Breast CancerBEAUTIFY-2NCT04957186
Personalized Follow-up After Breast Cancer Surgery Via Electronic Patient Reported Outcomes
A study testing Collection of postoperative information and Analysis of postoperative information collected from patients in people with Breast Cancer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Based on one focus group of caregivers and one group of patients treated by surgery for breast cancer this study is an attempt to identify the specific needs of this population and then develop the BEAUTIFY care pathway.This study aims to build a new multidisciplinary care pathway (BEAUTIFY = BrEast cAncer qUaliTy of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Collection of postoperative information and Analysis of postoperative information collected from patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 30 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female adult patients recruited from the gynecological or medical oncology department at Nîmes University Hospital who have undergone breast cancer surgery at least 6 months previous to their inclusion in the study and recruited during their post-operative follow-up consultations.
- All patients must have given written informed consent.
Who cannot join
- Patients who have not undergone breast cancer surgery.
- Patients Under the age of 18.
- Patients who have not given written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Multidisciplinary Care Pathway With Postoperative Follow-up Via Electronic Patient Reported Outcomes (ePRO) of Complications of Breast Cancer Surgery to Optimise Patients' Quality of Life.
Based on one focus group of caregivers and one group of patients treated by surgery for breast cancer this study is an attempt to identify the specific needs of this population and then develop the BEAUTIFY care pathway.This study aims to build a new multidisciplinary care pathway (BEAUTIFY = BrEast cAncer qUaliTy of lIfe aFter surgerY) with post-operative follow-up via electronic patient-reported outcomes of breast cancer surgery complications in order to optimize the quality of life of patients.
Read the detailed description
This study aims to build a new multidisciplinary care pathway (BEAUTIFY = BrEast cAncer qUaliTy of lIfe aFter surgerY) with post-operative follow-up via electronic patient-reported outcomes of breast cancer surgery complications in order to optimise the quality of life of patients.
The study will use focus groups of caregivers and patients treated by surgery for breast cancer to identify the specific needs of this population and then develop the BEAUTIFY care pathway.
In oncology, the monitoring of symptoms and treatment toxicities by caregivers is most often done through hetero-assessments. However, caregivers tend to underestimate them in relation to what the patient is experiencing. The discrepancy between the measures of side-effects recorded by the doctor's and patient's measures of side effects has indeed been demonstrated many times. For the patient's own view of his or her symptoms, health symptoms, health status, or quality of life (QoL), the (QoL), Patient Reported Outcomes (PRO) are increasingly used in oncology. They are defined as "any measure of the patient's health status reported directly by the patient, without interpretation by the physician or a third person". Several clinical trials have been conducted in recent years to assess the feasibility and value of collecting PROs in clinical routine in oncology, particularly through the use of electronic objects (ePROS). Improvements have been shown in the overall survival and QoL of patients followed by ePROS compared to conventionally followed patients, in patients on chemotherapy for metastatic cancer and in lung cancer surveillance.
Breast cancer surgery is responsible for specific acute (infection, haematoma, pain) and chronic (breast pain, axillary pain, arm pain, allodynia, paresthesia, retractile capsulitis of the shoulder post-mastectomy syndrome). Acute infections Post-operative infections may occur in 3 to 19% of 2020 RUBAN ROSE patients, especially after mastectomy. Chronic pain is reported in up to 70% of patients depending on the series. Post-mastectomy syndrome affects 20 to 50% of patients. These complications may be increased by radiotherapy. Many studies have shown that all of these chronic complications have a negative impact on the quality of life of patients and are responsible for depression and/or anxiety, sleep disorders and difficulties in returning to work.
Nevertheless, there are specific treatments (PEC) that can reduce these symptoms: physiotherapy, analgesic medication, analgesic patches, botulinum toxin injections, psychotherapy, etc. Several studies have shown that the earlier this treatment is undertaken, the lower the risk of complications.
