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

Primary Purpose

Chemotherapeutic Toxicity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home Based Walking Program
Sponsored by
Akdeniz University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapeutic Toxicity focused on measuring Home-based walking program, Chemotherapy, Cancer, Peripheral neuropathy, Fatigue, Quality of life, Nurse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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"

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Home Based Walking Program

    Control group

    Arm Description

    Effect of home-based walking program on peripheral neuropathy, fatigue and quality of life

    The control group will be given the "Ministry of Health Physical Activity Guidelines".Routine care.

    Outcomes

    Primary Outcome Measures

    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).
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2023
    Last Updated
    August 28, 2023
    Sponsor
    Akdeniz University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06012253
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2024 (Anticipated)
    Study Completion Date
    September 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Akdeniz University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapeutic Toxicity
    Keywords
    Home-based walking program, Chemotherapy, Cancer, Peripheral neuropathy, Fatigue, Quality of life, Nurse

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a randomized controlled trial consisting of two groups: experimental and control
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Single Blind (Participant, Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Home Based Walking Program
    Arm Type
    Experimental
    Arm Description
    Effect of home-based walking program on peripheral neuropathy, fatigue and quality of life
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The control group will be given the "Ministry of Health Physical Activity Guidelines".Routine care.
    Intervention Type
    Other
    Intervention Name(s)
    Home Based Walking Program
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    International Physical Activity Questionnaire (IPAQ- Short Form)
    Description
    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).
    Time Frame
    Baseline and 8th week
    Title
    National Cancer Institute (NCI) -CTCAE v5.0 Toxicity Criteria
    Description
    This scale was developed to evaluate the grading of chemotherapy-related peripheral neurotoxicity. It evaluates sensory and motor neuropathy between grades 1-5.
    Time Frame
    Baseline and 8th week
    Title
    Cancer Fatigue Scale
    Description
    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.
    Time Frame
    Baseline and 8th week
    Title
    European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN 20)
    Description
    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.
    Time Frame
    Baseline and 8th week
    Title
    European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
    Description
    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.
    Time Frame
    Baseline and 8th week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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"
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hava Kara
    Phone
    +905547267943
    Email
    bilgin008@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fatma Arikan, PhD, RN
    Organizational Affiliation
    Akdeniz University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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