Skip to main content
Clinical Trials/NCT06986213
NCT06986213Enrolling By InvitationNot Applicable

Heart Pillow - Chemoteraphy

José Manuel Afonso Moreira1 site in 1 country60 target enrollmentStarted: March 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Recovering mobility in the homolateral upper limb

Study Overview

Brief Summary

Breast cancer is a health problem with increasing prevalence, along with more effective therapeutic responses and less mutilating surgeries. The process of caring for patients crosses different levels: the diagnostic phase, which is mostly outpatient, the surgical treatment phase, which is mostly short-term inpatient, and the medical treatment phase in a day hospital. An integrated and structured care model based on specialized nursing skills can help improve self-care, quality of life and well-being.

Detailed Description

Detailed description 1:

The intervention project is developed during the medical treatment phase and is designed to reconcile multidisciplinary interventions and accompany patients during this phase. Self-care is the central concept of the project, it is multidimensional but the approach in the project is centered on a disease process and people-centered healthcare responses. It is estimated that the early initiation of activities that promote the recovery of self-care and the reduction of complications resulting from immobility of the homolateral upper limb or the formation of scar adhesions may reduce the time and costs dedicated to rehabilitation care at a later stage.

The study includes personalized interventions, carried out with patients every three weeks, from the beginning until discharge from chemotherapy treatment. Once informed consent has been obtained, the first session carried out by the rehabilitation nurse includes the patient's assessment, the allocation of the Heart pillow with a teaching session and training for its use. The first assessment includes: sociodemographic and health characterization, assessment of symptoms and quality of life (EORTC QLQ-C3 version 3.0 and EORTC QLQ-Br23), independence in ADL (Barthel Scale), upper limb functionality (DASH Portuguese version), sleep quality (PSQI-PT), assessment of grip strength by dynamometry (Dynamometry), assessment of the range of movement of the upper limbs by goniometry and assessment of the presence of edema by measuring the limb circumference. The data collected at this stage are analyzed from a clinical perspective to define the individual care plan: Intervention in self-care and the symptoms mentioned.

Every 3 weeks, the assessment of symptoms, independence of daily activities, strength, range of movement and lymphedema are repeated, providing data on progress but also for assessing the individual care plan from which teaching and training interventions are carried out, appropriate for each participant.

The final assessment coincides with the completion of the last chemotherapy treatment session, the assessments of the intermediate phase are repeated and independence in instrumental activities and sleep quality are assessed.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Breast cancer patients undergoing chemotherapy after surgery.

Exclusion Criteria

  • •Patients with breast cancer who did not undergo surgical treatment.

Arms & Interventions

Heart Pillow Group

Experimental

Intervention: Heart Pillow Intervention (Behavioral)

Outcomes

Primary Outcomes

Recovering mobility in the homolateral upper limb

Time Frame: Every 3 weeks until the end of chemotherapy treatment. The result of the evaluation is translated into: Kgf (Muscle strength); Degrees (goniometry). Time Points: T0-first evaluation appointment (chemotherapy); T1 at Tx-evaluation every 3 weeks

The measures used are functional assessment of the upper limb with the Disabilities of the Arm, Shoulder and Hand (DASH-PT) scale: 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). Assessment of muscle strength with dynamometry and assessment of amplitude by goniometry.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
José Manuel Afonso Moreira
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

José Manuel Afonso Moreira

Clinical Professor

University of Évora

Study Sites (1)

Loading locations...

Similar Trials