Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT05627193
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Patient Satisfaction in Post-operative Breast Surgery Patients Having Physical Clinic and Tele Clinic Follow up: A Randomized Controlled Trial
Sponsor:
Shaukat Khanum Memorial Cancer Hospital & Research Centre
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSPVT
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: