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

Sponsor

Akdeniz University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06012253

Collaborator

(none)

Enrollment

Arms

12.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapeutic Toxicity	Other: Home Based Walking Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a randomized controlled trial consisting of two groups: experimental and controlThis is a randomized controlled trial consisting of two groups: experimental and control

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Single Blind (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

International Physical Activity Questionnaire (IPAQ- Short Form) [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).
National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria [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.
Cancer Fatigue Scale [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.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN 20) [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.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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"