The Effect of Walking and Grounding in Women With Breast Cancer

NCT06767059 | Recruiting

• 1 other identifier: AÜ-HEM-BB-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial was conducted to examine the effect of walking and grounding on pain intensity, fatigue level and sleep quality in women diagnosed with breast cancer.

Conditions

Breast Cancer

Keywords

Breast cancer; Walking; Grounding; Nursing

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  It will be used in the study to measure pain, fatigue, and sleep severity. The VAS consists of a measured horizontal or vertical line with definitions such as "no symptoms" or "severe symptoms" at both ends. The severity of the patient's symptoms is measured by marking a numbered point on this line. For pain symptoms, the severity is marked on a 10 cm (100 mm) ruler with "no pain" at one end and "unbearable pain" at the other. The intervals for pain severity are defined as follows: \<3 mild pain, 3-6 moderate pain, \>6 severe pain. The VAS is a reliable and valid method for assessing pain intensity (Arslan et al., 2016). The VAS will also be used to assess fatigue and sleep intensity. It is marked as 0 none to 10 very much. It is measured as 0 none, 1-3 mild, 4-6 moderate, and 7-9 severe.

  0,4,8 weeks

Secondary Outcomes (2)

• Visual Similarity Scale for Fatigue

  0,4,8 weeks

• Pittssburgh Sleep Quality Index

  0,4,8 weeks

Study Arms (3)

Walking Group

EXPERIMENTAL

Patients will walk for 30 minutes at least 3 times a week.

Other: Walking Group

Grounding Group

EXPERIMENTAL

Patients will walk with a grounding stick for 30 minutes at least 3 times a week.

Other: Grounding Group

Control Group

NO INTERVENTION

Routine follow-up will be done.

Interventions

Walking Group OTHER

Patients will be asked to walk for 30 minutes at least 3 times for 8 weeks. In order to ensure regular follow-up, patients will be asked to write on the walking tracking form when they walk and the number of steps before they start walking and the number of steps after walking using the application.

Walking Group

Grounding Group OTHER

Patients will be asked to walk with a grounding stick for 30 minutes at least 3 times for 8 weeks. Patients will be asked to fill in the walking follow-up form and grounding follow-up form for regular follow-up.

Grounding Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast cancer is diagnosed more frequently in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older,
• Can read and write and speak Turkish,
• Diagnosed with primary breast cancer and know the diagnosis,
• Volunteered to participate in the research,
• Living in Ankara province,
• Paclitaxel or Paclitaxel-Transtuzumab based chemotherapy treatment initiated,
• Eastern Cooperative Oncology Group (ECOG) Scale 0 or 1,
• NCI-CTCAE v5.0 Pain, fatigue and sleep toxicity grade 1 or 2,
• You have a phone with an iOS or Android processor,

You may not qualify if:

• Open wounds or edema of the hands and feet,
• NCI-CTCAE v5.0 motor and sensory peripheral neuropathy with toxicity grade 3,4 or 5,
• People with a disability that would prevent them from walking,
• Diagnosed cardiovascular and pulmonary disorders,
• Diagnosed psychiatric illness,
• Communication problems,
• Bone metastases,
• Bilateral mastectomies,

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Gazi University Health Research and Application Center Gazi Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Baise Bicav, MSc

  Ankara University

  PRINCIPAL INVESTIGATOR

• Sevinç Kutlutürkan, PhD

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baise Bicav

CONTACT

05454702157; baisebicav@gmail.com

Sevinç Kutlutürkan

CONTACT

03122126040; skutluturkan@ankara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be told which group they are in the study. To prevent selection bias in the study, the determination of the groups will be made by the nurse outside the study. To prevent omission and reporting bias in the study, the data will be coded with the letters A, B and C without specifying which group they are in. The data will be computerized by a person outside the study. Data will be analyzed coded in terms of groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Science Specialist Lecturer

Model Details: Three groups with walking, grounding and control group

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: January 30, 2025
• Primary Completion: January 15, 2026
• Study Completion: March 15, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)