FatigueNCT06499129
LevineConservationModelandColorectalPatients
A study testing Sensory ball, progressive relaxation exercise, training in people with Fatigue and Peripheral Neuropathy, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fatigue, Peripheral Neuropathy, Anxiety
- What is being tested?
- Sensory ball, progressive relaxation exercise, training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2025to 28 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of neuropathy or diabetes,
- History of hypothyroidism, renal failure,
- Hearing, speech and vision problems,
- Receiving radiotherapy or immunotherapy,
- Psychiatric diagnosis or ongoing treatment.
Trial locations and contacts
1 site in 1 country.
About this study
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
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, Peripheral Neuropathy, Anxiety
- Being tested
- Sensory ball, progressive relaxation exercise, training
- Keywords
- Colorectal cancer, Levine's Conservation Nursing Model, Nursing intervention
- Medical subject headings
- Fatigue, Peripheral Nervous System Diseases, Anxiety Disorders, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory ball, progressive relaxation exercise, trainingBehavioural
The effect of sensory ball use on fatigue, peripheral neuropathy and anxiety will be examined
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start25 Jun 2025
- Primary completion28 Dec 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trials
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Collaborators
- Necmettin Erbakan University
- Responsible party
- Principal investigator, Naciye Esra Koyuncu, KTO Karatay University
- Investigators
- Naciye Esra koyuncu, Study chair, NECMETTİN ERBAKAN ÜNİVERSİTESİ SB ENSTİTÜSÜ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499129
- Sponsor's protocol ID
- Necmettin Erbakan University
- Status last verified
- Jan 2026
- First submitted
- 1 Jul 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22547012
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06499129
- Acronym / sponsor ID
- Necmettin Erbakan University
- Conditions
- Fatigue, Peripheral Neuropathy, Anxiety
- Keywords
- Colorectal cancer, Levine's Conservation Nursing Model, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Collaborators
- Necmettin Erbakan University
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 28 Dec 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trials
| Arm | Type | Receives |
|---|---|---|
| SensoryBall | Experimental | Behavioral: Sensory ball, progressive relaxation exercise, trainingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- History of neuropathy or diabetes,
- History of hypothyroidism, renal failure,
- Hearing, speech and vision problems,
- Receiving radiotherapy or immunotherapy,
- Psychiatric diagnosis or ongoing treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory ball, progressive relaxation exercise, trainingThe effect of sensory ball use on fatigue, peripheral neuropathy and anxiety will be examined | Behavioural | SensoryBall |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Results publication: PubMed 22547012Alejandro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naciye Esra koyuncu study chair
NECMETTİN ERBAKAN ÜNİVERSİTESİ SB ENSTİTÜSÜ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory ball, progressive relaxation exercise, training in people with Fatigue and Peripheral Neuropathy, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Fatigue Scale (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06499129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.