Comparing Patient Satisfaction in Post-operative Breast Surgery Patients Having Physical Clinic and Tele Clinic Follow up: A Randomized Controlled Trial

NCT05627193 | Completed DMC

• 1 other identifier: IRB-22-34
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

The Purpose of this study is to measure patient satisfaction in standard Post- operative Breast Outpatient clinics versus teleclinics. Post operative breast surgery patients who volunteer for this study will be randomized into either of the two groups Standard outpatient physical clinics or Telephone clinic and their satisfaction will be measured afterwards using a validated standardized questionnaire by a assessor who will be blind to the type of follow up. This will be a single blinded randomized controlled trial.

Conditions

Satisfaction, Patient; Satisfaction

Keywords

patient satisfaction; teleclinic; physical clinic; outpatient clinic; breast surgery; virtual clinics; randomized controlled trial; RCT; PSPVT Trial

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  Patient satisfaction will be measured using Patient satisfaction questionnaire Short Form (PSQ-18). The short-form instrument, the PSQ-18, contains 18 items tapping each of the seven dimensions of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. PSQ-18 is a free to use validated tool developed by RAND Corporation.

  3 weeks

Secondary Outcomes (2)

• Post operative complications

  6 weeks

• Number of Emergency assessment room visits prior to follow up in Physical or Tele Clinic

  2 weeks

Study Arms (2)

Traditional out patient clinic

ACTIVE COMPARATOR

The volunteers of the study randomized into this group will be given traditional outpatient clinic follow up post surgery.

Other: Physical Clinic

Teleclinic

ACTIVE COMPARATOR

The Volunteer of the study randomized into this group will be given teleclinic appointment for follow up post surgery.

Other: Teleclinic

Interventions

Teleclinic OTHER

Instead of visiting surgeon after travelling from far flung areas for a post surgery follow up appointment, the follow up visit will be done using telephone.

Also known as: Virtual Clinic, Phone Clinic, Remote Clinic

Teleclinic

Physical Clinic OTHER

Patients will have to travel to come physically to hospital to meet the operating surgeon.

Also known as: Traditional Clinic, Outpatient clinic, Standard Clinic

Traditional out patient clinic

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Breast Cancer.
• Written informed consent for participation in the trial.

You may not qualify if:

• Stage IV Breast Cancer.
• Chronic Pain.
• Breast Surgery with reconstruction.

Sponsors & Collaborators

• Shaukat Khanum Memorial Cancer Hospital & Research Centre: lead

Study Sites (1)

Shaukat Khanum memorial cancer hospital and research centre

Lahore, Punjab Province, 54782, Pakistan

Location

Related Publications (6)

• Khan NH, Duan SF, Wu DD, Ji XY. Better Reporting and Awareness Campaigns Needed for Breast Cancer in Pakistani Women. Cancer Manag Res. 2021 Mar 2;13:2125-2129. doi: 10.2147/CMAR.S270671. eCollection 2021.

  PMID: 33688255 BACKGROUND

• McMaster T, Wright T, Mori K, Stelmach W, To H. Current and future use of telemedicine in surgical clinics during and beyond COVID-19: A narrative review. Ann Med Surg (Lond). 2021 Jun;66:102378. doi: 10.1016/j.amsu.2021.102378. Epub 2021 May 8.

  PMID: 33996071 BACKGROUND

• Berg WT, Goldstein M, Melnick AP, Rosenwaks Z. Clinical implications of telemedicine for providers and patients. Fertil Steril. 2020 Dec;114(6):1129-1134. doi: 10.1016/j.fertnstert.2020.10.048.

  PMID: 33280717 BACKGROUND

• Nomura A, Tanigawa T, Muto T, Oga T, Fukushima Y, Kiyosue A, Miyazaki M, Hida E, Satake K. Clinical Efficacy of Telemedicine Compared to Face-to-Face Clinic Visits for Smoking Cessation: Multicenter Open-Label Randomized Controlled Noninferiority Trial. J Med Internet Res. 2019 Apr 26;21(4):e13520. doi: 10.2196/13520.

  PMID: 30982776 BACKGROUND

• Adams L, Lester S, Hoon E, van der Haak H, Proudman C, Hall C, Whittle S, Proudman S, Hill CL. Patient satisfaction and acceptability with telehealth at specialist medical outpatient clinics during the COVID-19 pandemic in Australia. Intern Med J. 2021 Jul;51(7):1028-1037. doi: 10.1111/imj.15205. Epub 2021 Jul 2.

  PMID: 34213046 BACKGROUND

• Orrange S, Patel A, Mack WJ, Cassetta J. Patient Satisfaction and Trust in Telemedicine During the COVID-19 Pandemic: Retrospective Observational Study. JMIR Hum Factors. 2021 Apr 22;8(2):e28589. doi: 10.2196/28589.

  PMID: 33822736 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Personal Satisfaction

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor determining the patient satisfaction will be blinded to the type of follow up. This will be ensured by restricting the information available to accessor to only the name and contact number of the patient. The assessor will therefore have no access to the electronic health record of the patient on HIS and will not be able to determine the type of follow up of the patient.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre-operative randomization will be carried out and patients will be allocated to either of the two groups this will be done by 'Computerized block randomization'.

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 25, 2022
• Study Start: January 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: December 10, 2023
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review of a research proposal. for more information PI can be contacted at awaiskanwal@gmail.com

Locations

PA (1)