Clinical trial NCT05627193: Comparing Patient Satisfaction in Post-operative Breast Surgery Patients Having Physical Clinic and Tele Clinic Follow up: A Randomized Controlled Trial
Official title: Comparison of Patient Satisfaction in Post-operative Breast Surgery Patients Having Physical Clinic and Tele Clinic Follow up: A Randomized Controlled Trial (PSPVT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction, Patient
Satisfaction
Keywords: patient satisfaction
teleclinic
physical clinic
outpatient clinic
breast surgery
virtual clinics
randomized controlled trial
RCT
PSPVT Trial
Lead sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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'.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The incidence of Breast Cancer is increasing in Pakistan and worldwide. In 2018, 2.1 million new cases were reported, with 627,000 deaths. Pakistan has the highest incidence of breast cancer among Asian countries: one in nine women is at risk of being diagnosed with breast cancer during their lifetime. According to the International Agency of Research on Cancer 2018 report, 34,066 new cases of breast cancer had been reported in Pakistani women. The Outpatient department Clinics are a standard part of routine follow-up for post-operative patients. Conventional Outpatient clinics incur hefty financial costs on patients living in distant areas.

Access to the telephone is increasing worldwide as technology advances and becomes more accessible to patients. Its use in healthcare settings is inevitable. In post-operative setting, remote consultation is feasible as the usual discussion is about the histopathology report of the procedure performed along with referrals for Adjuvant treatment. Nonetheless, there are some hesitations with this type of consultation. For instance, a visit to a physical clinic may help in early detection of potential complications which may be missed in remote consultation. Similarly, patients may not be satisfied with remote consultation alone.

Tele clinics, which became popular in the wake of Coronavirus disease pandemic, have been instrumental in improving healthcare delivery in Breast Surgery patients and this has been demonstrated by multiple studies but the data regarding patient satisfaction is not available in our population and needs to be studied.

Study Design: Randomized Controlled Trial

Setting: Department of surgical oncology, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore.

Enrolment: Patients will be enrolled pre-operatively, in the holding bay prior to the surgery.

Sample Size: A sample of 182 participants (91 in each group) has been determined for this study. The calculations were based on a 5% level of significance, a 95% confidence interval, 5% margin of error, pooled standard deviation of 3.01, and mean difference of satisfaction score as 1.1 and non-response rate of 5%. Sample size was calculated based on similar research results

Study Duration: Four months after the initiation of enrolment

Follow up Schedule: 2 weeks after surgery, either in physical clinic or tele clinic

Randomization: Pre-operative randomization will be carried out and patients will be allocated to either of the groups by selecting the name of the group to which patient has been randomized from a sealed envelope. The type of randomization would be 'Computerized block randomization'. Research Randomizer software, a free to use software will be used for this.

Blinding: 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 and will not be able to determine the type of follow up of the patient.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 3 weeks
Secondary outcomes:
measure: Post operative complications
timeFrame: 6 weeks
measure: Number of Emergency assessment room visits prior to follow up in Physical or Tele Clinic
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaukat Khanum memorial cancer hospital and research centre
state: Punjab
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.