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

NCT ID: NCT06012253

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-12-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chemotherapeutic Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled trial consisting of two groups: experimental and control
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Single Blind (Participant, Outcomes Assessor)

Study Groups

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Home Based Walking Program

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

Group Type EXPERIMENTAL

Home Based Walking Program

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hava Kara

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma Arikan, PhD, RN

Role: STUDY_DIRECTOR

Akdeniz University

Locations

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Akdeniz University

Konyaalti, Antalya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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"70904504/376"

Identifier Type: -

Identifier Source: org_study_id

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