Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery

NCT03456167 | Completed

• 1 other identifier: TomBakerCC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess whether the implementation of a combination of ERAS (Enhanced Recovery After Surgery) protocols and postoperative followup via a smartphone app can offer 1) improved patient satisfaction, 2) virtual patient monitoring without an increase in postoperative emergency room visits, number and severity of postoperative complications, and readmissions, 3) decreased healthcare system costs, and 4) improved patient convenience and reduced patient financial costs. The study will be conducted among women having mastectomy, breast reconstruction, and gynecological oncology procedures. Half of the participants will be assigned to physician monitoring via a smartphone app and half will receive conventional care.

Conditions

Breast Cancer; Gynecologic Cancer

Keywords

telemedicine; mobile applications; ERAS; postoperative care; patient satisfaction; breast reconstruction; gynecologic oncology; mastectomy

Outcome Measures

Primary Outcomes (2)

• Patient Satisfaction Questionnaire (PSQ-III) - Select Subscales

  The PSQ-III is a validated questionnaire made up of several subscales and employing a "statement of opinion" response model of 5 response categories (strongly agree, agree, uncertain, disagree, strongly disagree). The subscales being employed in the current study include general satisfaction, communication with your doctor, time spent with doctor, financial aspects, and access/availability/convenience.

  6 weeks

• Quality of Recovery 15

  The Quality of Recovery 15 scale captures patient reported postoperative assessment of various dimensions of health including patient support, comfort, emotions, physical independence, and pain. Patients rate each of the 15 statements from 1 (never) to 10 (always).

  6 weeks

Secondary Outcomes (6)

• Patient-borne Financial Costs of Followup Appointments

  6 weeks

• Total Number of Contacts with Medical System Postoperatively

  6 weeks

• Postoperative Complications

  6 weeks

• Adverse events NCI Version 3 / EORTC

  6 weeks

• Healthcare Professionals' Contact with Study Patients

  6 weeks

Study Arms (2)

Mobile app for follow-up care

EXPERIMENTAL

Participants will use an app to submit photos of their surgical site, QoR15 scores, and EORTC selected adverse events scores daily for 2 weeks post-op \& weekly for another 4 weeks. Surgeons will use a wireless interface to access that data and monitor the patient's condition. Participants will complete questionnaires and keep diaries related to satisfaction, medical system encounters, surgical complications, followup-related financial costs, and telemedicine satisfaction at 2 \& 6 weeks post-op. They will attend prescribed follow-up appointments with their surgeon with the option to skip 1 or more follow-up appointments dependent on their recovery trajectory \& surgeon.

Other: RecoverWell mobile app for follow-up care

Conventional inperson followup care

NO INTERVENTION

The conventional follow-up care group will keep to conventional follow-up schedules of all surgeons involved. They will complete questionnaires and keep diaries related to satisfaction, medical system encounters, surgical complications, and followup-related financial costs at 2 \& 6 weeks post-op and attend all scheduled follow up appointments.

Interventions

RecoverWell mobile app for follow-up care OTHER

The mobile app follow-up care is an application that can be loaded onto a smartphone. It allows the patient to submit photos of their surgical site, QoR15 scores, and EORTC selected adverse events scores. The information collected is transmitted to members of the surgical team (i.e. the primary surgeon) and used to monitor recovery over the first 6 weeks following surgery.

Also known as: QoC Health Inc. mobile application, RecoverWell

Mobile app for follow-up care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 18 years of age undergoing breast reconstruction, mastectomy alone, and major gynecologic oncology procedures under ERAS protocols.
• Must own an Android or iOS smartphone, be familiar with basic smartphone technology, be willing to install the app on their phone, to have their phone doubly-encrypted, and to learn the app and camera features of the phone as needed for the study.
• Fluency in English

You may not qualify if:

• Lack of fluency in English
• Lack of daily access to a smartphone where the app can be installed and operated.

Sponsors & Collaborators

• Alberta Health Services, Calgary: lead
• Alberta Cancer Foundation: collaborator

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Related Publications (5)

• Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.

  PMID: 26603969 BACKGROUND

• Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.

  PMID: 26757238 BACKGROUND

• Temple-Oberle C, Shea-Budgell MA, Tan M, Semple JL, Schrag C, Barreto M, Blondeel P, Hamming J, Dayan J, Ljungqvist O; ERAS Society. Consensus Review of Optimal Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery (ERAS) Society Recommendations. Plast Reconstr Surg. 2017 May;139(5):1056e-1071e. doi: 10.1097/PRS.0000000000003242.

  PMID: 28445352 BACKGROUND

• Armstrong KA, Coyte PC, Brown M, Beber B, Semple JL. Effect of Home Monitoring via Mobile App on the Number of In-Person Visits Following Ambulatory Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 Jul 1;152(7):622-627. doi: 10.1001/jamasurg.2017.0111.

  PMID: 28329223 BACKGROUND

• Temple-Oberle C, Yakaback S, Webb C, Assadzadeh GE, Nelson G. Effect of Smartphone App Postoperative Home Monitoring After Oncologic Surgery on Quality of Recovery: A Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):693-699. doi: 10.1001/jamasurg.2023.0616.

  PMID: 37043216 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Patient Satisfaction

Interventions

Aftercare

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Claire Temple-Oberle, MD MSc FRCSC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Departments of Surgery and Oncology

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: March 7, 2018
• Study Start: June 10, 2019
• Primary Completion: April 16, 2021
• Study Completion: April 16, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)