Rehabilitation ProgramHepi_QtNCT06986213
Heart Pillow - Chemoteraphy
A study testing Heart Pillow Intervention in people with Rehabilitation Program and Breast Cancer Patients, run by José Manuel Afonso Moreira at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rehabilitation Program, Breast Cancer Patients
- What is being tested?
- Heart Pillow Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients undergoing chemotherapy after surgery.
Who cannot join
- Patients with breast cancer who did not undergo surgical treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
Objectives:
Analyze the effects of the Heart Pillow in relieving symptoms. Analyze the results of self-care teaching and training in the recovery of functional independence of breast cancer patients treated with surgery, during chemotherapy treatment.
Characterize the evolution of symptoms during chemotherapy treatment.
Detailed Description 2:
Patient participation is obtained through informed consent. The heart-shaped pillow is supplied with a user manual and instructions are provided on how to use it. The manual was created by researchers, based on the results of the impact study with 93 women (awaiting publication).
After surgery and the resumption of chemotherapy treatments, participants are evaluated in the office (privacy and confidentiality) with the application of scales and questionnaires validated for the population studied and with techniques by a specialist in rehabilitation nursing (Goniometry and dynamometry) and evaluation of the surgical scar.
The EORTC QLQ-C3 version 3.0 and EORTC QLQ-Br23 questionnaires assess the presence and intensity of symptoms associated with breast cancer treatment and also the perception of quality of life. The Barhtel index provides data on the patient's independence in 10 activities of daily living (self-care). The Portuguese version of DASH identifies activities that are limited in the upper limb ipsilateral to the surgery. Sleep quality (PSQI-PT) is a study variable that emerged from research findings on the impact of pillows on women's symptoms and well-being. Data on sleep quality are collected at the beginning and end of the study.
Muscle strength, range of motion in the upper limb, and scar status are physiological variables that may be altered and may underlie limitations or dependence in performing self-care.
Chemotherapy treatment is performed every 3 weeks and assessments are also repeated with: Barthel Index, EORTC QLQ-C3 version 3.0 and EORTC QLQ-Br23, DASH, dynamometry, goniometry and scar assessment.
In all assessments, nursing diagnoses are defined and validated in accordance with the International Classification for Nursing Practice. The assessment data is analyzed and validated by experts to attest to its adequacy. For each diagnosis, an intervention plan is created that includes demonstration of techniques and support devices for self-care with a moderate or severe degree of dependence, teaching and training in techniques and use of devices. In the presence of the diagnosis of "Inadequate scar tissue" the intervention plan includes demonstration, teaching and training of massage technique.
At the end of chemotherapy treatment, the entire initial assessment is repeated. The data is recorded on specific, coded forms, and the information is transferred to an encrypted computer file, with access restricted to researchers. The file is destroyed after the study data has been published and disseminated.
- Conditions
- Rehabilitation Program, Breast Cancer Patients
- Being tested
- Heart Pillow Intervention
- Keywords
- Breast cancer, nursing rehabilitation care, self-care, upper limb
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Pillow InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Heart Pillow Group | Experimental | Not described Receives: Behavioral: Heart Pillow Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation ProgramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- José Manuel Afonso Moreira
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde do Alentejo Central, University of Évora
- Responsible party
- Sponsor-investigator, José Manuel Afonso Moreira, University of Évora
- Investigators
- Isabel Bico, PhD, Principal investigator, University of ÉvoraPaula Sousa, MsC, Study chair, ULSACSofia Braga, MsC, Study chair, ULSACCarmelinda Talhinhas, Study chair, ULSACJosé Moreira, Study chair, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986213
- Sponsor's protocol ID
- University of Évora-ULSAC
- Acronym
- Hepi_Qt
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' personal data will not be shared, as recommended by the ethics committee. All data will be anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Pillow - Chemoteraphy
- ClinicalTrials.gov ID
- NCT06986213
- Acronym / sponsor ID
- Hepi_Qt / University of Évora-ULSAC
- Conditions
- Rehabilitation Program, Breast Cancer Patients
- Keywords
- Breast cancer, nursing rehabilitation care, self-care, upper limb
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- José Manuel Afonso MoreiraUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde do Alentejo Central, University of Évora
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Objectives:
Analyze the effects of the Heart Pillow in relieving symptoms. Analyze the results of self-care teaching and training in the recovery of functional independence of breast cancer patients treated with surgery, during chemotherapy treatment.
Characterize the evolution of symptoms during chemotherapy treatment.
Detailed Description 2:
Patient participation is obtained through informed consent. The heart-shaped pillow is supplied with a user manual and instructions are provided on how to use it. The manual was created by researchers, based on the results of the impact study with 93 women (awaiting publication).
After surgery and the resumption of chemotherapy treatments, participants are evaluated in the office (privacy and confidentiality) with the application of scales and questionnaires validated for the population studied and with techniques by a specialist in rehabilitation nursing (Goniometry and dynamometry) and evaluation of the surgical scar.
The EORTC QLQ-C3 version 3.0 and EORTC QLQ-Br23 questionnaires assess the presence and intensity of symptoms associated with breast cancer treatment and also the perception of quality of life. The Barhtel index provides data on the patient's independence in 10 activities of daily living (self-care). The Portuguese version of DASH identifies activities that are limited in the upper limb ipsilateral to the surgery. Sleep quality (PSQI-PT) is a study variable that emerged from research findings on the impact of pillows on women's symptoms and well-being. Data on sleep quality are collected at the beginning and end of the study.
Muscle strength, range of motion in the upper limb, and scar status are physiological variables that may be altered and may underlie limitations or dependence in performing self-care.
Chemotherapy treatment is performed every 3 weeks and assessments are also repeated with: Barthel Index, EORTC QLQ-C3 version 3.0 and EORTC QLQ-Br23, DASH, dynamometry, goniometry and scar assessment.
In all assessments, nursing diagnoses are defined and validated in accordance with the International Classification for Nursing Practice. The assessment data is analyzed and validated by experts to attest to its adequacy. For each diagnosis, an intervention plan is created that includes demonstration of techniques and support devices for self-care with a moderate or severe degree of dependence, teaching and training in techniques and use of devices. In the presence of the diagnosis of "Inadequate scar tissue" the intervention plan includes demonstration, teaching and training of massage technique.
At the end of chemotherapy treatment, the entire initial assessment is repeated. The data is recorded on specific, coded forms, and the information is transferred to an encrypted computer file, with access restricted to researchers. The file is destroyed after the study data has been published and disseminated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Heart Pillow Group | Experimental | Behavioral: Heart Pillow Intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer patients undergoing chemotherapy after surgery.
Key exclusion criteria (1 listed)
- Patients with breast cancer who did not undergo surgical treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Pillow InterventionSelf-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. | Behavioural | Heart Pillow Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Participants' personal data will not be shared, as recommended by the ethics committee. All data will be anonymized.
Related trials for Rehabilitation Program
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Evidence-based, Customized, Motion-recognition Rehabilitation System Development for Bed-ridden Patients - Validation of Effectiveness: Rehabit: Swim
ICU-acquired Weakness
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Recruiting
Cycling Within an Interactive and Immersive Virtual Environment During Critical Illness: a Patient-centred Approach for Lower Limb Rehabilitation
Critical Illness
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabel Bico, PhD principal investigator
University of Évora
Paula Sousa, MsC study chair
ULSAC
Sofia Braga, MsC study chair
ULSAC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Pillow Intervention in people with Rehabilitation Program and Breast Cancer Patients, run by José Manuel Afonso Moreira at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.