Satisfaction, PatientPSPVTNCT05627193
Comparing Patient Satisfaction in Post-operative Breast Surgery Patients Having Physical Clinic and Tele Clinic Follow up: A Randomized Controlled Trial
A study testing Teleclinic and Physical Clinic in people with Satisfaction, Patient and Satisfaction, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Satisfaction, Patient, Satisfaction
- What is being tested?
- Teleclinic and Physical Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 10 Dec 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Breast Cancer.
- Written informed consent for participation in the trial.
Who cannot join
- Stage IV Breast Cancer.
- Chronic Pain.
- Breast Surgery with reconstruction.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaukat Khanum memorial cancer hospital and research centre
Lahore, Punjab Province, 54782
About this study
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)
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.
Read the 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.
- Conditions
- Satisfaction, Patient, Satisfaction
- Being tested
- Teleclinic, Physical Clinic
- Keywords
- patient satisfaction, teleclinic, physical clinic, outpatient clinic, breast surgery, virtual clinics, randomized controlled trial, RCT, PSPVT Trial
- Medical subject headings
- Patient Satisfaction, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleclinicOther
Also called Virtual Clinic, Phone Clinic, Remote Clinic
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.
Physical ClinicOther
Also called Traditional Clinic, Outpatient clinic, Standard Clinic
Patients will have to travel to come physically to hospital to meet the operating surgeon.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Teleclinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (2)
Post operative complications
These will be recorded as per Clavien Dindo Classification (CDC) Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetic, antipyretics, analgesics, diuretics and Electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.
Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.
Grade III Requiring surgical, endoscopic or radiological intervention Grade IIIa Intervention not under general anesthesia Grade IIIb Intervention under general anesthesia Grade IV Life-threatening complications (including CNS complications) * requiring IC/ICU-management Grade IVa Single organ dysfunction (including dialysis) Grade IVb Multi-organ Dysfunction Grade V Death of a patient
Measured: 6 weeks
Number of Emergency assessment room visits prior to follow up in Physical or Tele Clinic
If a patient visits Emergency assessment room prior to follow up appointment it will be recorded as it can affect the patient satisfaction.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Jan 2023
- Primary completion31 Aug 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Satisfaction, PatientStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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'.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Muhammad Awais Kanwal, Shaukat Khanum Memorial Cancer Hospital & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627193
- Sponsor's protocol ID
- IRB-22-34
- Acronym
- PSPVT
- Status last verified
- Apr 2025
- First submitted
- 15 Nov 2022
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with interests in patient satisfaction. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
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.
PubMed 33688255McMaster 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.
PubMed 33996071Berg 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.
PubMed 33280717Nomura 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.
PubMed 30982776Adams 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.
PubMed 34213046Orrange 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.
PubMed 33822736
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05627193
- Acronym / sponsor ID
- PSPVT / IRB-22-34
- Conditions
- Satisfaction, Patient, Satisfaction
- Keywords
- patient satisfaction, teleclinic, physical clinic, outpatient clinic, breast surgery, virtual clinics, randomized controlled trial, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 25 Nov 2022 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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'.
| Arm | Type | Receives |
|---|---|---|
| Traditional out patient clinic | Active comparator | Other: Physical ClinicThe volunteers of the study randomized into this group will be given traditional outpatient clinic follow up post surgery. |
| Teleclinic | Active comparator | Other: TeleclinicThe Volunteer of the study randomized into this group will be given teleclinic appointment for follow up post surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Breast Cancer.
- Written informed consent for participation in the trial.
Key exclusion criteria (3 listed)
- Stage IV Breast Cancer.
- Chronic Pain.
- Breast Surgery with reconstruction.
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 |
|---|---|---|
| TeleclinicAlso: Virtual Clinic, Phone Clinic, Remote ClinicInstead 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. | Other | Teleclinic |
| Physical ClinicAlso: Traditional Clinic, Outpatient clinic, Standard ClinicPatients will have to travel to come physically to hospital to meet the operating surgeon. | Other | Traditional out patient clinic |
Primary outcome
Patient Satisfaction
Time frame: 3 weeks
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.
2 secondary outcomes
Post operative complications
Time frame: 6 weeks
Number of Emergency assessment room visits prior to follow up in Physical or Tele Clinic
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Background: PubMed 33688255Khan 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.
- Background: PubMed 33996071McMaster 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.
- Background: PubMed 33280717Berg 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.
- Background: PubMed 30982776Nomura 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.
- Background: PubMed 34213046Adams 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.
- Background: PubMed 33822736Orrange 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.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with interests in patient satisfaction. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleclinic and Physical Clinic in people with Satisfaction, Patient and Satisfaction, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 23 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Satisfaction (time frame: 3 weeks). 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 NCT05627193, which also lists 6 linked publications.
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 23 Apr 2025.