Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center

Completed

• Conditions: Depression; Anxiety Disorders
• Interventions: Other: Transport on foot

• Registration Number: NCT03576482
• Lead Sponsor: Barretos Cancer Hospital

Brief Summary

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.

Detailed Description

A randomized clinical trial, prospective collection to be performed at the Barretos Cancer Hospital, will be include 176 patients, 88 patients being allocated to transport to operating room by stretcher on wheels (group 1) and 88 patients being allocated to transport to operating room by ambulation (group 2). Patients with indication elective surgery that meet the inclusion criteria will be included, and randomized for one of the groups, and may be referred by stretcher on wheels to the surgical center (group 1) or referred to the surgical center by ambulation (group 2). The Hospital Anxiety and Depression Scale (HAD) and the survey developed for the present study Sati-Cir, Evaluation Questionnaire of Satisfaction with Healthcare in Surgery, will be the instruments used in data collection. Participants will respond both after the course to the surgical center.

Study Timeline

• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-07-03
• Study Start: 2019-01-07
• Status Verified: 2021-08
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transport on foot	Transport on foot	Patients go to operating room walking with their families and with their normal clothes

Primary Outcome Measures

Name	Time	Method
Anxiety and depression levels	up to 4 weeks	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

Trial Locations

Locations (1)

Hospital do Câncer de Barretos; 🇧🇷 Barretos, SP, Brazil