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Trial Title:
LevineConservationModelandColorectalPatients
NCT ID:
NCT06499129
Condition:
Fatigue
Peripheral Neuropathy
Anxiety
Conditions: Official terms:
Peripheral Nervous System Diseases
Fatigue
Conditions: Keywords:
Colorectal cancer, Levine's Conservation Nursing Model, Nursing intervention
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized Controlled Trials
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Sensory ball, progressive relaxation exercise, training
Description:
The effect of sensory ball use on fatigue, peripheral neuropathy and anxiety will be
examined
Arm group label:
SensoryBall
Summary:
Colorectal cancer is one of the most common types of cancer in the world, ranking 3rd
among cancers that cause death in men and women. In patients diagnosed with colorectal
cancer, chemotherapy treatment is planned to prolong survival as in all other cancer
patients. Among the side effects of chemotherapy treatment, it is known that fatigue
develops between 50-90%, which is mild for one week in 45% of patients and persists for
two weeks in 33%. In the literature, the incidence of chemotherapy-induced peripheral
neuropathy is reported to be between 10-100% depending on the type and dose of the drug
taken. Alejandro et al. (2013) reported that the incidence of oxaliplatin-related
peripheral neuropathy was 84%, which was acute in 74% of patients and permanent in 48%.
In addition, anxiety disorders are among the common mental symptoms in cancer patients
and their prevalence has been reported to be 10-30%.
In this study, it is aimed to reveal the effect of nursing interventions based on
Levine's Conservation Model on fatigue, peripheral neuropathy and anxiety levels in
colorectal cancer patients receiving chemotherapy treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Between the ages of 18-75
- Diagnosed with primary and new colorectal cancer (Stage II and III),
- The decision to start the FOLFOX treatment protocol has been taken,
- Having a smartphone,
- Being literate,
- Ability to speak and understand Turkish,
- Open to communication and cooperation.
Exclusion Criteria:
- History of neuropathy or diabetes,
- History of hypothyroidism, renal failure,
- Hearing, speech and vision problems,
- Receiving radiotherapy or immunotherapy,
- Psychiatric diagnosis or ongoing treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 15, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
KTO Karatay University
Agency class:
Other
Collaborator:
Agency:
Necmettin Erbakan University
Agency class:
Other
Source:
KTO Karatay University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06499129