It is therefore necessary to detect these complications as early as possible in order to manage them as quickly as possible. A close follow-up of specific symptoms of breast cancer surgery complications by ePRO could lead to earlier detection and management of these complications and thus improve patients' pain and quality of life (QoL).
We propose to develop an original care pathway focused on the collection of post-surgery complications in breast cancer via ePROs. The BEAUTIFY programme will be built by a committee of experts on the basis of reflections carried out within 2 focus groups: a group of 10 patients treated at Nîmes University Hospital for breast cancer; a group of caregivers from the University Hospitals of Nîmes, Montpellier and the ICM.
- Conditions
- Breast Cancer
- Being tested
- Collection of postoperative information, Analysis of postoperative information collected from patients
- Keywords
- Patient Reported Outcomes, Mastectomy, Postoperative Complications, Quality of Life, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of postoperative informationOther
The EORTC BR45 questionnaire will be used to gather information from patients regarding possible post-operative complications recorded via electronic patient-reported outcomes (pain, swelling, hypersensitivity etc.) as well as via the interviews with the state-registered coordinating nurse.
Analysis of postoperative information collected from patientsOther
All post-operative complications recorded via electronic patient-reported outcomes (pain, swelling, hypersensitivity etc.) as well as via the interviews with the state-registered coordinating nurse will be analyzed with the aim of proposing an appropriate care pathway.
| Study group | Role | What they receive |
|---|---|---|
| Patient Focus Group | Active comparator | Group consisting of 10 patients who have undergone breast cancer surgery (tumorectomy, mastectomy, lymph node dissection). Receives: Other: Collection of postoperative information |
| Caregiver Focus Group | Active comparator | Group consisting of 10 caregivers composed of 3 surgeons, 3 algologists, 3 oncologists and one study coordinator. Receives: Other: Analysis of postoperative information collected from patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific needs of patients who have undergone breast cancer surgery : ePRO results
Electronic Patient Reported Outcomes (ePROs) will be used to record postoperative complications of these patients who have undergone breast cancer surgery. Patients will have to express themselves according to items 47 - 53 of the EORTC QLQ-BR45 questionnaire containing questions related to the previous Week. The patient must answer on a scale of 1 to 4 in which 1 = Not at All, 2 = A little, 3 = Quite a Bit and 4 = Very Much
Measured: Up to 1 month following the end of radiotherapy treatment
Use of ePROs as a means of collecting post-surgical complications
Patients will be asked to give their appreciation of the use of Electronic Patient Reported Outcomes (ePROs) to record their postoperative complications: time taken, frequency and the type of interface used (ePRO or telephone)
Measured: Up to 1 month following the end of radiotherapy treatment
Results of the interview with the nurse for collecting post-surgical complications
Patients will be asked to give their appreciation of the interview with the nurse to record their postoperative complications.
Measured: Up to 1 month following the end of radiotherapy treatment
Actions desired in the event of an onset of complications in patients who have undergone breast cancer surgery.
Patients will be asked to express what actions they would like to be undertaken in the event of an onset of complications.
Measured: Up to 1 month following the end of radiotherapy treatment
Degree of anxiety/reassurance of patients who have undergone breast cancer surgery.
Patients will be asked to express their degree of anxiety or reassurance following their breast cancer surgery according to a Lickert scale of 1 to 5 in which 1 = completely reassured, 2 = reassured, 3 = indifferent, 4 = anxious and 5 = extremely anxious.
Measured: Up to 1 month following the end of radiotherapy treatment
Expectations of patients who have undergone breast cancer surgery.
Patients will be asked to express their expectations of the results of this information-gathering. These will be expressed on a Lickert scale of 1 to 5 in which 1 = not very hopeful, 2 = hopeful, 3 = indifferent, 4 = very hopeful, 5 = extremely hopeful.
