Clinical trial NCT06012253: The Effect of Home-Based Walking Program on Peripheral Neuropathy, Fatigue and Quality of Life
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapeutic Toxicity
Keywords: Home-based walking program
Chemotherapy
Cancer
Peripheral neuropathy
Fatigue
Quality of life
Nurse
Lead sponsor: Akdeniz University Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial consisting of two groups: experimental and control
Primary purpose: SUPPORTIVE_CARE

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.

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"

Primary outcomes:
measure: International Physical Activity Questionnaire (IPAQ- Short Form)
timeFrame: Baseline and 8th week
measure: National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria
timeFrame: Baseline and 8th week
measure: Cancer Fatigue Scale
timeFrame: Baseline and 8th week
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN 20)
timeFrame: Baseline and 8th week
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline and 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Konyaaltı
country: Turkey
facility: Akdeniz University
state: Antalya
Study officials:
affiliation: Akdeniz University
name: Fatma Arikan, PhD, RN
role: STUDY_DIRECTOR
References: