LevineConservationModelandColorectalPatients

NCT06499129 | Completed DMC

• 1 other identifier: Necmettin Erbakan University
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Anxiety; Peripheral Neuropathy

Keywords

Colorectal cancer, Levine's Conservation Nursing Model, Nursing intervention

Outcome Measures

Primary Outcomes (3)

• Cancer Fatigue Scale

  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

  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

  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

Study Arms (2)

SensoryBall

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Sensory ball, progressive relaxation exercise, training BEHAVIORAL

The effect of sensory ball use on fatigue, peripheral neuropathy and anxiety will be examined

SensoryBall

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of neuropathy or diabetes,
• History of hypothyroidism, renal failure,
• Hearing, speech and vision problems,
• Receiving radiotherapy or immunotherapy,
• Psychiatric diagnosis or ongoing treatment.

Sponsors & Collaborators

• Necmettin Erbakan University: collaborator
• KTO Karatay University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 22547012 RESULT

MeSH Terms

Conditions

Fatigue; Peripheral Nervous System Diseases; Anxiety Disorders; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Naciye Esra koyuncu

  NECMETTİN ERBAKAN ÜNİVERSİTESİ SB ENSTİTÜSÜ

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Assistant

Model Details: Randomized Controlled Trials

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 12, 2024
• Study Start: June 25, 2025
• Primary Completion: December 28, 2025
• Study Completion: December 28, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

TU (1)