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

Chemotherapeutic Toxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012253
• Other study ID #: "70904504/376"
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Akdeniz University Hospital
• Contact: Hava Kara
• Phone: +905547267943
• Email: bilgin008[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Chemotherapeutic Toxicity
• Fatigue
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Konyaalti	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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