CancerNCT07809386
The Effect of Gamified Sleep Hygiene Education on Sleep Quality and Fatigue Levels in Chemotherapy Patients
A study testing Gamified Sleep Hygiene Education and Standard Sleep Hygiene Education in people with Cancer, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
Sleep disturbances and fatigue are common problems among patients receiving chemotherapy and may negatively affect their quality of life. This randomized controlled trial aims to evaluate the effect of gamified sleep hygiene education on sleep quality and cancer-related fatigue in patients receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Gamified Sleep Hygiene Education and Standard Sleep Hygiene Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 30 Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Currently receiving chemotherapy
- Able to read and write in Turkish
- Able to communicate effectively
- Able to use a smartphone or tablet and access the web-based educational intervention
- No previous diagnosis of a sleep disorder
- No previous treatment for a sleep disorder
- Voluntary participation in the study
Who cannot join
- Presence of a major mental disorder that may interfere with participation in the study
- Presence of a major visual, hearing, or communication impairment that may interfere with participation in the study
- Unable to read or write in Turkish
- Unable to use a smartphone or tablet or access the web-based educational intervention
- Previous diagnosis of a sleep disorder
- Previous treatment for a sleep disorder
- Unwilling to participate in the study
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
Lokman Hekim University Ankara Hospital
Ankara
About this study
Sleep disturbances and fatigue are common problems among patients receiving chemotherapy and may negatively affect their quality of life. This randomized controlled trial aims to evaluate the effect of gamified sleep hygiene education on sleep quality and cancer-related fatigue in patients receiving chemotherapy.
A total of 56 patients will be randomly assigned to two groups, with 28 participants in each group. The intervention group will receive gamified sleep hygiene education through the web-based "Sleep Hunter" program, while the active comparator group will receive standard sleep hygiene education through verbal instruction and educational brochures. The intervention will be delivered in two sessions over a two-week period.
Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire, and cancer-related fatigue will be assessed using the Hirai Cancer Fatigue Scale. Outcomes will be assessed at baseline and after completion of the two-week intervention.
- Conditions
- Cancer
- Being tested
- Gamified Sleep Hygiene Education, Standard Sleep Hygiene Education
- Keywords
- Chemotherapy, Gamification, Sleep Hygiene, Sleep Quality, Cancer-Related Fatigue
- Medical subject headings
- Neoplasms, Sleep Hygiene, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Sleep Hygiene EducationBehavioural
Gamified sleep hygiene education will be delivered using the web-based "Sleep Hunter" educational material developed in an online escape-room format. The educational content includes sleep hygiene, stimulus control, caffeine use, screen light exposure, regulation of the sleep environment, relaxation exercises, breathing techniques, and establishment of a sleep routine. The program incorporates gamification elements including badges, levels, rewards, educational videos, audio narrations, visuals, animations, matching activities, fill-in-the-blank activities, and true/false questions. The intervention will be delivered using smartphones or tablets in two sessions over a two-week period. Each session will last no longer than 10 minutes, with a total education duration of approximately 20 minutes.
Standard Sleep Hygiene EducationBehavioural
Standard sleep hygiene education will be provided through verbal instruction and educational brochures in two sessions.
| Study group | Role | What they receive |
|---|---|---|
| Standard Sleep Hygiene Education Group | Active comparator | Participants in the control group will receive standard sleep hygiene education through verbal instruction and educational brochures in two sessions. Post-intervention assessments will be performed following completion of the education. Receives: Behavioral: Standard Sleep Hygiene Education |
| Gamified Sleep Hygiene Education Group | Experimental | Participants in the intervention group will receive gamified sleep hygiene education using the web-based "Sleep Hunter" educational material. The intervention will be delivered over a two-week period. The gamified education includes sleep hygiene content presented through an online escape-room format incorporating educational videos, audio narrations, visuals, animations, matching activities, fill-in-the-blank activities, and true/false questions Receives: Behavioral: Gamified Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Richards-Campbell Sleep Questionnaire Total Score
Sleep quality will be measured using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ yields a total score ranging from 0 to 100, with higher scores indicating better perceived sleep quality. The outcome will be the change in the RCSQ total score from baseline to the end of the 2-week intervention.
Measured: Baseline and immediately after completion of the 2-week intervention
Secondary outcomes (1)
Change in Hirai Cancer Fatigue Scale Total Score
Cancer-related fatigue will be measured using the Hirai Cancer Fatigue Scale. The scale consists of 15 items and yields a total score ranging from 15 to 75, with higher scores indicating greater cancer-related fatigue. The outcome will be the change in the total score from baseline to the end of the 2-week intervention.
