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In this randomized controlled study, it was aimed to determine the effect of hilotherapy on quality of life and comfort level in the management of symptoms related to taxane-associated peripheral neuropathy in patients with breast cancer.
Hilotherapy Device Usage
Data Collection Tools of the Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Hilotherapy |
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| Control group | No Intervention | Non-hilotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hilotherapy | Device | Applying hilotherapy device at chemotherapy courses |
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| Measure | Description | Time Frame |
|---|---|---|
| Taxan-induced peripheric neuropathy score | Taxan-induced peripheric neuropathy score measured by "European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Related Peripheral Neuropathy Scale (EORTC QLQ-CIPN20)" The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item scale (EORTC QLQ-CIPN20) is a specific tool for determining TIPN symptoms. This patient-reported questionnaire comprises 20 items that can be divided into 3 subscales (sensory-9 items, motor-8 items, and autonomic-2 items. Item 39 is not included in any subscale and is analyzed separately as a single item). Responses follow a 4-point Likert scale:
| Will be assessed at the following time points: • Baseline -Week 0 (before chemo) • Week 4 (end of 4th chemo cycle) • Week 8 (end of 8th chemo cycle) • Week 12 (end of 12th chemotherapy cycle; last treatment) • Week 16 (4 weeks after completion of chemo) |
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| Measure | Description | Time Frame |
|---|---|---|
| General comfort level of patients | Confort level assessed by "General Comfort Scale Short Form". Is is a condensed version of the original Kolcaba General Comfort Questionnaire, designed to assess a patient's comfort levels across physical, psychospiritual, environmental, and sociocultural domains. The short form includes 28 items and uses a 6-point Likert scale. (1 = Strongly Disagree (least comfort) - 6 = Strongly Agree (most comfort)) Interpretation Higher scores (↑) = Better comfort (e.g., 70-100 = high comfort). Lower scores (↓) = Discomfort or unmet needs (e.g., <50 = significant discomfort). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nermin Ocaktan, Assist. Prof. | Contact | +90 533 737 33 06 | nermin.ocaktan@acibadem.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acibadem Altunizade Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Will be assessed at the following time points: • Baseline -Week 0 (before chemo) • Week 4 (end of 4th chemo cycle) • Week 8 (end of 8th chemo cycle) • Week 12 (end of 12th chemotherapy cycle; last treatment) • Week 16 (4 weeks after completion of chemo) |
| Acibadem Maslak Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
|