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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000554', 'term': 'Ambulatory Care Facilities'}], 'ancestors': [{'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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'."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2022-11-23', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': '3 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Post operative complications', 'timeFrame': '6 weeks', 'description': '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.\n\nGrade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.\n\nGrade 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'}, {'measure': 'Number of Emergency assessment room visits prior to follow up in Physical or Tele Clinic', 'timeFrame': '2 weeks', 'description': 'If a patient visits Emergency assessment room prior to follow up appointment it will be recorded as it can affect the patient satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient satisfaction', 'teleclinic', 'physical clinic', 'outpatient clinic', 'breast surgery', 'virtual clinics', 'randomized controlled trial', 'RCT', 'PSPVT Trial'], 'conditions': ['Satisfaction, Patient', 'Satisfaction']}, 'referencesModule': {'references': [{'pmid': '33688255', 'type': 'BACKGROUND', '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.'}, {'pmid': '33996071', 'type': 'BACKGROUND', '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.'}, {'pmid': '33280717', 'type': 'BACKGROUND', '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.'}, {'pmid': '30982776', 'type': 'BACKGROUND', '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.'}, {'pmid': '34213046', 'type': 'BACKGROUND', '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.'}, {'pmid': '33822736', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'The Purpose of this study is to measure patient satisfaction in standard Post- operative Breast Outpatient clinics versus teleclinics.\n\nPost 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.\n\nThis will be a single blinded randomized controlled trial.', 'detailedDescription': "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.\n\nAccess 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.\n\nTele 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.\n\nStudy Design: Randomized Controlled Trial\n\nSetting: Department of surgical oncology, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore.\n\nEnrolment: Patients will be enrolled pre-operatively, in the holding bay prior to the surgery.\n\nSample 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\n\nStudy Duration: Four months after the initiation of enrolment\n\nFollow up Schedule: 2 weeks after surgery, either in physical clinic or tele clinic\n\nRandomization: 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.\n\nBlinding: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Breast Cancer.\n* Written informed consent for participation in the trial.\n\nExclusion Criteria:\n\n* Stage IV Breast Cancer.\n* Chronic Pain.\n* Breast Surgery with reconstruction.'}, 'identificationModule': {'nctId': 'NCT05627193', 'acronym': 'PSPVT', 'briefTitle': 'Comparing Patient Satisfaction in Post-operative Breast Surgery Patients Having Physical Clinic and Tele Clinic Follow up: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Shaukat Khanum Memorial Cancer Hospital & Research Centre'}, 'officialTitle': 'Comparison of Patient Satisfaction in Post-operative Breast Surgery Patients Having Physical Clinic and Tele Clinic Follow up: A Randomized Controlled Trial (PSPVT Trial)', 'orgStudyIdInfo': {'id': 'IRB-22-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional out patient clinic', 'description': 'The volunteers of the study randomized into this group will be given traditional outpatient clinic follow up post surgery.', 'interventionNames': ['Other: Physical Clinic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Teleclinic', 'description': 'The Volunteer of the study randomized into this group will be given teleclinic appointment for follow up post surgery.', 'interventionNames': ['Other: Teleclinic']}], 'interventions': [{'name': 'Teleclinic', 'type': 'OTHER', 'otherNames': ['Virtual Clinic', 'Phone Clinic', 'Remote Clinic'], 'description': '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.', 'armGroupLabels': ['Teleclinic']}, {'name': 'Physical Clinic', 'type': 'OTHER', 'otherNames': ['Traditional Clinic', 'Outpatient clinic', 'Standard Clinic'], 'description': 'Patients will have to travel to come physically to hospital to meet the operating surgeon.', 'armGroupLabels': ['Traditional out patient clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54782', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Shaukat Khanum memorial cancer hospital and research centre', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaukat Khanum Memorial Cancer Hospital & Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Muhammad Awais Kanwal', 'investigatorAffiliation': 'Shaukat Khanum Memorial Cancer Hospital & Research Centre'}}}}