Breast CarcinomaNCT06783179
Postoperative Outcomes and Patient Satisfaction With Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
An observational study of Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates the postoperative outcomes of patients who are admitted to the Mayo Clinic Florida Care Hotel after mastectomy and tissue expander placement. At Mayo Clinic Florida, patients receiving low risk surgeries are often admitted to the hospital overnight for observation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2024to 16 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis.
Who may be able to join
- Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis followed by immediate tissue expander reconstruction who are either admitted to the Care Hotel post operatively, discharge home or admitted to the hospital.
Who cannot join
- Younger than 18 years old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maurician Buchanan contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Mauricia Buchanan, Buchanan.Mauricia@mayo.edu
About this study
Official title: Postoperative Outcomes and Patient Satisfaction for Patients Admitted to the Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
This study evaluates the postoperative outcomes of patients who are admitted to the Mayo Clinic Florida Care Hotel after mastectomy and tissue expander placement. At Mayo Clinic Florida, patients receiving low risk surgeries are often admitted to the hospital overnight for observation. A new model of delivering patient care was created at the Mayo Clinic Florida coined the "Care Hotel." This is a temporal, voluntary accommodation that offers patients a comfortable environment to receive nursing care before or after hospital treatment with in-person daytime monitoring and 24-hour virtual tele-monitoring in a hotel setting. This study evaluates post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.
Read the detailed description
PRIMARY OBJECTIVE:
- To investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.
OUTLINE: This is an observational study.
Patients have their medical records reviewed and may complete a survey on study.
- Conditions
- Breast Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients have their medical records reviewed and may complete a survey on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Recorded as incidence of hematoma, infection, readmission, and/or reoperation within 30 days of initial procedure.
Measured: Up to 30 days
Secondary outcomes (1)
Patient satisfaction
Assessed via voluntary survey given at first routine post operative visit to all patients who were admitted to the Care Hotel. The survey consists of 5 questions related to the Care Hotel Stay and one question related to pain level during the stay.. The 5 questions are answered on a scale ranging from 1-5 where 1=strongly disagree and 5=strongly agree, and the final questions is answered on a scale of 1-10 where 1=little pain and 10=worst pain ever experienced. There are also free-text sections for participants to indicate anything that impressed them about their experience with Care Hotel and/or anytihng that disappointed them about their experience.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start16 Dec 2024
- Primary completion16 Dec 2027 (estimated)
- Study completion16 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian D. Rinker, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783179
- Sponsor's protocol ID
- 24-006876
- Other IDs
- NCI-2024-10631, 24-006876
- Status last verified
- May 2026
- First submitted
- 14 Jan 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Outcomes and Patient Satisfaction for Patients Admitted to the Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
- ClinicalTrials.gov ID
- NCT06783179
- Acronym / sponsor ID
- 24-006876
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 16 Dec 2027 (estimated)
- Study completion
- 16 Dec 2027 (estimated)
- First posted
- 20 Jan 2025 (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 evaluates the postoperative outcomes of patients who are admitted to the Mayo Clinic Florida Care Hotel after mastectomy and tissue expander placement. At Mayo Clinic Florida, patients receiving low risk surgeries are often admitted to the hospital overnight for observation. A new model of delivering patient care was created at the Mayo Clinic Florida coined the "Care Hotel." This is a temporal, voluntary accommodation that offers patients a comfortable environment to receive nursing care before or after hospital treatment with in-person daytime monitoring and 24-hour virtual tele-monitoring in a hotel setting. This study evaluates post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.
Detailed description
PRIMARY OBJECTIVE:
- To investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.
OUTLINE: This is an observational study.
Patients have their medical records reviewed and may complete a survey on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients have their medical records reviewed and may complete a survey on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis.
Key inclusion criteria (1 listed)
- Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis followed by immediate tissue expander reconstruction who are either admitted to the Care Hotel post operatively, discharge home or admitted to the hospital.
Key exclusion criteria (1 listed)
- Younger than 18 years old.
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Complications
Time frame: Up to 30 days
Recorded as incidence of hematoma, infection, readmission, and/or reoperation within 30 days of initial procedure.
1 secondary outcome
Patient satisfaction
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Maurician Buchanan contact
Brian D. Rinker, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.