Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000719235
Ethics application status
Approved
Date submitted
2/11/2017
Date registered
1/05/2018
Date last updated
15/09/2020
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of an early healthcare program and post-operative management of the upper limb to deal with associated complications in sentinel node surgery in women with breast cancer.
Scientific title
Effectiveness of an early healthcare program and post-operative management of the upper limb in women with breast cancer.
Secondary ID [1] 293271 0
None
Universal Trial Number (UTN)
U1111-1204-6180
Trial acronym
FISBRECA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 305332 0
Mobility 305333 0
Musculoskeletal pain 305334 0
Lymphedema 305335 0
Tissue adherences 305338 0
Condition category
Condition code
Cancer 304624 304624 0 0
Breast
Cardiovascular 304625 304625 0 0
Diseases of the vasculature and circulation including the lymphatic system
Musculoskeletal 304626 304626 0 0
Other muscular and skeletal disorders
Mental Health 304627 304627 0 0
Anxiety
Physical Medicine / Rehabilitation 304628 304628 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
24 hours after receiving surgical treatment, the relevant nurse addresses the patients who have been operated on to explain a series of precautions and recommendations for an adequate recovery, which include: advice on the incorporation of activity in daily life, care of surgical wounds, basic precautions, amongst which are: monitoring of temperature once a day and use of a recommended compressive bra without cups, hygiene, nutrition, and medicine prescribed by a doctor, as well as mention of certain actions to be avoided. All this information is contained in a document which the nurse will hand over on discharge.
The treatment group will receive a 4-week program on post-surgery sanitary education and upper limb management. The control group will only receive information 24 hours after the previously-mentioned operation on hospital grounds. Following the first session, the physiotherapist and patient will meet for further sessions depending on the patient's availability. One month after the initial physiotherapy treatment, the patient should have completed the program, which includes 6 sessions of one hour of duration, distributed in 3 phases :

Phase 1. Functional recovery. 3 Sessions.

The objective of this stage is to normalize muscular tone, improve lymphatic drainage and the complete mobility of the upper limb, minimizing any residual limitation.
In this stage, the following is carried out:
Perform a program of exercises, using oral and graphic information to explain exercises focusing on functional recovery and centered on lymphedema prevention, as well as postural hygiene and individualized exercises depending on the patient's progress.
These exercises consist of respiratory movements, particularly diaphragmatic breathing, and can be accompanied by upper limb movements, like stretching, and progressive assisted active exercises.
With these exercises, global functionality is obtained, as well as muscular work, minimizing paresthesia symptoms in the upper limbs.

Phase 2. Scar treatment. 2 sessions.

In this phase the following will be carried out:
- The first session will take place at least 2 days after the removal of stitches, where scar-cleaning will be shown to gently eliminate scabbing, and reduce marks (Vaseline, showering, drying, antiseptic application).
- The presence of hypertrophic or retractile scarring, or the appearance of clamps will be avoided.
- The normalization of surrounding areas, using massage therapy and kinesitherapy with the aim of giving elasticity and avoiding adhesions. Emphasis is put on hardened areas.
- Ensure that adequate interior clothing is worn, which fits but doesn't press excessively, because apart from discomfort it can provoke liquid accumulation in the sub-axillary area.
To end these sessions, underarm stretching will be performed, keeping in mind that discomfort may be produced, but not pain. The patient is asked to move the hand of the affected arm to the ear on the opposite side, and cause stretching by pushing the affected elbow backwards, or, starting in the same posture, gently apply pressure on the affected underarm with the opposite hand, to induce further elasticity.

Phase 3. Informative sessions. 1 session.

It is addressed to patients, family members and carers. A brief anatomical-physiological review of the lymphatic system will be carried out, explained in a simple way for people unfamiliar with the subject. Patients will learn what changes are produced following surgery, and events that could take place after such. They risk developing lymphedema.
They will be provided with information on how to improve management of the lymphatic system (avoiding deterioration), and to stimulate functionality, as well as how to avoid risks that can contribute to it's depletion, which can occasionally trigger lymphedema.
Intervention code [1] 299529 0
Rehabilitation
Comparator / control treatment
24 hours after receiving surgical treatment, the relevant nurse addresses the patients who have been operated on to explain a series of precautions and recommendations for an adequate recovery, which include: advice on the incorporation of activity in daily life, care of surgical wounds, basic precautions, amongst which are: monitoring of temperature once a day and use of a recommended compressive bra without cups, hygiene, nutrition, and medicine prescribed by a doctor, as well as mention of certain actions to be avoided. All this information is contained in a the "Medical Discharge Recommendatios Report" document which is readily available, and the nurse will hand over on discharge.
Control group
Active

Outcomes
Primary outcome [1] 303856 0
Change in range in joint mobility of the homolateral shoulder, assessed by a goniometry.
Timepoint [1] 303856 0
4 weeks after surgery
Secondary outcome [1] 340286 0
Proportion of participants with no hypertrophic scar, assessed by the POSAS scale.
Timepoint [1] 340286 0
4 weeks after surgery
Secondary outcome [2] 340287 0
Change in pain associated with movement of the upper homolateral limb, assessed by the VAS and SPADI scales.
Timepoint [2] 340287 0
4 weeks after surgery
Secondary outcome [3] 340288 0
Change in recovery muscular strength in the homolateral upper limb, assessed by dynamometry.
Timepoint [3] 340288 0
4 weeks after surgery
Secondary outcome [4] 340289 0
Proportion of participants with no appearance of myofascial adherence, assesseed by the MAP-BC scale.
Timepoint [4] 340289 0
4 weeks after surgery
Secondary outcome [5] 340290 0
Proportion of participants wth no appearance of a lymphatic cord on the damaged upper limb, assessed by palpation.
Timepoint [5] 340290 0
4 weeks after surgery
Secondary outcome [6] 340291 0
Change in women´s quality of life, assessd by the EORTC QLQ-BR23 scale.
Timepoint [6] 340291 0
4 weeks after surgery
Secondary outcome [7] 340293 0
Proportion of participants with no appearance of long-term lymphedema, assessed by telephone calls.
Timepoint [7] 340293 0
6 months after surgery

