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Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors

Primary Purpose

Anxiety Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pre-operative Counseling and Education
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Gynecological cancer, Anxiety, Pre-operative counseling

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients submitted to accessory treatment for tumors of the cervix, vulva, ovary or endometrium.
  • Primary therapy, which may be radiotherapy or chemotherapy.
  • Patients between the ages of 20 and 80 years.
  • Patients submitted to a laparotomic or minimally invasive method (robotic and laparoscopic).
  • Patients should be treated at the Oncology Gynecology Service of the Barretos Cancer Hospital.

Exclusion Criteria:

  • Patients treated at another oncology service previously.
  • Patients who have already been treated for some other cancer in the past.
  • Patients without a complete primary level and / or who can not read or write.
  • Patients and / or family members who refuse to participate in the study.
  • Patients who will be admitted to the ICU.

Sites / Locations

  • Ricardo Reis

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control- group

Experimental Group

Arm Description

It is composed of patients scheduled for surgical treatment by tumors of the uterine cervix, vulva, ovary or endometrium, who will receive preoperative and postoperative guidelines according to the usual routine for the perioperative period of the present institution. Patients and their followers of the control group will participate in a preoperative consultation with the surgeon to discuss the indication of the procedure and its risks, benefits and alternatives to the procedure being indicated, if any. Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)

Composed of patients scheduled for surgical treatment by tumors of the uterine cervix, vulva, ovary or endometrium who will receive preoperative counseling and education through a pre-defined protocol after preoperative consultation with the surgeon. The counseling session will take place with at least one companion. The purpose of this session is to supplement, re-emphasize and strengthen the perioperative guidelines. An illustration (explanatory folder) will be used to demonstrate the location of the surgery, how the scar will be and on which sites of the abdomen and organs the surgery will cover. All this counseling and education will be applied at the same time to the patient and her companion. At the end of the intervention, a space will be left open for both the patient and the companion to ask questions and questions. Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)

Outcomes

Primary Outcome Measures

Anxiety levels
The investigators will measure anxiety levels using the Hospital Anxiety and Depression Scale.The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2018
Last Updated
January 14, 2019
Sponsor
Barretos Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03574155
Brief Title
Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors
Official Title
Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
August 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barretos Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The surgical procedure can be considered a transition in the patient's life. The transition can generate instability and produce negative effects, which may be temporary or permanent. Failure to prepare people to deal with the unexpected, such as diagnosing a disease, such as cancer, and surgical necessity can be a frightening and frustrating experience, developing painful and distressing feelings, involving their family members as well.
Detailed Description
A preoperative orientation process with potential benefits to the patient has been adopted for some surgical procedures. However, recently some surgical specialties such as orthopedics have been implemented in their routine a potentially modifiable conduct of the emotional trauma of a surgery, is the use of the preoperative advice and orientation, in order to attain an ability to increase the client's satisfaction, to facilitate the recovery, decrease the rate of complications without increasing reintegration, decrease hospitalization time and health costs without additional patient risk. There is a belief among surgeons that preoperative counseling and counseling is vitally important for a post-operative outcome. Despite this, there is a paucity of well-conducted studies that examine the importance of the need for preoperative counseling with detailed information to analyze the yearnings and needs as well as the emotional impact. In addition, there are few studies evaluating the emotional impact and impact in the postoperative period in general of detailed preoperative counseling in patients with gynecological tumors submitted to laparotomy and minimally invasive surgery. For these reasons, this study aims to evaluate whether the application of detailed and clear preoperative counseling and education about the surgical procedure to be performed, as well as all the perioperative guidelines that involve the procedure versus the usual preoperative orientation and preoperative, can have an impact on the level of anxiety of the patient and the companion, as well as assess the degree of satisfaction of the companion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Gynecological cancer, Anxiety, Pre-operative counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Group control Pre-operative Orientation Routine Application of the questionnaire (ESAS) and (HADS) Experimental Group Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)
Masking
Investigator
Allocation
Randomized
Enrollment
274 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control- group
Arm Type
No Intervention
Arm Description
It is composed of patients scheduled for surgical treatment by tumors of the uterine cervix, vulva, ovary or endometrium, who will receive preoperative and postoperative guidelines according to the usual routine for the perioperative period of the present institution. Patients and their followers of the control group will participate in a preoperative consultation with the surgeon to discuss the indication of the procedure and its risks, benefits and alternatives to the procedure being indicated, if any. Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Composed of patients scheduled for surgical treatment by tumors of the uterine cervix, vulva, ovary or endometrium who will receive preoperative counseling and education through a pre-defined protocol after preoperative consultation with the surgeon. The counseling session will take place with at least one companion. The purpose of this session is to supplement, re-emphasize and strengthen the perioperative guidelines. An illustration (explanatory folder) will be used to demonstrate the location of the surgery, how the scar will be and on which sites of the abdomen and organs the surgery will cover. All this counseling and education will be applied at the same time to the patient and her companion. At the end of the intervention, a space will be left open for both the patient and the companion to ask questions and questions. Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)
Intervention Type
Behavioral
Intervention Name(s)
Pre-operative Counseling and Education
Other Intervention Name(s)
Application of the questionnaire (ESAS) and (HADS)
Intervention Description
Group control Pre-operative Orientation Routine Application of the questionnaire (ESAS) and (HADS) Post-operative Immediate (1 OP) Application of the Questionnaire to assess HADS and ESAS Anxiety (Patient) Experimental Group Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS) Late postoperative (2 - 4 weeks) Questioning the patient and companion evaluating the degree of satisfaction regarding the preoperative guidelines.
Primary Outcome Measure Information:
Title
Anxiety levels
Description
The investigators will measure anxiety levels using the Hospital Anxiety and Depression Scale.The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal.
Time Frame
up to 2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients submitted to accessory treatment for tumors of the cervix, vulva, ovary or endometrium. Primary therapy, which may be radiotherapy or chemotherapy. Patients between the ages of 20 and 80 years. Patients submitted to a laparotomic or minimally invasive method (robotic and laparoscopic). Patients should be treated at the Oncology Gynecology Service of the Barretos Cancer Hospital. Exclusion Criteria: Patients treated at another oncology service previously. Patients who have already been treated for some other cancer in the past. Patients without a complete primary level and / or who can not read or write. Patients and / or family members who refuse to participate in the study. Patients who will be admitted to the ICU.
Facility Information:
Facility Name
Ricardo Reis
City
Barretos
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors

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