NCT07809386

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
2mo left

Started Sep 2026

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Sep 2026Nov 2026

First Submitted

Initial submission to the registry

May 29, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

May 29, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

ChemotherapyGamificationSleep HygieneSleep QualityCancer-Related Fatigue

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and immediately after completion of the 2-week intervention

Secondary Outcomes (1)

  • Change in Hirai Cancer Fatigue Scale Total Score

    Baseline and immediately after completion of the 2-week intervention

Study Arms (2)

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.

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

Behavioral: Gamified Sleep Hygiene Education

Interventions

Standard sleep hygiene education will be provided through verbal instruction and educational brochures in two sessions.

Standard Sleep Hygiene Education Group

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.

Gamified Sleep Hygiene Education Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University Ankara Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsSleep HygieneSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Esra Türker, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 29, 2026

First Posted

September 9, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations