Breast CancerERAS-OncoReNCT03456167
Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery
A study testing RecoverWell mobile app for follow-up care in people with Breast Cancer and Gynecologic Cancer, run by Alberta Health Services, Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer
- What is being tested?
- RecoverWell mobile app for follow-up care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2019to 16 Apr 2021
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lack of fluency in English
- Lack of daily access to a smartphone where the app can be installed and operated.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
ERAS® (Enhanced Recovery After Surgery) protocols are evidence-based best practices bundled together to revolutionize pre-, intra-, and postoperative care resulting in better patient outcomes, increased patient postoperative satisfaction, and decreased healthcare costs. ERAS® protocols in breast reconstruction and gynecologic oncology have been developed by surgeons from the Tom Baker Cancer Centre and have the sanction of the international ERAS® Society for implementation globally.
As of 2015, the majority of Canadians owned a cell phone. Technological advances in these forms of communications have been shown to positively impact patient experience and reduce healthcare system burdens. Telemedicine delivered healthcare via smartphone apps now include platforms for encouraging healthy behaviors, monitoring chronic healthcare conditions, organizing personal healthcare records, and monitoring postsurgical wounds.
The proposed study would marry these two advances, ERAS® protocols and smartphone technology, to consider how the combination of these two approaches to postsurgical care might enhance patient satisfaction and convenience and minimize financial burden while providing high quality care and monitoring. Additionally, the combination of these approaches has the potential to benefit the healthcare system in a number of ways. By lessening surgery-related length of stay and reducing the number of postsurgical visits, an opportunity for cost-savings is evident. In addition, in a system that is troubled by long wait-times for some procedures, reducing lengths of stay and surgeons' postoperative clinical burden means more patients can be seen and treated in a timely fashion. This is a win-win for the healthcare system and patients. It provides structure for more efficiently caring for post-operative patients in a patient first manner that supports physicians, transforms care, and engages in responsible stewardship of healthcare resources according to the Foundational Strategies developed by Alberta Health Services.
The current study would assess the patient, physician, and healthcare system impact of combining ERAS® protocol-guided oncological surgery with postsurgical patient monitoring via a smartphone app that would lessen patients' postoperative burden when postoperative recovery is uneventful and would alert physicians earlier when things are not going well.
- Conditions
- Breast Cancer, Gynecologic Cancer
- Being tested
- RecoverWell mobile app for follow-up care
- Keywords
- telemedicine, mobile applications, ERAS, postoperative care, patient satisfaction, breast reconstruction, gynecologic oncology, mastectomy
- Medical subject headings
- Breast Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecoverWell mobile app for follow-up careOther
Also called QoC Health Inc. mobile application, RecoverWell
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6 weeks
Secondary outcomes (6)
Patient-borne Financial Costs of Followup Appointments
The costs related to attending one or more surgical followup appointments will be tracked. Participants will maintain a log of all associated expenses.
Measured: 6 weeks
Total Number of Contacts with Medical System Postoperatively
The total number of contacts with the healthcare system postoperatively will be tracked.
Measured: 6 weeks
Postoperative Complications
All complications occurring within the study period will be tracked. This information will be gathered.
Measured: 6 weeks
Adverse events NCI Version 3 / EORTC
Select adverse events including diarrhea, constipation, fever, urinary frequency/urgency, vaginal bleeding, wound complications, and fatigue will be tracked.
Measured: 6 weeks
Healthcare Professionals' Contact with Study Patients
The participating surgeons and study nurses will keep diaries of time spent on patient followup, including followup appointments, receiving and returning phone calls, and tame spent related to virtual monitoring via the smartphone app.
Measured: 6 weeks
Healthcare Professional Response to Virtual versus Traditional FollowUp Care
A telephone interview will be conducted with study surgeons and nursing staff at the end of the study to inquire into the impact on medical professionals conducting conventional versus virtual monitoring of postoperative patients.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start10 Jun 2019
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberta Health Services, Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Cancer Foundation
- Responsible party
- Principal investigator, Claire Temple-Oberle, Alberta Health Services, Calgary
- Investigators
- Claire Temple-Oberle, MD MSc FRCSC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456167
- Sponsor's protocol ID
- TomBakerCC
- Acronym
- ERAS-OncoRe
- Status last verified
- Apr 2021
- First submitted
- 4 Dec 2017
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26603969Nelson 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.
