The Effect of Walking Exercise Based on TOUS on Peripheral Neuropathy and Arthralgia-Myalgia in Women With Breast Cancer
Condition: Breast Cancer; Peripheral Neuropathies; Arthralgia; Myalgia
MeSH terms: Breast Neoplasms; Arthralgia; Myalgia; Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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

        -  At the stage of implementation, patients receiving Paclitaxel-Paclitaxel-Herceptin
           chemotherapy protocol sent by the City Hospital Medical Oncology Specialist will be
           interviewed and the purpose of the research will be explained and written/verbal consent
           will be obtained. Consent will be taken in the Oncology Training Nurse room. Patients
           who accept the study will be evaluated in terms of inclusion and exclusion criteria.

        -  Personal information form, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool,
           McGill Melzack Pain Questionnaire, Modified BORG Scale, ECOG Performance Scale will be
           evaluated by interview method at the beginning of the patients who accept the study.

        -  Afterwards, a nurse-led Motivational Interview will be held about CIPN, physical
           activity and regular physical activity-walking for patients taking
           paclitaxel-paclitaxel-herceptin. Patients will be informed about the study and their
           written consent will be obtained.

        -  They will be told to walk at a moderate intensity, usually defined as the BORG Scale of
           4 to 5 perceived effort, three to five days a week to start with 10 minutes initially,
           then continue until they reach 30 or 60 minutes, 3 times a week. Patients will be
           instructed that the goal is to exceed the previous number of steps each time.

        -  Participants will be informed that if they feel fatigue, lethargy, balance problems,
           pain, palpitations throughout the day, they can do their exercise the next day.

        -  If he/she has trouble/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 they will be told to mark it on the walking tracking chart. How to register will be
           explained. The initial step count will be recorded as the number of steps recorded on
           the first day the patient used the pedometer.

        -  It will be emphasized that rhythmic walking is important for the pedometer to count
           correctly.

        -  What Is Your Biggest Physical Activity Barrier? Do you forget to be physically active?
           For example, if a participant's biggest obstacle is forgetting to walk, the expression
           of intent might be: "If it's six o'clock on Saturday, then I'll walk for 10 minutes." If
           then the application notification form.

        -  Motivational Interview sessions will be conducted face-to-face at the beginning, week 4
           and week 8.

        -  Intervention participants will be added to a Watsap group and invited to weekly group
           walk events with other intervention group participants.

        -  They will receive a weekly written motivational message and will be encouraged to join
           the WhatsApp discussion.

      Control Group

        -  Patients in the control group will receive routine training given by Oncology Education
           Nursing.

        -  Personal information form, Chemotherapy-Induced Peripheral Neuropathy Assessment Tool
           (CIPNAT), McGill Melzack Pain Questionnaire, Modified BORG Scale, ECOG Performance in
           the intervention and control group by a specialist nurse at week 0, week 4, week 8, and
           week 12 The scale will be evaluated.

        -  Continuously recorded step numbers in the Intervention and Control group 0.4.8. and will
           be evaluated for analysis, taking into account the last measurements of the 12th week.

        -  A special exercise prescription, namely MG-Walking intervention support, will not be
           provided to control group participants. Telephone follow-up (to assess adverse events)
           will take place. After the completion of the training, a supervised walking exercise
           will be offered to the participants if they wish.

      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.
    

Intervention name(s): walking exercise
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized controlled clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Breast Cancer; Peripheral Neuropathies; Arthralgia; Myalgia; theory