Measured: Up to 1 month following the end of radiotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Apr 2021
- Primary completion31 May 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups in this study : one "Focus group" consisting of 10 patients who have undergone breast cancer surgery (tumorectomy, mastectomy, lymph node dissection), and one group of 10 caregivers consisting of 3 surgeons, 3 algologists, 3 oncologists and one study coordinator.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957186
- Sponsor's protocol ID
- Prix Ruban Rose/2021/FF-01
- Acronym
- BEAUTIFY-2
- Status last verified
- Sep 2022
- First submitted
- 22 Jun 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Di Maio M, Basch E, Bryce J, Perrone F. Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat Rev Clin Oncol. 2016 May;13(5):319-25. doi: 10.1038/nrclinonc.2015.222. Epub 2016 Jan 20.
PubMed 26787278Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
PubMed 28586821Kitzinger J, Barbour RS.Developing Focus Group Research: Politics, Theory and Practice. SAGE 1999
Hamood R, Hamood H, Merhasin I, Keinan-Boker L. Chronic pain and other symptoms among breast cancer survivors: prevalence, predictors, and effects on quality of life. Breast Cancer Res Treat. 2018 Jan;167(1):157-169. doi: 10.1007/s10549-017-4485-0. Epub 2017 Aug 31.
PubMed 28861642Montemurro F, Mittica G, Cagnazzo C, Longo V, Berchialla P, Solinas G, Culotta P, Martinello R, Foresto M, Gallizioli S, Calori A, Grasso B, Volpone C, Bertola G, Parola G, Tealdi G, Giuliano PL, Aglietta M, Ballari AM. Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer. JAMA Oncol. 2016 Apr;2(4):445-52. doi: 10.1001/jamaoncol.2015.4720.
PubMed 26720497Scaffidi M, Vulpiani MC, Vetrano M, Conforti F, Marchetti MR, Bonifacino A, Marchetti P, Saraceni VM, Ferretti A. Early rehabilitation reduces the onset of complications in the upper limb following breast cancer surgery. Eur J Phys Rehabil Med. 2012 Dec;48(4):601-11. Epub 2012 Apr 17.
PubMed 22510674
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multidisciplinary Care Pathway With Postoperative Follow-up Via Electronic Patient Reported Outcomes (ePRO) of Complications of Breast Cancer Surgery to Optimise Patients' Quality of Life.
- ClinicalTrials.gov ID
- NCT04957186
- Acronym / sponsor ID
- BEAUTIFY-2 / Prix Ruban Rose/2021/FF-01
- Conditions
- Breast Cancer
- Keywords
- Patient Reported Outcomes, Mastectomy, Postoperative Complications, Quality of Life, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Jul 2021 (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.
Based on one focus group of caregivers and one group of patients treated by surgery for breast cancer this study is an attempt to identify the specific needs of this population and then develop the BEAUTIFY care pathway.This study aims to build a new multidisciplinary care pathway (BEAUTIFY = BrEast cAncer qUaliTy of lIfe aFter surgerY) with post-operative follow-up via electronic patient-reported outcomes of breast cancer surgery complications in order to optimize the quality of life of patients.
Detailed description
This study aims to build a new multidisciplinary care pathway (BEAUTIFY = BrEast cAncer qUaliTy of lIfe aFter surgerY) with post-operative follow-up via electronic patient-reported outcomes of breast cancer surgery complications in order to optimise the quality of life of patients.
The study will use focus groups of caregivers and patients treated by surgery for breast cancer to identify the specific needs of this population and then develop the BEAUTIFY care pathway.
In oncology, the monitoring of symptoms and treatment toxicities by caregivers is most often done through hetero-assessments. However, caregivers tend to underestimate them in relation to what the patient is experiencing. The discrepancy between the measures of side-effects recorded by the doctor's and patient's measures of side effects has indeed been demonstrated many times. For the patient's own view of his or her symptoms, health symptoms, health status, or quality of life (QoL), the (QoL), Patient Reported Outcomes (PRO) are increasingly used in oncology. They are defined as "any measure of the patient's health status reported directly by the patient, without interpretation by the physician or a third person". Several clinical trials have been conducted in recent years to assess the feasibility and value of collecting PROs in clinical routine in oncology, particularly through the use of electronic objects (ePROS). Improvements have been shown in the overall survival and QoL of patients followed by ePROS compared to conventionally followed patients, in patients on chemotherapy for metastatic cancer and in lung cancer surveillance.
