Patient SatisfactionPAUSDENCT05887856

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

A study testing comprehensive educational program for reduction of Pre-Operative Anxiety in people with Patient Satisfaction and Preoperative Anxiety, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Patient Satisfaction, Preoperative Anxiety, Anxiety
What is being tested?: comprehensive educational program for reduction of Pre-Operative Anxiety
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 sitePakistan
Study dates: 1 Nov 2024to Oct 2025
Phase: Interventional
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

18 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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Shaukat Khanum memorial cancer hospital and research centre
Lahore, 536500

Other trials in Pakistan

About this study

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.

Read the 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.

Conditions: Patient Satisfaction, Preoperative Anxiety, Anxiety
Being tested: comprehensive educational program for reduction of Pre-Operative Anxiety
Medical subject headings: Patient Satisfaction, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

comprehensive educational program for reduction of Pre-Operative AnxietyOther
Also called Breast Surgery Education Package 1 (BSEP 1)
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.

Study groups in NCT05887856
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (1)

Patient Satisfaction.
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.
Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 2024Oct 2025

First posted5 Jun 2023
Study start1 Nov 2024
Primary completionMay 2025 (estimated)
Study completionOct 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Patient SatisfactionStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05887856
Sponsor's protocol ID: IRB-22-40
Acronym: PAUSDE
Status last verified: Aug 2024
First submitted: 24 May 2023
Last updated: 4 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05887856
Acronym / sponsor ID: PAUSDE / IRB-22-40
Conditions: Patient Satisfaction, Preoperative Anxiety, Anxiety
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 400 participants (estimated)
Lead sponsor: Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
Study start: 1 Nov 2024 (actual)
Primary completion: May 2025 (estimated)
Study completion: Oct 2025 (estimated)
First posted: 5 Jun 2023 (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.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Intervention Group	Active comparator	Other: comprehensive educational program for reduction of Pre-Operative AnxietyVolunteers 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.
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.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

18 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.

Key exclusion criteria (8 listed)

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.

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
comprehensive educational program for reduction of Pre-Operative AnxietyAlso: Breast Surgery Education Package 1 (BSEP 1)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	Intervention Group

Primary outcome

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.

1 secondary outcome

Patient Satisfaction.
Time frame: 6 Months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
Individual participant dataSharing planned: No

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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.

Dr. Barka Sajjad, M.B.B.S, FCPS, MRCS principal investigator

Shaukat Khanum memorial cancer hospital and research centre lahore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: status not confirmed, as of the sponsor's last update on 4 Nov 2024. 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 Pakistan. 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?

Results are not available in the source record.

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?

Patient Pre-Operative Anxiety (time frame: 6 months). 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 NCT05887856.

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 4 Nov 2024.