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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]

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

Mobility

Musculoskeletal pain

Lymphedema

Tissue adherences

Condition category

Condition code

Cancer

Breast

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Musculoskeletal

Other muscular and skeletal disorders

Mental Health

Anxiety

Physical Medicine / Rehabilitation

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]

Rehabilitation

Comparator / control treatment

Control group

Active

Outcomes

Primary outcome [1]

Change in range in joint mobility of the homolateral shoulder, assessed by a goniometry.

Timepoint [1]

4 weeks after surgery

Secondary outcome [1]

Proportion of participants with no hypertrophic scar, assessed by the POSAS scale.

Timepoint [1]

4 weeks after surgery

Secondary outcome [2]

Change in pain associated with movement of the upper homolateral limb, assessed by the VAS and SPADI scales.

Timepoint [2]

4 weeks after surgery

Secondary outcome [3]

Change in recovery muscular strength in the homolateral upper limb, assessed by dynamometry.

Timepoint [3]

4 weeks after surgery

Secondary outcome [4]

Proportion of participants with no appearance of myofascial adherence, assesseed by the MAP-BC scale.

Timepoint [4]

4 weeks after surgery

Secondary outcome [5]

Proportion of participants wth no appearance of a lymphatic cord on the damaged upper limb, assessed by palpation.

Timepoint [5]

4 weeks after surgery

Secondary outcome [6]

Change in women´s quality of life, assessd by the EORTC QLQ-BR23 scale.

Timepoint [6]

4 weeks after surgery

Secondary outcome [7]

Proportion of participants with no appearance of long-term lymphedema, assessed by telephone calls.

Timepoint [7]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Andalucía/Sevilla

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Hospital Virgen del Rocío

Address [1]

Avda. Manuel Siurot, s/n
41013, Seville

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CEI de los hospitales universitarios Vírgen Macarena-Virgen del Rocío

Ethics committee address [1]

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

20/07/2017

Approval date [1]

23/10/2017

Ethics approval number [1]

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

Dr Esther Maria Medrano Sanchez

Address

Faculty of Nursery, Physiotherapy and Podiatry.
Department of Physiotherapy
University of Sevilla (Spain)

C/Avenzoar nº 6. 41009 Sevilla (Spain)

Country

Spain

Phone

+34954486521

Fax

[email protected]

Contact person for public queries

Name

Esther Maria Medrano Sanchez

Address

Faculty of Nursery, Physiotherapy and Podiatry.
Department of Physiotherapy
University of Sevilla (Spain)

C/Avenzoar nº 6. 41009 Sevilla (Spain)

Country

Spain

Phone

+34954486521

Fax

[email protected]

Contact person for scientific queries

Name

Esther Maria Medrano Sanchez

Address

Faculty of Nursery, Physiotherapy and Podiatry.
Department of Physiotherapy
University of Sevilla (Spain)

C/Avenzoar nº 6. 41009 Sevilla (Spain)

Country

Spain

Phone

+34954486521

Fax

[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.	Type	Citation	Link	Email	Other Details	Attachment
5769	Study protocol			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Preliminary study on the effect of an early physical therapy intervention after sentinel lymph node biopsy: A multicenter non-randomized controlled trial.	2021	https://dx.doi.org/10.3390/ijerph18031275
Embase	Translation, Cross-Cultural Adaptation and Validation of the Myofascial Adhesions for Patients after Breast Cancer (MAP-BC) Evaluation Tool: Spanish Version.	2022	https://dx.doi.org/10.3390/ijerph19074337

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically