The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life

NCT06012253 | Completed

• 1 other identifier: "70904504/376"
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effect of home-based walking program on peripheral neuropathy, fatigue and quality of life in patients receiving taxane and platinum-based chemotherapy.

Conditions

Chemotherapeutic Toxicity

Keywords

Home-based walking program; Chemotherapy; Cancer; Peripheral neuropathy; Fatigue; Quality of life; Nurse

Outcome Measures

Primary Outcomes (5)

• International Physical Activity Questionnaire (IPAQ- Short Form)

  It is used to evaluate physical activity. The form includes walking, moderate and vigorous activity, sitting categories. The total score includes the sum of time (minutes) and frequency (days).

  Baseline and 8th week

• National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria

  This scale was developed to evaluate the grading of chemotherapy-related peripheral neurotoxicity. It evaluates sensory and motor neuropathy between grades 1-5.

  Baseline and 8th week

• Cancer Fatigue Scale

  This scale was developed to evaluate the fatigue of cancer patients. It includes 15 questions and three sub-dimensions: Physical, Affective and Cognitive. The Likert type form is evaluated by giving points. Increasing scores received from the scale demonstrate a high level of fatigue.

  Baseline and 8th week

• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN 20)

  This scale was developed to evaluate the effect of peripheral neuropathy on quality of life of cancer patients. It includes 20 questions and three sub-dimensions: Sensory, Motor and Autonomic. The Likert type form is evaluated by giving points. Increasing scores received from the scale demonstrate a high level of symptoms and problems related to peripheral neuropathy.

  Baseline and 8th week

• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: Global health status, Functional, Symptom. High scores in the functional subscale indicate good/healthy functional status, high scores in the symptom subscale indicate high levels of symptoms and/or problems, and high scores in the global health status/quality of life subscale indicate good quality of life.

  Baseline and 8th week

Study Arms (2)

Home Based Walking Program

EXPERIMENTAL

Effect of home-based walking program on peripheral neuropathy, fatigue and quality of life

Other: Home Based Walking Program

Control group

NO INTERVENTION

The control group will be given the "Ministry of Health Physical Activity Guidelines".Routine care.

Interventions

Home Based Walking Program OTHER

The intervention group will be applied to "Home Based Walking Program". It was aimed that the patients should do at least 150 minutes of moderate-intensity physical exercise per week for up to 8 weeks. The content of the program includes a walking information booklet (information notes, activity chart and obstacle avoidance form), exercise diary, face-to-face-telephone counseling, sending text messages, prepared in line with international guides. It was planned to give weekly counseling to the patients included in the intervention group for an 8-week period.

Home Based Walking Program

Eligibility Criteria

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

You may not qualify if:

• Being bone and brain metastases
• Being peripheral neuropathy due to reasons other than chemotherapy (such as chronic disease, diabetes mellitus, nutritional disorders)
• Skin sensitivity on the hands and feet
• Having cardiovascular, pulmonary, musculoskeletal, or psychological disorders that limit exercise or mobility
• Being in another supportive program
• Being in the very active category according to the "International Physical Activity Scale (IPAQ- Short Form)"
• Being a severity of more than 4 points according to the "Modified Borg Scale (MBS)"
• Being a score of 2 and above according to the "ECOG Performance Scale"

Sponsors & Collaborators

• Akdeniz University Hospital: lead

Study Sites (1)

Akdeniz University

Konyaalti, Antalya, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Peripheral Nervous System Diseases; Fatigue

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatma Arikan, PhD, RN

  Akdeniz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single Blind (Participant, Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized controlled trial consisting of two groups: experimental and control

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 25, 2023
• Study Start: September 15, 2023
• Primary Completion: August 30, 2024
• Study Completion: December 20, 2024
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)