Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: a Randomized Controlled Trial (PAUSDE)

November 1, 2024 updated by: Dr. Muhammad Awais Kanwal, Shaukat Khanum Memorial Cancer Hospital & Research Centre
This study aims to find out that if a specially designed educational program can help in reduction of pre-operative anxiety in breast cancer patients undergoing surgery as a part of their treatment.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Anxiety can be defined as an unpleasant subjective experience associated with the perception of real threat; therefore, it is a common symptom in connection with cancer. Breast Cancer patients undergo surgery at some stage of their treatment, Surgery details can be overwhelming and might lead to low retention of information and greater levels of anxiety which is the most prevalent psychological symptoms perceived by cancer patients.

Studies have shown women with a diagnosis of cancer correlate with higher levels of preoperative anxiety. Increased anxiety elicits physiologic stress responses that may impede healing and alter responses to postoperative pain.It can also lead to delayed recovery, prolonged hospital stay and increased need of postoperative pain medications.

Pre-Operative Anxiety may also cause delayed recovery from Anesthesia and can also compromise the effectiveness of anesthesia .Furthermore, it can lead to other post-operative complications such as nausea, vomiting, and delayed wound healing. Various Pharmacological and non-pharmacological methods have been used for reduction of pre-operative anxiety and one such non-pharmacological method is educating the patients about the experience of surgery pre-operatively which we aim to study in our population.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan, 536500
        • Shaukat Khanum Memorial Cancer Hospital and Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 to 70 years of age.
  2. Known cases of Breast Cancer.
  3. Undergoing Breast Surgery as a part of treatment.
  4. Availability of Personal smart phone at home.
  5. Written informed Consent given for participation in trial.
  6. Females.

Exclusion Criteria:

  1. Less than 18 years or more than 70 years of age.
  2. Stage IV patients undergoing palliative breast surgery.
  3. Patient having chronic pain.
  4. Un-availability of smart phone.
  5. Patients with known psychiatric/depression disorders.
  6. Previous history of another treated carcinoma.
  7. Patients with re-current breast carcinoma.
  8. Male Patients are excluded from study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Group
Volunteers in the Intervention group will receive specially designed educational program which will be aimed at reduction of pre-operative anxiety in breast cancer patients undergoing surgery as a part of their treatment.
Other: comprehensive educational program for reduction of Pre-Operative Anxiety

BSEP 1 makes use of modern media and aims to educate patients and their carers through educational videos comprising of various aspect of surgical treatment.

  1. Introduction to surgery by consultant surgeon, Patient to receive video of their own surgeon.
  2. Introduction to Anesthesia.
  3. What are different type of breast surgeries in cancer patients (General Video)
  4. Specific video pertaining to the type of surgery patient is undergoing (Mastectomy, Breast Conserving Surgery, Breast Re Construction surgery)
  5. Explanation of Methicillin-resistant Staphylococcus aureus Decolonization protocol
  6. What to expect on Surgery Day
  7. Virtual tour of Holding bay and Operation Room
  8. Post-Operative care including wound care, drain management and common post-operative complications.
Other Names:
  • Breast Surgery Education Package 1 (BSEP 1)
No Intervention: Non-Intervention Group

Non-Intervention group will get the usual standard information as per existing protocols which includes

  1. Explanation of surgical procedure by primary team.
  2. Information about anesthesia on pre-operative anesthesia assessment.
  3. Phone call from Primary team explaining surgery details one day prior to surgery in case of day case surgery.
  4. Information about surgery on admission from floor resident in case of Pre-Op Admission.

Afore mentioned practices are standard at SKMCH and RC and will remain same for both intervention and non-intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Pre-Operative Anxiety
Time Frame: 6 months

This will be measured by using The Perioperative Anxiety Scale-7 (PAS-7), PAS 7 is a validated tool which includes seven items. This tool was developed by Zhang, C., Liu, X., Hu, T. et al. at Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Permissions were obtained and granted for use of PAS 7 in this project and its translation into Urdu. The process of translation involved forward translation by two independent translators, formation of a reconciled version by third translator, Back translation, independent review and finalization.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction.
Time Frame: 6 Months
This will be measured using Patient satisfaction questionnaire Short Form (PSQ-18). The short-form instrument, the PSQ-18, contains 18 items comprising of General satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience. PSQ-18 is a free to use validated tool developed by RAND Corporation. The translation of the tool is allowed by the RAND Corporation with precise instructions regarding the translation process. These instructions were followed while translating the tool. The process of translation involved forward translation by two independent translators, formation of a reconciled version by third translator, Back translation, independent review and finalization.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Investigators

  • Principal Investigator: Dr. Barka Sajjad, M.B.B.S, FCPS, MRCS, Shaukat Khanum memorial cancer hospital and research centre lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-22-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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