2021 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - diagnosed cancer - Age =18 years, = 70 years - Both sexes - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1 - Patients classified as Zero or Low Risk by the fall risk assessment scale - Indication elective surgery Exclusion Criteria: - Patients who present moments before surgery has an adverse event that could jeopardize the ambulation to the surgical center. - Patients who are physically disabled and require assistance walking. - Patients has indication bed in the Intensive Care Unit (UTI) - Patients has previously diagnosed psychiatric disorders (severe depression, anxiety disorder, panic, among others). - Patients doens't have an accompanying person on the day of surgery. - Patients taking anxiolytic and antidepressant medications. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital do Câncer de Barretos | Barretos | SP |
Lead Sponsor | Collaborator |
---|---|
Barretos Cancer Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety and depression levels | Measure the anxiety and depression levels using Hospital Anxiety and Depression Scale (HAD) and the survey developed for the present study Sati-Cir, Evaluation Questionnaire of Satisfaction with Healthcare in Surgery | up to 4 weeks |
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