LevineConservationModelandColorectalPatients

January 13, 2026 updated by: Naciye Esra Koyuncu, KTO Karatay University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Meram
      • Konya, Meram, Turkey (Türkiye)
        • Necmettin Erbakan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SensoryBall

The training content prepared based on the Levine Conservation Model will be given to patients assigned to the intervention group. Training content information in line with the Levine Conservation Model; The conservation model, which is the application of nursing theoretical knowledge for practice, will focus on the applications to be made for three basic principles for the protection of energy, protection of structural integrity and protection of personal integrity.

Soft plastic sensory balls for hands and feet will be used in the management of peripheral neuropathy symptom.

In the sensory exercise for the feet, the patient will be asked to place the foot sensory ball between the floor and the foot and roll it to create a slight pressure on the sole of the foot.

Progressive Relaxation Exercises Practice Progressive relaxation exercises will be played to colorectal cancer patients who will receive chemotherapy.
Behavioral: Sensory ball, progressive relaxation exercise, training
The effect of sensory ball use on fatigue, peripheral neuropathy and anxiety will be examined
No Intervention: Control
The control group patients who will receive chemotherapy treatment for the first time and who meet the inclusion criteria will not receive any intervention other than standard chemotherapy treatment and standard nursing care and will be asked to complete the Personal Information Form (only on the first day), Cancer Fatigue Scale, CIPNAT and Trait Anxiety Inventory on the first chemotherapy day, 14th day and 28th day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Fatigue Scale
Time Frame: 30 days
A five-point Likert scale (1-5) is used for each question. Cronbach's alpha value was 0.74. The scale consists of "physical" (7 items) (1,2,3,6,9,12,15), "cognitive" (4 items) (4,7,10,13), "emotional" (4 items) (5,8,11,14), 3 subheadings and 15 questions in total. In the analysis of the scale, physical state (item 1+2+3+6+9+12+15) is calculated by subtracting 7 from the total, emotional state (item 5+8+11+14) is calculated by adding, cognitive state (item 4+7+10+13) is calculated by subtracting 4 from the total. The total score is calculated by summing the physical, emotional and cognitive states. The minimum score is 4 and the maximum score is 64.
30 days
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool
Time Frame: 30 days
The first 6 questions in the scale are sensory symptoms and questions 7-9 are motor symptoms sub-dimensions. Experiencing the symptom of peripheral neuropathy (1=Yes, 2=No), the severity of the symptom (1=Never severe, 10= Extremely severe), the distress caused by the symptom (1= Never caused, 10= Extremely caused), the frequency of the symptom (1= Never experienced, 10= Continuously experienced), the activities of peripheral neuropathy symptoms (1= Never prevented, 10= Completely prevented). The first 9 items assess symptom presence (0-1), symptom severity (0-10), emotional distress (0-10) and frequency (0-10). The total score that can be obtained from the scale is between 0-279.
30 days
Trait Anxiety Inventory
Time Frame: 30 days
The reversed statements of the Trait Anxiety Inventory (SAI) consist of items 21, 26, 27, 30, 33, 36 and 39. A total score between 20 and 80 is obtained from the scale. After the total scores of the direct and inverted statements are found separately, the total score obtained for the direct statements is subtracted from the total score obtained for the inverted statements. A predetermined and unchanging value is added to this number. This value is 35 for the SDI. The last value obtained is the anxiety score of the individual. A low score means that the anxiety level of the individual is low and a high score means that the anxiety level of the individual is high.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KTO Karatay University

Collaborators

Necmettin Erbakan University

Investigators

  • Study Chair: Naciye Esra koyuncu, NECMETTİN ERBAKAN ÜNİVERSİTESİ SB ENSTİTÜSÜ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2025

Primary Completion (Actual)

December 28, 2025

Study Completion (Actual)

December 28, 2025

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Necmettin Erbakan University (Necmettin Erbakan University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fatigue

Clinical Trials on Sensory ball, progressive relaxation exercise, training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe