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Peripheral neuropathy from paclitaxel is a cause for concern. This situation also affects the patient, family and healthcare professionals. All health personnel are responsible for its care. With this study, it will be possible to create evidence for nursing practices and increase the quality of life by relieving symptoms.
Unique value of the project: Chemotherapy Induced Peripheral Neuropathy (CIPN) is one of the most common side effects of chemotherapeutic agents. CIPN is a frequently dose-limiting neurotoxicity that causes significant deterioration in patients' quality of life. The development of chemotherapy-induced peripheral neuropathy has not been fully explained. Due to the increasing survival rates of cancer patients, paclitaxel-induced neurotoxicity has become a growing epidemiological problem. In a systematic review to identify metabolic and lifestyle risk factors for chemotherapy-induced peripheral neuropathy in patients treated with taxane and platinum; it has been shown that the overall incidence of neuropathy varies between 16.9% and 89.4%. However, growing evidence suggests that exercise may help reduce CIPN. Specifically, the most evidence supports that moderate to vigorous aerobic exercise combined with strength and/or balance training in the clinic and at home can reduce CIPN during and after chemotherapy treatment. Physical exercise can attenuate CIPN through its effect on blood circulation/oxidative stress, inflammation, neurotransmitters, endogenous opioids, growth factors, neuroplasticity and coping, symptom interaction mechanisms. Treatment with taxane-containing chemotherapy regimens is crucial to improve overall and disease-free survival in patients with early-stage invasive breast cancer. However, taxane treatment may cause pain. Although the incidence of taxane-induced pain is inconsistent in the literature, nonspecific pain has been described in 50-78% of patients receiving taxane therapy. Myalgia and/or arthralgia experienced by patients receiving taxane-based chemotherapy may result in impaired mobility secondary to limitation of joint function, and the experience of pain may affect physical function. The beginnings of nursing theories were developed to form the foundations of nursing science through the production of profession-specific knowledge. Theories consist of concepts and statements that aim to explain or categorize phenomena related to a field of knowledge. Theory of Unpleasant Symptoms (TOUS) arises from the belief that there are common points between different symptoms. This theory allows nurses to know different symptom groups so they can recommend non-pharmacological interventions to patients.
Method: The project was planned as a prospective, single-blind, randomized controlled experimental type.
Management: Motivational interviewing is an important component of the walking intervention. Specific objectives are to evaluate the impact of gait intervention with Motivational interviewing on; CIPN severity and To evaluate the effect of walking exercise alone on arthralgia-myalgia at 12 weeks compared with standard training in breast cancer patients receiving paclitaxel.
Application
Control Group
Widespread effect: This study will contribute to the literature and will have a significant impact on the quality of life of many cancer patients and cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Intervention Group Afterwards, patients taking paclitaxel-paclitaxel-herceptin will be given a nurse-led Motivational Interview about CIPN, physical activity and regular physical activity-walking. Patients will be instructed that the goal is to beat the previous number of steps each time. If he/she has problems/shortness of breath, chest pain, palpitation complaints during walking, he/she will be told to take a break from walking and rest. The study will be conducted under the supervision of a Medical Oncology specialist throughout the study, as well as the controls of patients with ongoing symptoms. Participants will be given a pedometer for regular follow-up, its use will be explained, and it will be told to mark it on the walking tracking chart. It will be emphasized that rhythmic walking is important for the pedometer to count correctly. Motivational Interview sessions will be conducted face-to-face at the beginning, week 4 and week 8. |
|
| control group | No Intervention | control group will receive standard practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| walking exercise | Behavioral | Intervention Group Afterwards, patients taking paclitaxel-paclitaxel-herceptin will be given a nurse-led Motivational Interview about CIPN, physical activity and regular physical activity-walking. Patients will be instructed that the goal is to beat the previous number of steps each time. If he/she has problems/shortness of breath, chest pain, palpitation complaints during walking, he/she will be told to take a break from walking and rest. The study will be conducted under the supervision of a Medical Oncology specialist throughout the study, as well as the controls of patients with ongoing symptoms. Participants will be given a pedometer for regular follow-up, its use will be explained, and it will be told to mark it on the walking tracking chart. It will be emphasized that rhythmic walking is important for the pedometer to count correctly. Motivational Interview sessions will be conducted face-to-face at the beginning, week 4 and week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) | The first section assesses the nine main symptoms as well as their severity, the extent to which they cause emotional disruption, and the frequency of their occurrence. The first six items in this section are related to sensory symptoms, while the seventh, eighth and ninth items are related to sub-dimensions of motor symptoms. In the second part, 14 activities were evaluated and questions were asked about the effect level of these substances. The activities assessed included fine motor and general activities. To assess the symptoms listed in the first section, "Yes" was considered equal to 1 point and "No" equal to 0 (0-9); their severity, symptoms, extent and frequency of emotional impairment were scored between 0 and 10 (0-270). The total score for the first part of the instrument is between 0 and 279. The effect level on the 14 activities in the second part was calculated between 0 and 10 (0-140). The Cronbach's alpha value of the original scale is 0.95 | 4 weeks after the first assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Selda Arslan, Phd | Necmettin Erbakan University Faculty of Nursing | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necmettin Erbakan University | Konya | 42060 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| D018771 | Arthralgia |
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Prospective randomized controlled clinical trial
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|
| D017437 |
| Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D059352 | Musculoskeletal Pain |