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

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

NCT ID: NCT06012253

Condition: Chemotherapeutic Toxicity

Conditions: Official terms:
Peripheral Nervous System Diseases
Fatigue

Conditions: Keywords:
Home-based walking program
Chemotherapy
Cancer
Peripheral neuropathy
Fatigue
Quality of life
Nurse

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: This is a randomized controlled trial consisting of two groups: experimental and control

Primary purpose: Supportive Care

Masking: Double (Participant, Outcomes Assessor)

Masking description: Single Blind (Participant, Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: Home Based Walking Program
Description: 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.
Arm group label: Home Based Walking Program

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.

Detailed description: The study was designed as a randomized controlled trial. This study will be carried out with a total of 86 cancer patients receiving taxane and platinum-based chemotherapy, 43 of whom were in the intervention group and 43 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.

Criteria for eligibility:
Criteria:
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"

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Akdeniz University

Address:
City: Konyaaltı
Zip: 07058
Country: Turkey

Status: Recruiting

Contact:
Last name: Hava Kara, MSc
Email: bilgin008@hotmail.com

Start date: September 15, 2023

Completion date: September 30, 2024

Lead sponsor:
Agency: Akdeniz University Hospital
Agency class: Other

Source: Akdeniz University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06012253