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

NCT05887856 | Enrolling By Invitation DMC

• 1 other identifier: IRB-22-40
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Satisfaction; Preoperative Anxiety; Anxiety

Outcome Measures

Primary Outcomes (1)

• Patient Pre-Operative Anxiety

  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 Outcomes (1)

• Patient Satisfaction.

  6 Months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Non-Intervention Group

NO INTERVENTION

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.

Interventions

comprehensive educational program for reduction of Pre-Operative Anxiety OTHER

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.

Also known as: Breast Surgery Education Package 1 (BSEP 1)

Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years of age.
• Known cases of Breast Cancer.
• Undergoing Breast Surgery as a part of treatment.
• Availability of Personal smart phone at home.
• Written informed Consent given for participation in trial.
• Females.

You may not qualify if:

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

Sponsors & Collaborators

• Shaukat Khanum Memorial Cancer Hospital & Research Centre: lead

Study Sites (1)

Shaukat Khanum memorial cancer hospital and research centre

Lahore, 536500, Pakistan

Location

MeSH Terms

Conditions

Patient Satisfaction; Anxiety Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders

Study Officials

• Dr. Barka Sajjad, M.B.B.S, FCPS, MRCS

  Shaukat Khanum memorial cancer hospital and research centre lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It would be a "single blinded study" the assessor will be blinded to the type of group to which patient belongs. Blinding will be ensured by sharing the data only with relevant study team members, The assessor will read out instruction before beginning of the interview requesting the enrolled patients not to mention the tools used for pre-operative education and to answer only the questions being asked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Muhammad Awais Kanwal

Model Details: Pre-operative randomization after enrollment will be carried out and patients will be allocated either to the "intervention group" or to the "non-intervention group "by 'computerized block randomization'. Research Randomizer software, a free to use software will be used for this. Patients will be randomized either into the intervention group or into non-intervention group.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)