CancerNCT06744803
The Effect of a Gamified Neuropathy Management Application on Cancer Behavior in Cancer Patients Undergoing Chemotherapy
A study testing Gamified Neuropathy Management Application on Cancer Behavior in people with Cancer and Chemotherapy Induced Pain Neuropathy, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to determine the effect of a gamified neuropathy management application on cancer behavior in cancer patients undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer, Chemotherapy Induced Pain Neuropathy, Nursing
- What is being tested?
- Gamified Neuropathy Management Application on Cancer Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing chemotherapy treatment and have completed their first cycle.
- Literate (able to read and write).
- Able to use a smartphone.
- Aged between 18 and 65 years.
- Willing to participate in the study voluntarily.
Who cannot join
- Participants who do not use the application during the study period
- Participants who fail to complete the data collection forms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazit University
Ankara, 06000
About this study
Official title: The Effect of a Gamified Neuropathy Management Application on Cancer Behavior in Cancer Patients Undergoing Chemotherapy: A Prospective Follow-Up Study
This study will be conducted to determine the effect of a gamified neuropathy management application on cancer behavior in cancer patients undergoing chemotherapy.
Read the detailed description
Cancer patients may experience treatment-related issues throughout their treatment process. Chemotherapy-induced peripheral neuropathy is one of the symptoms that negatively affects patients' overall health status. Peripheral neuropathy can occur during or after chemotherapy, leading to sensory, motor, and autonomic nerve damage. It is particularly common among cancer patients receiving taxane- and platinum-based chemotherapy.
Effective management of neuropathy is a crucial aspect of nursing care. Here are some key points regarding this issue: pharmacological and non-pharmacological methods, lifestyle control, and nursing interventions are employed. The management of peripheral neuropathy can have a significant impact on the overall health and well-being of cancer patients undergoing chemotherapy. Nurses play a vital role in this process by providing support that enhances patients' quality of life and improves treatment outcomes.
Gamification applications, which have recently started to be used in patient education, represent a contemporary approach. However, no studies have been found utilizing gamification specifically in patient education for cancer. For this reason, this study aims to contribute to patients' neuropathy management using a gamification application.
- Conditions
- Cancer, Chemotherapy Induced Pain Neuropathy, Nursing, Gamification
- Being tested
- Gamified Neuropathy Management Application on Cancer Behavior
- Keywords
- cancer, chemotherapy induced pain neuropathy, nursing, gamification
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Neuropathy Management Application on Cancer BehaviorBehavioural
Also called intervention group
The study will be conducted in three phases:
Phase 1: The content of the gamified neuropathy management application used in the study will be prepared by the researchers using relevant literature.
Phase 2: The developed gamified neuropathy management application will be introduced to patients during one-on-one interviews at the daytime chemotherapy clinic. After collecting pre-test data, the application will be sent to the patients, who will be asked to use it for 8 weeks.
Phase 3: Following the start of the study's implementation, patients will be contacted in the 4th and 8th weeks to collect mid-study and post-test data.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Gamified Neuropathy Management Application Receives: Behavioral: Gamified Neuropathy Management Application on Cancer Behavior |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of gamified neuropathy management application on chemotherapy-associated peripheral neuropathic pain.
DN4 Questionnaire: The DN4 pain questionnaire, developed by the French neuropathic pain group, is a questionnaire that includes symptoms and findings associated with neuropathic pain. The individual being evaluated answers the questions with yes or no. The total scale score is calculated by giving 1 point for each yes answer and 0 point for each no answer. In the scale, the cutoff value for neuropathic pain is determined as 4/10 and above. Turkish validity and reliability was determined by Unal-Çevik et al. It was made by and the Cronbach alpha coefficient was 0.97; The specificity and sensitivity in diagnosing neuropathic pain were found to be 96.6% and 95%, respectively.
