Heart Pillow - Chemoteraphy

NCT06986213 | Enrolling By Invitation

• 1 other identifier: University of Évora-ULSAC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation Program; Breast Cancer Patients

Keywords

Breast cancer; nursing rehabilitation care; self-care; upper limb

Outcome Measures

Primary Outcomes (1)

• Recovering mobility in the homolateral upper limb

  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.

  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

Other Outcomes (2)

• Upper limb lymphoedema

  Every 3 weeks until the end of chemotherapy treatment. Time Points: T0-first evaluation appointment (chemotherapy); T1 at Tx-evaluation every 3 weeks

• Sleep quality

  At the start of chemotherapy after surgery, until the end of the treatment cycle (approximately 3 months). Time Points: T0-first evaluation appointment (chemotherapy); T1 at Tx-evaluation every 3 weeks

Study Arms (1)

Heart Pillow Group

EXPERIMENTAL

Behavioral: Heart Pillow Intervention

Interventions

Heart Pillow Intervention BEHAVIORAL

Self-Care: Teach techniques to perform diminished or dependent self-care. Demonstrate assistive devices for self-care. Teach and train techniques and the use of assistive devices. Scare Tissue: Perform massage techniques on scar tissue: gliding and friction. Teach and train massage technique.

Heart Pillow Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patients undergoing chemotherapy after surgery.

You may not qualify if:

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

Sponsors & Collaborators

• José Manuel Afonso Moreira: lead
• Unidade Local de Saúde do Alentejo Central: collaborator
• University of Évora: collaborator

Study Sites (1)

Évora

Evora, Portugal

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Isabel Bico, PhD

  University of Évora

  PRINCIPAL INVESTIGATOR

• Paula Sousa, MsC

  ULSAC

  STUDY CHAIR

• Sofia Braga, MsC

  ULSAC

  STUDY CHAIR

• Carmelinda Talhinhas

  ULSAC

  STUDY CHAIR

• José Moreira

  University of Évora

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Participants are assessed using the instruments and techniques already mentioned. The data are analyzed from a clinical perspective to define and validate diagnoses. Validation is carried out by a rehabilitation nursing specialist. The diagnoses are in accordance with the International Classification for Nursing Practice: \- Committed eating self-care. Self-care transfer committed Self-care grooming (toilet) committed Compromised self-care (going to the bathroom, bladder and bowel control) Compromised hygiene self-care Self-care walking (mobility and going up/down stairs), compromised Inadequate scar tissue The intervention is teaching and training with assistive devices for self-care and teaching and training in massage technique. Progress monitoring is carried out every 2 or 3 weeks, coinciding with the chemotherapy treatment plan.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 22, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)