Clinical trial · Interventional
Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery
NCT03456167CI-TRIAL-00051371ERAS-OncoRecompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RecoverWell mobile app for follow-up care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mobile app for follow-up care
- description
- 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.
- interventionNames
- Other: RecoverWell mobile app for follow-up care
- type
- NO_INTERVENTION
- label
- Conventional inperson followup care
- description
- 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.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Lack of fluency in English * Lack of daily access to a smartphone where the app can be installed and operated.
References
Publications (5)
- BACKGROUNDNelson 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
- BACKGROUNDNelson 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
- BACKGROUNDTemple-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
- BACKGROUNDArmstrong 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
- DERIVEDTemple-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