Anxiety DisordersNCT03576482
Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center
An observational study of Anxiety Disorders and Depression, run by Barretos Cancer Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety Disorders, Depression
- What is being tested?
- Transport on foot
- How many people
- 176 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jan 2019to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Anxiety Disorders, Depression
- Being tested
- Transport on foot
- Keywords
- Anxiety disorders, Depression, Transport to operating room
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transport on footOther
Patients go to operating room walking with their families and with their normal clothes
| Study group | Role | What they receive |
|---|---|---|
| Transport on foot | Patients go to operating room walking with their families and with their normal clothes Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start7 Jan 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo dos Reis, Barretos Cancer Hospital
- Investigators
- Gabriela da S Oliveira, Nurse, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576482
- Sponsor's protocol ID
- 1527/2018
- Status last verified
- Aug 2021
- First submitted
- 13 Jun 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not intend to share our individual participant data to other researches
Publications
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.
PubMed 40261947
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03576482
- Acronym / sponsor ID
- 1527/2018
- Conditions
- Anxiety Disorders, Depression
- Keywords
- Anxiety disorders, Depression, Transport to operating room
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transport on foot | – | Other: Transport on footPatients go to operating room walking with their families and with their normal clothes |
| Transport by stretcher on wheels | – | –Patients go to operating room by stretcher on wheels and with hospital clothes. Normal routine of our hospital. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transport on footPatients go to operating room walking with their families and with their normal clothes | Other | Transport on foot |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 40261947Oliveira 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.
- Individual participant dataSharing planned: No. We do not intend to share our individual participant data to other researches
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela da S Oliveira, Nurse principal investigator
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Depression, run by Barretos Cancer Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depression levels (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.