Measured: 6 months
The effect of gamified neuropathy management application on chemotherapy-associated peripheral neuropathic level
CIPNAT, Tofthagen et al. (2011b). CIPNAT, which is a Likert type scale, consists of 2 parts. The first part consists of 36 items asking about symptom frequency, severity, and discomfort. In the second part, there are 14 items that evaluate which of the daily living activities peripheral neuropathy affects. First, patients are asked whether any of the nine symptoms developed after chemotherapy treatment. The frequency, severity and discomfort of the symptoms experienced after each question answered "Yes" are scored and evaluated with a 0-10 numerical rating scale. If the answer to the first 4 questions on the scale is "No", the other questions are not continued. These questions are the questions that determine whether there is the presence of CBPN (Kutlutürkan et al. 2017). A high score from the scale indicates that CBPN is high. The Turkish validity and reliability study of the scale was conducted by Kutlutürkan et al. (2017). The Cronbach alpha coefficient of the scale is 0.970.
Measured: 6 months
The effect of gamified neuropathy management application on cancer behaviour
Heitzmann et al. Developed by KSI-KV in 2011. This inventory is a 12-item unidimensional measurement tool designed to assess cancer patients' self-efficacy in coping. Each item of this 12-item scale is scored between 1-9. The scale score is calculated as the sum of all items. High scores from the scale indicate high self-efficacy for coping. The Cronbach alpha coefficient of this scale, which was evaluated on three sample groups, was found to be a = 0.84, a = 0.84, a = 0.88 for each sample, respectively. The construct validity of the scale was conducted using Exploratory Factor Analysis for the first sample, and four factors were obtained according to the results of the analysis: (1) Maintaining Independence and Positive Attitude; (2) Participating in Medical Care; (3) Coping and Stress Management; (4) Managing Affect. Adaptation of this scale to Turkish was made by İyigün et al. (2017).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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 control trial (prospective follow up study)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Çakmak, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744803
- Sponsor's protocol ID
- 01.08.2024/78 KARAR NO:36
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I have not discussed this with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Gamified Neuropathy Management Application on Cancer Behavior in Cancer Patients Undergoing Chemotherapy: A Prospective Follow-Up Study
- ClinicalTrials.gov ID
- NCT06744803
- Acronym / sponsor ID
- 01.08.2024/78 KARAR NO:36
- Conditions
- Cancer, Chemotherapy Induced Pain Neuropathy, Nursing, Gamification
- Keywords
- cancer, chemotherapy induced pain neuropathy, nursing, gamification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Dec 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.
This study will be conducted to determine the effect of a gamified neuropathy management application on cancer behavior in cancer patients undergoing chemotherapy.
Detailed description
Cancer patients may experience treatment-related issues throughout their treatment process. Chemotherapy-induced peripheral neuropathy is one of the symptoms that negatively affects patients' overall health status. Peripheral neuropathy can occur during or after chemotherapy, leading to sensory, motor, and autonomic nerve damage. It is particularly common among cancer patients receiving taxane- and platinum-based chemotherapy.
Effective management of neuropathy is a crucial aspect of nursing care. Here are some key points regarding this issue: pharmacological and non-pharmacological methods, lifestyle control, and nursing interventions are employed. The management of peripheral neuropathy can have a significant impact on the overall health and well-being of cancer patients undergoing chemotherapy. Nurses play a vital role in this process by providing support that enhances patients' quality of life and improves treatment outcomes.
Gamification applications, which have recently started to be used in patient education, represent a contemporary approach. However, no studies have been found utilizing gamification specifically in patient education for cancer. For this reason, this study aims to contribute to patients' neuropathy management using a gamification application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial (prospective follow up study)
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Gamified Neuropathy Management Application on Cancer BehaviorGamified Neuropathy Management Application |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing chemotherapy treatment and have completed their first cycle.
- Literate (able to read and write).
- Able to use a smartphone.
- Aged between 18 and 65 years.
