An interventional study of RecoverWell mobile app for follow-up care in Breast Cancer and Gynecologic Cancer, sponsored by Alberta Health Services, Calgary. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-21.
Sponsored by Alberta Health Services, Calgary · Not applicable, Interventional, and Health services research
Among 906 studies in Breast Neoplasms with a site in Canada — 141 open to participants now, 257 under way, 81 of them phase 3. Breast Neoplasms · Canada.
Among the 906 studies in Breast Neoplasms with a site in Canada, this one is the 533rd largest by enrollment of the 786 interventional ones that give a count, is one of 48 that started in 2019, is one of 203 with no phase, and was the 566th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →141 of the 906 studies in Breast Neoplasms with a site in Canada are open now. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in Canada
University Health Network, Toronto · Sites in Canada
Novartis Pharmaceuticals · Sites in Canada, United States, Australia and 1 more country
British Columbia Cancer Agency · Sites in Canada
Novartis Pharmaceuticals · Sites in Canada, United States, France and 6 more countries
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
906 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 129 · Phase 2 246 · Phase 3 255 · Phase 4 25
First in 1988; this study’s year is marked. 48 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 72 is close to the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 155 across the 786 interventional studies, 199 across the 110 observational. Of the 574 that completed or were terminated, 230 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
374 of 906 have an industry lead sponsor. The 10 most frequent:
Alberta Health Services, Calgary is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Alberta Health Services, Calgary has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
64 of the studies in Breast Neoplasms with a site in Canada that are under way reach primary completion within a year, 15 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
| NCT05038735Phase 3Novartis PharmaceuticalsStudy to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | 2027-01-28 |
| NCT04906395Phase 3Tolmar Inc.Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer | 2027-01-30 |
| NCT05696626Phase 3LeonaBioEvaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation | 2027-04 |
Among the 906 studies in Breast Neoplasms with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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
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.
Time frame: 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).
Time frame: 6 weeks
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.
Time frame: 6 weeks
Total Number of Contacts with Medical System Postoperatively
The total number of contacts with the healthcare system postoperatively will be tracked.
Time frame: 6 weeks
Postoperative Complications
All complications occurring within the study period will be tracked. This information will be gathered.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2019 to primary completion in Apr 2021, 22 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 22 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Alberta Health Services, Calgary