Eligibility
Key inclusion criteria
- Women between the ages of 25 and 65 years who have had sentinel node surgery.
- Women without a history of recurrences of breast cancer.
- Have medical authorization to participate.
- Have verbal communication capabilities.
Minimum age
25 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Existence of psychiatric disorders.
- Presence of relevant systemic conditions.
- Previous upper limb surgery or an existing condition that limits shoulder movement.
- Any medical condition which may limit participation in the proposed treatment program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/09/2018
Actual
3/09/2018
Date of last participant enrolment
Anticipated
22/02/2019
Actual
22/02/2019
Date of last data collection
Anticipated
25/08/2019
Actual
25/08/2019
Sample size
Target
84
Accrual to date
Final
84
Recruitment outside Australia
Country [1] 9333 0
Spain
State/province [1] 9333 0
Andalucía/Sevilla

Funding & Sponsors
Funding source category [1] 297899 0
Hospital
Name [1] 297899 0
Hospital Virgen del Rocío
Country [1] 297899 0
Spain
Primary sponsor type
Individual
Name
Esther Maria Medrano Sanchez
Address
Faculty of Nursery, Physiotherapy and Podiatry. Univesity of Sevilla (Spain)
Department of Physiotherapy
C/Avenzoar nº 6. 41009 Sevilla (Spain)
Country
Spain
Secondary sponsor category [1] 296953 0
None
Name [1] 296953 0
Address [1] 296953 0
Country [1] 296953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298949 0
CEI de los hospitales universitarios Vírgen Macarena-Virgen del Rocío
Ethics committee address [1] 298949 0
Ethics committee country [1] 298949 0
Spain
Date submitted for ethics approval [1] 298949 0
20/07/2017
Approval date [1] 298949 0
23/10/2017
Ethics approval number [1] 298949 0
1176-N-17

Summary
Brief summary
In the last few years, breast cancer surgical techniques are playing an important role in the maximum preservation of the breast, utilizing less harmful procedures for the patient, along with the integration of additional therapies. However, conventional surgery, as well as more invasive surgery, can produce post-operative problems.
Breast cancer surgery usually causes diverse fears and uncertainties in relation to post-operation healthcare, as well as to possible treatments for complications that may take place in the short, mid, and long terms. For this reason it is essential that health professionals inform about prevention and independent guidelines for the purpose of optimizing comprehensive care for patients, and to minimize possible post-surgery complications.
The health department of the autonomous Andalusian government published in 2002 the first edition of the process of integral assistance in breast cancer, with further editions published in 2005 and 2011. This present manual explains the approach taken by physiotherapists for possible post-operative complications, fundamentally prevention of the appearance of lymphedema, as well as other complications such as hypertrophic scars, retractable capsulitis or mechanical pain.

This study aims to demonstrate the effectiveness of an early program of sanitary education and post-surgery management of the upper-limb to deal with any complications associated with sentinel node surgery in women with breast cancer. Thus, it is intended to avoid this illness becoming chronic, which would imply long-term, as well as a reduction in quality of life.

Two operative hypothesis are established:

1.- An early educational healthcare program and post-operative management of the upper limb, applied to women operated on for breast cancer using the sentinel node technique, will diminish possible secondary physical ramifications after surgery, and is more effective than operations based on general recommendations.

2.-An early educational healthcare program and post-operative management of the upper limb, applied to women operated on for breast cancer, will improve the quality of life for these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78754 0
Dr Esther Maria Medrano Sanchez
Address 78754 0
Faculty of Nursery, Physiotherapy and Podiatry.
Department of Physiotherapy
University of Sevilla (Spain)

C/Avenzoar nº 6. 41009 Sevilla (Spain)
Country 78754 0
Spain
Phone 78754 0
+34954486521
Fax 78754 0
Email 78754 0
[email protected]
Contact person for public queries
Name 78755 0
Esther Maria Medrano Sanchez
Address 78755 0
Faculty of Nursery, Physiotherapy and Podiatry.
Department of Physiotherapy
University of Sevilla (Spain)

C/Avenzoar nº 6. 41009 Sevilla (Spain)
Country 78755 0
Spain
Phone 78755 0
+34954486521
Fax 78755 0
Email 78755 0
[email protected]
Contact person for scientific queries
Name 78756 0
Esther Maria Medrano Sanchez
Address 78756 0
Faculty of Nursery, Physiotherapy and Podiatry.
Department of Physiotherapy
University of Sevilla (Spain)

C/Avenzoar nº 6. 41009 Sevilla (Spain)
Country 78756 0
Spain
Phone 78756 0
+34954486521
Fax 78756 0
Email 78756 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
start date 01/10/2020
No end date determined
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5769Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePreliminary study on the effect of an early physical therapy intervention after sentinel lymph node biopsy: A multicenter non-randomized controlled trial.2021https://dx.doi.org/10.3390/ijerph18031275
EmbaseTranslation, Cross-Cultural Adaptation and Validation of the Myofascial Adhesions for Patients after Breast Cancer (MAP-BC) Evaluation Tool: Spanish Version.2022https://dx.doi.org/10.3390/ijerph19074337
N.B. These documents automatically identified may not have been verified by the study sponsor.