- Willing to participate in the study voluntarily.
Key exclusion criteria (2 listed)
- Participants who do not use the application during the study period
- Participants who fail to complete the data collection forms
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 |
|---|---|---|
| Gamified Neuropathy Management Application on Cancer BehaviorAlso: intervention groupThe study will be conducted in three phases: Phase 1: The content of the gamified neuropathy management application used in the study will be prepared by the researchers using relevant literature. Phase 2: The developed gamified neuropathy management application will be introduced to patients during one-on-one interviews at the daytime chemotherapy clinic. After collecting pre-test data, the application will be sent to the patients, who will be asked to use it for 8 weeks. Phase 3: Following the start of the study's implementation, patients will be contacted in the 4th and 8th weeks to collect mid-study and post-test data. | Behavioural | intervention group |
Primary outcome
The effect of gamified neuropathy management application on chemotherapy-associated peripheral neuropathic pain.
Time frame: 6 months
DN4 Questionnaire: The DN4 pain questionnaire, developed by the French neuropathic pain group, is a questionnaire that includes symptoms and findings associated with neuropathic pain. The individual being evaluated answers the questions with yes or no. The total scale score is calculated by giving 1 point for each yes answer and 0 point for each no answer. In the scale, the cutoff value for neuropathic pain is determined as 4/10 and above. Turkish validity and reliability was determined by Unal-Çevik et al. It was made by and the Cronbach alpha coefficient was 0.97; The specificity and sensitivity in diagnosing neuropathic pain were found to be 96.6% and 95%, respectively.
The effect of gamified neuropathy management application on chemotherapy-associated peripheral neuropathic level
Time frame: 6 months
CIPNAT, Tofthagen et al. (2011b). CIPNAT, which is a Likert type scale, consists of 2 parts. The first part consists of 36 items asking about symptom frequency, severity, and discomfort. In the second part, there are 14 items that evaluate which of the daily living activities peripheral neuropathy affects. First, patients are asked whether any of the nine symptoms developed after chemotherapy treatment. The frequency, severity and discomfort of the symptoms experienced after each question answered "Yes" are scored and evaluated with a 0-10 numerical rating scale. If the answer to the first 4 questions on the scale is "No", the other questions are not continued. These questions are the questions that determine whether there is the presence of CBPN (Kutlutürkan et al. 2017). A high score from the scale indicates that CBPN is high. The Turkish validity and reliability study of the scale was conducted by Kutlutürkan et al. (2017). The Cronbach alpha coefficient of the scale is 0.970.
The effect of gamified neuropathy management application on cancer behaviour
Time frame: 6 months
Heitzmann et al. Developed by KSI-KV in 2011. This inventory is a 12-item unidimensional measurement tool designed to assess cancer patients' self-efficacy in coping. Each item of this 12-item scale is scored between 1-9. The scale score is calculated as the sum of all items. High scores from the scale indicate high self-efficacy for coping. The Cronbach alpha coefficient of this scale, which was evaluated on three sample groups, was found to be a = 0.84, a = 0.84, a = 0.88 for each sample, respectively. The construct validity of the scale was conducted using Exploratory Factor Analysis for the first sample, and four factors were obtained according to the results of the analysis: (1) Maintaining Independence and Positive Attitude; (2) Participating in Medical Care; (3) Coping and Stress Management; (4) Managing Affect. Adaptation of this scale to Turkish was made by İyigün et al. (2017).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Undecided. I have not discussed this with other researchers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Neuropathy Management Application on Cancer Behavior in people with Cancer and Chemotherapy Induced Pain Neuropathy, run by Ankara Yildirim Beyazıt 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 20 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BETÜL ÇAKMAK, RN,PHD (0534-082-92-87, b.cakmak@aybu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of gamified neuropathy management application on chemotherapy-associated peripheral neuropathic pain. (time frame: 6 months). 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?
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 20 Dec 2024.