Clinical trial NCT03576482: Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorders
Depression
Keywords: Anxiety disorders
Depression
Transport to operating room
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be organized including 176 patients sheduled for elective cancer surgery at Barretos Cancer Hospital, 88 patients bei ng allocated for transporting to the operating room by stretcher on wheels, and 88 patients elective allocated for transporting to the operating room by ambulation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety and depression levels
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Hospital do Câncer de Barretos
state: SP
Study officials:
affiliation: Barretos Cancer Hospital
name: Gabriela da S Oliveira, Nurse
role: PRINCIPAL_INVESTIGATOR
References: