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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.

Effectiveness of an early healthcare program and post-operative management of the upper limb in women with breast cancer.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000719235
Acronym
FISBRECA
Enrollment
84
Registered
2018-05-01
Start date
2018-09-03
Completion date
2019-02-22
Last updated
2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 ce

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.

Sponsors

Esther Maria Medrano Sanchez
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
25 Years to 90 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026