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NCT Number: NCT06499129

LevineConservationModelandColorectalPatients

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.

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Key information

Conditions

Fatigue Anxiety Anxiety Disorders Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peripheral Neuropathy Rectal Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensory ball, progressive relaxation exercise, training

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Collaborators

  • Necmettin Erbakan University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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