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

NCT03576482 | Completed DMC

• 1 other identifier: 1527/2018
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depression

Keywords

Anxiety disorders; Depression; Transport to operating room

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Transport on foot

Patients go to operating room walking with their families and with their normal clothes

Other: Transport on foot

Transport by stretcher on wheels

Patients go to operating room by stretcher on wheels and with hospital clothes. Normal routine of our hospital.

Interventions

Transport on foot OTHER

Patients go to operating room walking with their families and with their normal clothes

Transport on foot

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Hospital do Câncer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Related Publications (1)

• Oliveira GDS, Sabaini PMDS, Pedrao PG, da Silva VB, Lima MA, Mantovani TEDS, Andrade CEMDC, Dos Reis R. Emotional impact according to the way cancer patients are conducted to the surgical center: A randomized clinical trial comparing ambulation to the stretcher. PLoS One. 2025 Apr 22;20(4):e0320856. doi: 10.1371/journal.pone.0320856. eCollection 2025.

  PMID: 40261947 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Gabriela da S Oliveira, Nurse

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 3, 2018
• Study Start: January 7, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)