Breast cancer surgery is responsible for specific acute (infection, haematoma, pain) and chronic (breast pain, axillary pain, arm pain, allodynia, paresthesia, retractile capsulitis of the shoulder post-mastectomy syndrome). Acute infections Post-operative infections may occur in 3 to 19% of 2020 RUBAN ROSE patients, especially after mastectomy. Chronic pain is reported in up to 70% of patients depending on the series. Post-mastectomy syndrome affects 20 to 50% of patients. These complications may be increased by radiotherapy. Many studies have shown that all of these chronic complications have a negative impact on the quality of life of patients and are responsible for depression and/or anxiety, sleep disorders and difficulties in returning to work.
Nevertheless, there are specific treatments (PEC) that can reduce these symptoms: physiotherapy, analgesic medication, analgesic patches, botulinum toxin injections, psychotherapy, etc. Several studies have shown that the earlier this treatment is undertaken, the lower the risk of complications.
It is therefore necessary to detect these complications as early as possible in order to manage them as quickly as possible. A close follow-up of specific symptoms of breast cancer surgery complications by ePRO could lead to earlier detection and management of these complications and thus improve patients' pain and quality of life (QoL).
We propose to develop an original care pathway focused on the collection of post-surgery complications in breast cancer via ePROs. The BEAUTIFY programme will be built by a committee of experts on the basis of reflections carried out within 2 focus groups: a group of 10 patients treated at Nîmes University Hospital for breast cancer; a group of caregivers from the University Hospitals of Nîmes, Montpellier and the ICM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two groups in this study : one "Focus group" consisting of 10 patients who have undergone breast cancer surgery (tumorectomy, mastectomy, lymph node dissection), and one group of 10 caregivers consisting of 3 surgeons, 3 algologists, 3 oncologists and one study coordinator.
| Arm | Type | Receives |
|---|---|---|
| Patient Focus Group | Active comparator | Other: Collection of postoperative informationGroup consisting of 10 patients who have undergone breast cancer surgery (tumorectomy, mastectomy, lymph node dissection). |
| Caregiver Focus Group | Active comparator | Other: Analysis of postoperative information collected from patientsGroup consisting of 10 caregivers composed of 3 surgeons, 3 algologists, 3 oncologists and one study coordinator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female adult patients recruited from the gynecological or medical oncology department at Nîmes University Hospital who have undergone breast cancer surgery at least 6 months previous to their inclusion in the study and recruited during their post-operative follow-up consultations.
- All patients must have given written informed consent.
Key exclusion criteria (3 listed)
- Patients who have not undergone breast cancer surgery.
- Patients Under the age of 18.
- Patients who have not given written informed consent.
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 |
|---|---|---|
| Collection of postoperative informationThe EORTC BR45 questionnaire will be used to gather information from patients regarding possible post-operative complications recorded via electronic patient-reported outcomes (pain, swelling, hypersensitivity etc.) as well as via the interviews with the state-registered coordinating nurse. | Other | Patient Focus Group |
| Analysis of postoperative information collected from patientsAll post-operative complications recorded via electronic patient-reported outcomes (pain, swelling, hypersensitivity etc.) as well as via the interviews with the state-registered coordinating nurse will be analyzed with the aim of proposing an appropriate care pathway. | Other | Caregiver Focus Group |
Primary outcome
Specific needs of patients who have undergone breast cancer surgery : ePRO results
Time frame: Up to 1 month following the end of radiotherapy treatment
Electronic Patient Reported Outcomes (ePROs) will be used to record postoperative complications of these patients who have undergone breast cancer surgery. Patients will have to express themselves according to items 47 - 53 of the EORTC QLQ-BR45 questionnaire containing questions related to the previous Week. The patient must answer on a scale of 1 to 4 in which 1 = Not at All, 2 = A little, 3 = Quite a Bit and 4 = Very Much
Use of ePROs as a means of collecting post-surgical complications
Time frame: Up to 1 month following the end of radiotherapy treatment
Patients will be asked to give their appreciation of the use of Electronic Patient Reported Outcomes (ePROs) to record their postoperative complications: time taken, frequency and the type of interface used (ePRO or telephone)
Results of the interview with the nurse for collecting post-surgical complications
Time frame: Up to 1 month following the end of radiotherapy treatment
Patients will be asked to give their appreciation of the interview with the nurse to record their postoperative complications.
