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NCT Number: NCT03576482

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital do Câncer de Barretos

Barretos, São Paulo, 14784-400, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transport on foot

Other

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

Primary outcomes

  1. Anxiety and depression levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 3, 2018
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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