Measured: Baseline and immediately after completion of the 2-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Nov 2026 (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.
- 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
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Esra Turker, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809386
- Sponsor's protocol ID
- 2025327
- Other IDs
- 1919B012551162
- Status last verified
- Sep 2026
- First submitted
- 29 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared to protect participant confidentiality and privacy. Aggregated study results will be reported in scientific publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gamified Sleep Hygiene Education on Sleep Quality and Fatigue Levels in Chemotherapy Patients
- ClinicalTrials.gov ID
- NCT07809386
- Acronym / sponsor ID
- 2025327
- Conditions
- Cancer
- Keywords
- Chemotherapy, Gamification, Sleep Hygiene, Sleep Quality, Cancer-Related Fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 9 Sep 2026 (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.
Sleep disturbances and fatigue are common problems among patients receiving chemotherapy and may negatively affect their quality of life. This randomized controlled trial aims to evaluate the effect of gamified sleep hygiene education on sleep quality and cancer-related fatigue in patients receiving chemotherapy.
A total of 56 patients will be randomly assigned to two groups, with 28 participants in each group. The intervention group will receive gamified sleep hygiene education through the web-based "Sleep Hunter" program, while the active comparator group will receive standard sleep hygiene education through verbal instruction and educational brochures. The intervention will be delivered in two sessions over a two-week period.
Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire, and cancer-related fatigue will be assessed using the Hirai Cancer Fatigue Scale. Outcomes will be assessed at baseline and after completion of the two-week intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Sleep Hygiene Education Group | Active comparator | Behavioral: Standard Sleep Hygiene EducationParticipants in the control group will receive standard sleep hygiene education through verbal instruction and educational brochures in two sessions. Post-intervention assessments will be performed following completion of the education. |
| Gamified Sleep Hygiene Education Group | Experimental | Behavioral: Gamified Sleep Hygiene EducationParticipants in the intervention group will receive gamified sleep hygiene education using the web-based "Sleep Hunter" educational material. The intervention will be delivered over a two-week period. The gamified education includes sleep hygiene content presented through an online escape-room format incorporating educational videos, audio narrations, visuals, animations, matching activities, fill-in-the-blank activities, and true/false questions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years or older
- Currently receiving chemotherapy
- Able to read and write in Turkish
- Able to communicate effectively
- Able to use a smartphone or tablet and access the web-based educational intervention
Key exclusion criteria (7 listed)
- Presence of a major mental disorder that may interfere with participation in the study
- Presence of a major visual, hearing, or communication impairment that may interfere with participation in the study
- Unable to read or write in Turkish
- Unable to use a smartphone or tablet or access the web-based educational intervention
- Previous diagnosis of a sleep disorder
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 Sleep Hygiene EducationGamified sleep hygiene education will be delivered using the web-based "Sleep Hunter" educational material developed in an online escape-room format. The educational content includes sleep hygiene, stimulus control, caffeine use, screen light exposure, regulation of the sleep environment, relaxation exercises, breathing techniques, and establishment of a sleep routine. The program incorporates gamification elements including badges, levels, rewards, educational videos, audio narrations, visuals, animations, matching activities, fill-in-the-blank activities, and true/false questions. The intervention will be delivered using smartphones or tablets in two sessions over a two-week period. Each session will last no longer than 10 minutes, with a total education duration of approximately 20 minutes. | Behavioural | Gamified Sleep Hygiene Education Group |
| Standard Sleep Hygiene EducationStandard sleep hygiene education will be provided through verbal instruction and educational brochures in two sessions. | Behavioural | Standard Sleep Hygiene Education Group |
Primary outcome
Change in Richards-Campbell Sleep Questionnaire Total Score
Time frame: Baseline and immediately after completion of the 2-week intervention
Sleep quality will be measured using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ yields a total score ranging from 0 to 100, with higher scores indicating better perceived sleep quality. The outcome will be the change in the RCSQ total score from baseline to the end of the 2-week intervention.
1 secondary outcome
Change in Hirai Cancer Fatigue Scale Total Score
Time frame: Baseline and immediately after completion of the 2-week intervention
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 9 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared to protect participant confidentiality and privacy. Aggregated study results will be reported in scientific publications and presentations.
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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 Sleep Hygiene Education and Standard Sleep Hygiene Education in people with Cancer, run by Lokman Hekim 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 8 inclusion and 7 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 9 Sep 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?
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 Esra Türker, Assoc. Prof. (+905074521224, esra.turker@lokmanhekim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Richards-Campbell Sleep Questionnaire Total Score (time frame: Baseline and immediately after completion of the 2-week intervention). 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 9 Sep 2026.