The Effect of Walking Exercise Based on TOUS on Peripheral Neuropathy and Arthralgia-Myalgia in Women With Breast Cancer

NCT05448209 | Completed DMC

• 1 other identifier: 198411013011
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Peripheral Neuropathies; Arthralgia; Myalgia

Keywords

Breast Cancer; Peripheral Neuropathies; Arthralgia; Myalgia; theory

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Behavioral: walking exercise

control group

NO INTERVENTION

control group will receive standard practice

Interventions

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over,
• Eastern Cooperative Oncology Group (ECOG) Status 0 to 1
• Receiving Paclitaxel or Paclitaxel-Herceptin
• Patients with 12 weeks defined in the protocol will be included.

You may not qualify if:

• Those with open wounds and edema on their hands and feet
• Patients with diabetes mellitus and peripheral neuropathy due to autoimmune disease
• Use other complementary therapies to prevent peripheral neuropathy throughout the treatment process.
• Conditions that limit exercise such as cardiovascular, pulmonary, musculoskeletal system
• Those with psychological and communication problems

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, 42060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases; Arthralgia; Myalgia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Pain

Study Officials

• Selda Arslan, Phd

  Necmettin Erbakan University Faculty of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: July 20, 2022
• Primary Completion: July 6, 2023
• Study Completion: October 6, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)