Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2021
Source Barretos Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Transport on foot
Patients go to operating room walking with their families and with their normal clothes

Locations

Country Name City State
Brazil Hospital do Câncer de Barretos Barretos SP

Sponsors (1)

Lead Sponsor Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A