PubMed 26757238Temple-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.
PubMed 28445352Armstrong 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.
PubMed 28329223Temple-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.
PubMed 37043216
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery
- ClinicalTrials.gov ID
- NCT03456167
- Acronym / sponsor ID
- ERAS-OncoRe / TomBakerCC
- Conditions
- Breast Cancer, Gynecologic Cancer
- Keywords
- telemedicine, mobile applications, ERAS, postoperative care, patient satisfaction, breast reconstruction, gynecologic oncology, mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Alberta Health Services, CalgaryUniversity, hospital or other
- Collaborators
- Alberta Cancer Foundation
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 7 Mar 2018 (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.
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.
Detailed description
ERAS® (Enhanced Recovery After Surgery) protocols are evidence-based best practices bundled together to revolutionize pre-, intra-, and postoperative care resulting in better patient outcomes, increased patient postoperative satisfaction, and decreased healthcare costs. ERAS® protocols in breast reconstruction and gynecologic oncology have been developed by surgeons from the Tom Baker Cancer Centre and have the sanction of the international ERAS® Society for implementation globally.
As of 2015, the majority of Canadians owned a cell phone. Technological advances in these forms of communications have been shown to positively impact patient experience and reduce healthcare system burdens. Telemedicine delivered healthcare via smartphone apps now include platforms for encouraging healthy behaviors, monitoring chronic healthcare conditions, organizing personal healthcare records, and monitoring postsurgical wounds.
The proposed study would marry these two advances, ERAS® protocols and smartphone technology, to consider how the combination of these two approaches to postsurgical care might enhance patient satisfaction and convenience and minimize financial burden while providing high quality care and monitoring. Additionally, the combination of these approaches has the potential to benefit the healthcare system in a number of ways. By lessening surgery-related length of stay and reducing the number of postsurgical visits, an opportunity for cost-savings is evident. In addition, in a system that is troubled by long wait-times for some procedures, reducing lengths of stay and surgeons' postoperative clinical burden means more patients can be seen and treated in a timely fashion. This is a win-win for the healthcare system and patients. It provides structure for more efficiently caring for post-operative patients in a patient first manner that supports physicians, transforms care, and engages in responsible stewardship of healthcare resources according to the Foundational Strategies developed by Alberta Health Services.
The current study would assess the patient, physician, and healthcare system impact of combining ERAS® protocol-guided oncological surgery with postsurgical patient monitoring via a smartphone app that would lessen patients' postoperative burden when postoperative recovery is uneventful and would alert physicians earlier when things are not going well.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile app for follow-up care | Experimental | Other: RecoverWell mobile app for follow-up careParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Lack of fluency in English
- Lack of daily access to a smartphone where the app can be installed and operated.
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 |
|---|---|---|
| RecoverWell mobile app for follow-up careAlso: QoC Health Inc. mobile application, RecoverWellThe 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. | Other | Mobile app for follow-up care |
Primary outcome
Patient Satisfaction Questionnaire (PSQ-III) - Select Subscales
Time frame: 6 weeks
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.
Quality of Recovery 15
Time frame: 6 weeks
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 secondary outcomes
Patient-borne Financial Costs of Followup Appointments
Time frame: 6 weeks
Total Number of Contacts with Medical System Postoperatively
Time frame: 6 weeks
Postoperative Complications
Time frame: 6 weeks
Adverse events NCI Version 3 / EORTC
Time frame: 6 weeks
Healthcare Professionals' Contact with Study Patients
Time frame: 6 weeks
Healthcare Professional Response to Virtual versus Traditional FollowUp Care
Time frame: 6 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 21 Apr 2021.
- Background: PubMed 26603969Nelson 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.
- Background: PubMed 26757238Nelson 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.
- Background: PubMed 28445352Temple-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.
- Background: PubMed 28329223Armstrong 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.
- Derived from this study: PubMed 37043216Temple-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.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Claire Temple-Oberle, MD MSc FRCSC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RecoverWell mobile app for follow-up care in people with Breast Cancer and Gynecologic Cancer, run by Alberta Health Services, Calgary at 1 site in Canada.
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 3 inclusion and 2 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 21 Apr 2021. 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 Canada. 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 Questionnaire (PSQ-III) - Select Subscales (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT03456167, which also lists 5 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 21 Apr 2021.