Breast NeoplasmCOTUKINCT04444882
Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care
An observational study of Breast Neoplasm, run by University Hospital, Grenoble at 1 site in France.
Trial summary
To make an inventory of the physiotherapeutic care and the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment. The investigators expect to see a lack of consultation of physiotherapists by patients despite a significant number of complications, impacting… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasm
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 28 Jan 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study involves breast cancer patients who have undergone the following treatment: lumpectomy, sentinel node and radiotherapy.
Who may be able to join
- Volunteer Patients
- Patients with a good command of French in order to understand the letter of information and the questionnaire.
- Patients treated at the "Couple Enfant Hospital" in Grenoble. We have chosen to take patients who have been operated on at least 3 months ago (average time of end of radiotherapy).
Who cannot join
- Patient having undergone a mastectomy or chemotherapy
- Patient with difficulties understanding, expressing or reading the French language
- Vulnerable patient or patient with impaired cognitive capacities (dementia, confusion)
- Patient subject to a legal protection measure or out of state to express her opposition (guardianship, curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
To make an inventory of the physiotherapeutic care and the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment.
The investigators expect to see a lack of consultation of physiotherapists by patients despite a significant number of complications, impacting the quality of life.
Read the detailed description
This study is observational and descriptive. For this purpose, patients meeting the inclusion and non-inclusion criteria can answer, if they wish, to an online questionnaire after having read the information and non-opposition letter.
- Conditions
- Breast Neoplasm
- Keywords
- postoperative complications, physiotherapy, rehabilitation, lumpectomy, sentinel node, radiotherapy
- Medical subject headings
- Breast Neoplasms, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of the physiotherapeutic care of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment
Answers to the questionnaire part 2 "physiotherapy care". Questions 17, 18, 19, 20, 21, 22, 24, 25, 26. (étude descriptive)
Measured: 10 minutes
Secondary outcomes (1)
Description of the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment
Answers to the questionnaire part 2 " post-operative complications " Questions 16, 23, 27, 28.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Jun 2021
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Bordin-Goffin, Study director, IFMK Saint Martin d'Hères
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444882
- Sponsor's protocol ID
- 38RC20.120
- Other IDs
- 2020-A00966-33
- Acronym
- COTUKI
- Status last verified
- Aug 2022
- First submitted
- 28 May 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care
- ClinicalTrials.gov ID
- NCT04444882
- Acronym / sponsor ID
- COTUKI / 38RC20.120
- Conditions
- Breast Neoplasm
- Keywords
- postoperative complications, physiotherapy, rehabilitation, lumpectomy, sentinel node, radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 24 Jun 2020 (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.
To make an inventory of the physiotherapeutic care and the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment.
The investigators expect to see a lack of consultation of physiotherapists by patients despite a significant number of complications, impacting the quality of life.
Detailed description
This study is observational and descriptive. For this purpose, patients meeting the inclusion and non-inclusion criteria can answer, if they wish, to an online questionnaire after having read the information and non-opposition letter.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study involves breast cancer patients who have undergone the following treatment: lumpectomy, sentinel node and radiotherapy.
Key inclusion criteria (3 listed)
- Volunteer Patients
- Patients with a good command of French in order to understand the letter of information and the questionnaire.
- Patients treated at the "Couple Enfant Hospital" in Grenoble. We have chosen to take patients who have been operated on at least 3 months ago (average time of end of radiotherapy).
Key exclusion criteria (4 listed)
- Patient having undergone a mastectomy or chemotherapy
- Patient with difficulties understanding, expressing or reading the French language
- Vulnerable patient or patient with impaired cognitive capacities (dementia, confusion)
- Patient subject to a legal protection measure or out of state to express her opposition (guardianship, curatorship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inventory of the physiotherapeutic care of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment
Time frame: 10 minutes
Answers to the questionnaire part 2 "physiotherapy care". Questions 17, 18, 19, 20, 21, 22, 24, 25, 26. (étude descriptive)
1 secondary outcome
Description of the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment
Time frame: 10 minutes
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 9 Aug 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Caroline Bordin-Goffin study director
IFMK Saint Martin d'Hères
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 Neoplasm, run by University Hospital, Grenoble at 1 site in France.
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 4 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 9 Aug 2022. 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 France. 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?
Inventory of the physiotherapeutic care of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment (time frame: 10 minutes). 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 9 Aug 2022.