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

June 15, 2025 updated by: Hava Kara, Akdeniz University Hospital

The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life in Patients Receiving Taxane and Platinum-Based Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was designed as a randomized controlled trial. This study will be carried out with a total of 88 cancer patients receiving taxane and platinum-based chemotherapy, 44 of whom were in the intervention group and 44 in the control group, whose treatment was started in Akdeniz University Hospital."Home Based Walking Program" will be applied to the patients in the intervention group for 8 weeks.Within the scope of the Home-Based Walking Program, face-to-face patient education, patient education booklet, sending text messages, face-to-face and telephone counseling were planned.

Patient Identification Form, International Physical Activity Questionnaire (IPAQ- Short Form), National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria, Cancer Fatigue Scale, EORTC QLQ-CIPN20 (Quality of Life Chemotherapy-Induced Peripheral Neuropathy) and EORTC QLQ-C30 (Quality of Life Scale), Interview Form will be used to collect data.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Antalya
      • Konyaaltı, Antalya, Turkey, 07058
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

İnclusion Criteria

  • 18 Years and older (Adult, Older Adult )
  • Turkish speaking-understanding ability and literate.
  • Orientation (person, place, time)
  • Receiving taxane and platinum-based chemotherapy treatment (monotherapy or combined).
  • Receiving chemotherapy treatment for the first time.
  • The primary medical diagnosis is cancer (breast cancer, colorectal cancers and other cancers).
  • Not having health problems that prevent walking.
  • Agreeing to participate in the research.

Exclusion Criteria

  • 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"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home Based Walking Program
Effect of home-based walking program on peripheral neuropathy, fatigue and quality of life
Other: Home Based Walking Program
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.
No Intervention: Control group
The control group will be given the "Ministry of Health Physical Activity Guidelines".Routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Questionnaire (IPAQ- Short Form)
Time Frame: Baseline and 8th week
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
Time Frame: Baseline and 8th week
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
Time Frame: Baseline and 8th week
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)
Time Frame: Baseline and 8th week
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)
Time Frame: Baseline and 8th week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University Hospital

Investigators

  • Study Director: Fatma Arikan, PhD, RN, Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

December 20, 2024

Study Registration Dates

First Submitted

August 19, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 15, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • "70904504/376"

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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