Actions desired in the event of an onset of complications in patients who have undergone breast cancer surgery.
Time frame: Up to 1 month following the end of radiotherapy treatment
Patients will be asked to express what actions they would like to be undertaken in the event of an onset of complications.
Degree of anxiety/reassurance of patients who have undergone breast cancer surgery.
Time frame: Up to 1 month following the end of radiotherapy treatment
Patients will be asked to express their degree of anxiety or reassurance following their breast cancer surgery according to a Lickert scale of 1 to 5 in which 1 = completely reassured, 2 = reassured, 3 = indifferent, 4 = anxious and 5 = extremely anxious.
Expectations of patients who have undergone breast cancer surgery.
Time frame: Up to 1 month following the end of radiotherapy treatment
Patients will be asked to express their expectations of the results of this information-gathering. These will be expressed on a Lickert scale of 1 to 5 in which 1 = not very hopeful, 2 = hopeful, 3 = indifferent, 4 = very hopeful, 5 = extremely hopeful.
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 28 Sep 2022.
- Background: PubMed 26787278Di Maio M, Basch E, Bryce J, Perrone F. Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat Rev Clin Oncol. 2016 May;13(5):319-25. doi: 10.1038/nrclinonc.2015.222. Epub 2016 Jan 20.
- Background: PubMed 28586821Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
- BackgroundKitzinger J, Barbour RS.Developing Focus Group Research: Politics, Theory and Practice. SAGE 1999
- Background: PubMed 28861642Hamood R, Hamood H, Merhasin I, Keinan-Boker L. Chronic pain and other symptoms among breast cancer survivors: prevalence, predictors, and effects on quality of life. Breast Cancer Res Treat. 2018 Jan;167(1):157-169. doi: 10.1007/s10549-017-4485-0. Epub 2017 Aug 31.
- Background: PubMed 26720497Montemurro F, Mittica G, Cagnazzo C, Longo V, Berchialla P, Solinas G, Culotta P, Martinello R, Foresto M, Gallizioli S, Calori A, Grasso B, Volpone C, Bertola G, Parola G, Tealdi G, Giuliano PL, Aglietta M, Ballari AM. Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer. JAMA Oncol. 2016 Apr;2(4):445-52. doi: 10.1001/jamaoncol.2015.4720.
- Background: PubMed 22510674Scaffidi M, Vulpiani MC, Vetrano M, Conforti F, Marchetti MR, Bonifacino A, Marchetti P, Saraceni VM, Ferretti A. Early rehabilitation reduces the onset of complications in the upper limb following breast cancer surgery. Eur J Phys Rehabil Med. 2012 Dec;48(4):601-11. Epub 2012 Apr 17.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of postoperative information and Analysis of postoperative information collected from patients in people with Breast Cancer, run by Centre Hospitalier Universitaire de Nīmes 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 2 inclusion and 3 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 28 Sep 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?
Specific needs of patients who have undergone breast cancer surgery : ePRO results (time frame: Up to 1 month following the end of radiotherapy treatment). The study lists 6 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 NCT04957186, which also lists 6 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 28 Sep 2022.