HopeMove App in Pediatric Cancer Patients

NCT ID: NCT07274358

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-11-15

Brief Summary

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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.

Detailed Description

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Adolescents undergoing cancer treatment often face declines in physical function, decreased physical activity, and cancer-related fatigue, all of which negatively impact their quality of life and treatment adherence. Reduced activity and extended hospital stays can worsen fatigue and emotional distress, limiting daily activities and overall well-being. Exercise-based supportive care programs have proven beneficial in pediatric oncology, but access to structured, developmentally suitable options remains limited. Mobile health solutions are emerging as a way to support physical activity and symptom monitoring through accessible digital platforms.

HopeMove is a mobile app designed to encourage physical activity and symptom tracking among adolescents aged 13-18 years receiving hematology-oncology treatment. The app features short guided exercise videos, daily symptom diaries, weekly activity summaries, and compatibility with wearable devices.

The evaluation was carried out in three successive phases. First, 10 clinical experts reviewed the app using the Mobile Application Usability Scale to evaluate clarity, usability, and clinical appropriateness. Next, 15 adolescents participated in a one-week usability test, during which they used the app and provided structured feedback. In addition to quantitative usability scores, adolescents completed an 8-item open-ended interview developed by the research team to assess ease of use, clarity of instructions, comfort during exercise, content relevance, and expectations. Feedback from experts and adolescents was combined to improve the app before proceeding.

In the third phase, the same 15 adolescents used HopeMove over eight weeks. They were instructed to complete at least three guided exercise sessions weekly, with the option for additional sessions. During the intervention, adolescents also performed daily in-app symptom check-ins responding to "How do you feel today?" with a visual rating scale to record their overall perceived condition each day. Fatigue was measured at baseline and after the intervention using the Fatigue Scale, and satisfaction was assessed with a Visual Analog Scale. Adherence, usability, and safety were monitored throughout, with no adverse events reported.

This pilot feasibility study aims to assess the usability, acceptability, safety, and preliminary clinical effects of the HopeMove app in adolescents receiving hematology-oncology treatment. Results are expected to provide evidence supporting the potential benefits of mobile app-based exercise interventions for children and adolescents undergoing cancer treatment and to inform the design of future controlled trials.

Conditions

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Physical Activity Mobile Application

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm pilot feasibility study in which all participants receive the HopeMove intervention without a comparison group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Masking was not applied due to the nature of the intervention, and all participants and investigators were aware of the intervention being delivered.

Study Groups

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Intervention Group-HopeMove Application Group

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.

Group Type EXPERIMENTAL

HopeMove Mobile Application

Intervention Type OTHER

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.

Interventions

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HopeMove Mobile Application

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 Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role collaborator

Koç University

OTHER

Sponsor Role lead

Responsible Party

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Eysan Hanzade Umac

Teaching and Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KOCUN

Identifier Type: -

Identifier Source: org_study_id

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