NCT07274358

Brief Summary

This pilot feasibility study aims to assess the acceptability, usability, safety, and initial effects of the HopeMove mobile health app on fatigue in adolescents aged 13 to 18 years undergoing hematology-oncology treatment. HopeMove is a wearable-compatible app that offers guided home exercise sessions and daily symptom tracking to support physical activity and monitor well-being during treatment. The study includes an expert usability evaluation with 10 clinicians, a one-week usability testing phase with 15 adolescents, and an eight-week intervention period in which participants complete at least three exercise sessions per week using the app. Outcomes include usability measured with the Mobile Application Usability Scale, satisfaction assessed via a Visual Analog Scale, and fatigue evaluated with the Fatigue Scale. The findings are expected to provide evidence on the feasibility, usability, and potential clinical benefits of mobile-supported exercise programs for children and adolescents undergoing cancer treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
Last Updated

December 10, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 27, 2025

Last Update Submit

November 27, 2025

Conditions

Keywords

physical activity, fatigue, quality of life, mobile application

Outcome Measures

Primary Outcomes (2)

  • Mobile Application Usability

    Mobile application usability was evaluated prior to the pilot study by a panel of experts in pediatric oncology, digital health, and user-centered design. Experts assessed the HopeMove application using a standardized usability assessment form that examined clarity of content, ease of navigation, appropriateness for the target age group, visual design, responsiveness, and overall user experience. Feedback from experts was used to refine and optimize the application before initiating the pilot trial.

    Prior to the initiation of the pilot trial (single assessment during the development phase)

  • Fatigue

    Fatigue levels were assessed to evaluate the preliminary effectiveness of the HopeMove mobile application. Fatigue was measured using a standardized pediatric fatigue assessment tool administered before the intervention (at the initial meeting) and at the end of the 4-week feasibility period. Changes in fatigue scores were examined to explore whether engagement with the application was associated with improvements in perceived fatigue among participants.

    Baseline (initial meeting) and Week 4 (end of feasibility period)

Secondary Outcomes (1)

  • Satisfaction for Mobile Application

    Week 4 (end of feasibility period)

Study Arms (1)

Intervention Group-HopeMove Application Group

EXPERIMENTAL

Participants assigned to the HopeMove Application Group will use HopeMove, a mobile application designed to promote and support physical activity among pediatric hematology and oncology patients. During the 4-week feasibility period, participants are instructed to engage with the application at least 3 days per week, completing the guided physical activity sessions provided within the app.

Other: HopeMove Mobile Application

Interventions

HopeMove is a mobile application developed to promote physical activity and support wellbeing among pediatric hematology-oncology patients. The application provides age-appropriate guided exercise sessions, motivational prompts, visual progress tracking, and individualized activity suggestions tailored to each participant's needs and abilities. During the feasibility study, participants were instructed to engage with the HopeMove application at least three days per week for a total duration of four weeks. Each session included structured physical activity modules designed to be safe and achievable during hospitalization or home recovery. The intervention focused on feasibility, usability, acceptability, and preliminary effects on outcomes such as fatigue and satisfaction. No masking was applied due to the nature of the digital intervention.

Intervention Group-HopeMove Application Group

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • adolescents aged 13-18 years
  • receiving active hematology-oncology treatment
  • able to use a smartphone running Android operating system
  • has internet access
  • voluntarily agrees to participate
  • parent/guardian consent obtained (if applicable)
  • able to perform light-moderate exercise
  • able to complete at least 75% of planned exercise sessions

You may not qualify if:

  • having a chronic illness requiring regular invasive procedures,
  • having received analgesics within the past 2 hours,
  • having experienced a seizure within the past 2 hours,
  • using antiepileptic medication,
  • having a body temperature above 37.5°C
  • not having parental consent,
  • being agitated at the time of the procedure,
  • having any auditory or visual impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityFatigue

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Masking was not applied due to the nature of the intervention, and all participants and investigators were aware of the intervention being delivered.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single-arm pilot feasibility study in which all participants receive the HopeMove intervention without a comparison group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching and Research Assistant

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 10, 2025

Study Start

August 1, 2025

Primary Completion

November 15, 2025

Study Completion

November 15, 2025

Last Updated

December 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the dataset contains identifiable health information of pediatric participants, and sharing is restricted to protect patient privacy in accordance with ethical and legal requirements.

Locations