Clinical trial NCT06499129: LevineConservationModelandColorectalPatients
Official title: The Effect of Nursing Interventions Based on Levine Conservation Model on Fatigue, Peripheral Neuropathy and Anxiety Levels in Colorectal Cancer Patients Receiving Chemotherapy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fatigue
Peripheral Neuropathy
Anxiety
Keywords: Colorectal cancer, Levine's Conservation Nursing Model, Nursing intervention
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
Collaborators: name: Necmettin Erbakan University
First posted: 2024-07-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trials
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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.

Primary outcomes:
measure: Cancer Fatigue Scale
timeFrame: 30 days
measure: Chemotherapy-Induced Peripheral Neuropathy Assessment Tool
timeFrame: 30 days
measure: Trait Anxiety Inventory
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NECMETTİN ERBAKAN ÜNİVERSİTESİ SB ENSTİTÜSÜ
name: Naciye Esra koyuncu
role: STUDY_CHAIR
References:
citation: Alejandro LM, Behrendt CE, Chen K, Openshaw H, Shibata S. Predicting acute and persistent neuropathy associated with oxaliplatin. Am J Clin Oncol. 2013 Aug;36(4):331-7. doi: 10.1097/COC.0b013e318246b50d.