The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life in Patients Receiving Taxane and Platinum-Based Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN 20)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Single Blind (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •xclusion 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"
Arms & Interventions
Home Based Walking Program
Effect of home-based walking program on peripheral neuropathy, fatigue and quality of life
Intervention: Home Based Walking Program (Other)
Control group
The control group will be given the "Ministry of Health Physical Activity Guidelines".Routine care.
Outcomes
Primary Outcomes
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN 20)
Time Frame: 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.
International Physical Activity Questionnaire (IPAQ- Short Form)
Time Frame: 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
Time Frame: 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
Time Frame: 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 (EORTC QLQ-C30)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hava Kara
Principal Investigator
Akdeniz University