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Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology. (BEPPO)

8 settembre 2026 aggiornato da: Miriam Götte, Universität Duisburg-Essen

Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology (Evaluation BEwegungs- Und sPorttherapeutischer Interventionen Unter Medizinischer Therapie in Der Pädiatrischen Onkologie)

The BEPPO study is a Germany-wide clinical trial investigating whether a structured exercise program can improve physical and mental health in children and adolescents undergoing cancer treatment. Although exercise is known to support recovery and well-being, it is not yet a standard part of pediatric oncology care. The study aims to generate evidence to support the integration of exercise into routine treatment.

A total of 346 patients aged 3 to 18 years are recruited across 13 pediatric oncology centers in Germany. Participants are randomly assigned to either an exercise intervention group or a standard care control group.

Children in the intervention group take part in a 6-month individualized exercise program with 3-5 sessions per week. The program is delivered across different settings, including inpatient hospital care, outpatient treatment, and home-based training supported by telemedicine. This ensures continuous support throughout the course of medical treatment.

In addition to supervised exercise sessions, participants receive four structured counseling sessions. These sessions aim to strengthen motivation, address individual barriers to participation, and support long-term engagement in physical activity. The counseling also helps build a strong therapeutic relationship and promotes adherence to the program.

The exercise intervention is based on established principles of sports science but is individually adapted to each patient's health status, treatment phase, and personal preferences. Each training session follows a structured plan with specific goals, while also considering individual physical and psychological conditions to ensure safety, feasibility, and effectiveness.

The main objective of the BEPPO study is to improve physical performance, particularly leg strength, which is the primary endpoint. Secondary outcomes include endurance, functional mobility, balance, physical activity levels, fatigue, quality of life, mental well-being, frailty, and treatment-related symptoms and side effects.

In addition to clinical effectiveness, the study also evaluates how well the intervention can be implemented in routine healthcare settings. This includes assessing adherence, feasibility, and potential barriers and facilitators for integrating exercise into standard care. A health economic evaluation is also conducted in collaboration with health insurance providers to determine cost implications.

Overall, the BEPPO study aims to provide robust scientific evidence on the benefits and feasibility of structured exercise during pediatric cancer treatment. The long-term goal is to establish exercise as a standard component of supportive care in pediatric oncology, improving both short- and long-term outcomes for patients.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

346

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Germania
      • Berlin, Germania
        • Reclutamento
        • Charité-Universitätsmedizin Berlin, Department of Pediatric Oncology/Hematology
        • Contatto:
      • Bonn, Germania
        • Reclutamento
        • University of Bonn Medical Center, Department of Pediatric Hematology/Oncology,
        • Contatto:
      • Cologne, Germania
        • Reclutamento
        • Children's Hospital Amsterdamer Straße, ; Clinic for Children and Youth Medicine; Department for pediatric hematology/oncology
        • Contatto:
      • Cologne, Germania
        • Reclutamento
        • University Hospital Cologne, Department of Pediatric Oncology and Hematology, Children's Hospital
        • Contatto:
      • Essen, Germania
        • Reclutamento
        • University Hospital Essen, Department of Pediatric Hematology/Oncology, Center for Child and Adolescent Medicine, Clinic for Pediatrics III
        • Contatto:
      • Frankfurt, Germania
      • Hamburg, Germania
        • Reclutamento
        • Universitätsklinikum Hamburg-Eppendorf, Department of Pediatric Hematology and Oncology, Hubertus Wald Tumor Center, University Cancer Center Hamburg
        • Contatto:
          • Gabriele Escherich
          • Numero di telefono: 0049 40 7410 53796
          • Email: escherich@uke.de
        • Contatto:
          • Simon Elmers
          • Numero di telefono: 0049 40 7410 52624
          • Email: s.elmers@uke.de
      • Jena, Germania
        • Reclutamento
        • Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
        • Contatto:
      • Mainz, Germania
        • Reclutamento
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Department of Pediatric Hematology/Oncology
        • Contatto:
      • München, Germania
        • Reclutamento
        • Pädiatrische Hämatologie und Onkologie, Zelltherapie Zentrum für Kinder- und Jugendmedizin Eine Kooperation der München Klinik und des TUM Klinikums
        • Contatto:
      • Nuremberg, Germania
        • Reclutamento
        • DIAKONEO Klinik Hallerwiese-Cnopfsche Kinderklinik Nürnberg, Department of Pediatric Hematology and Oncology
        • Contatto:
      • Stuttgart, Germania
      • Ulm, Germania

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Patients aged ≥3 and ≤18 years
  • Oncological diagnosis with curative treatment intent
  • ≤6 weeks since cancer diagnosis (diagnosis can be initial, secondary or relapse diagnosis)
  • Information and consent procedures feasible in German, English or with using local site resources (e.g., interpreters or multilingual staff)
  • Communication with the patient is possible in German, English or with using local site resources (e.g., interpreters or multilingual staff) during the assessments and intervention
  • Patients insured by German statutory health insurers

Exclusion Criteria:

  • Patients aged <3 and >18 years
  • No active medical oncological treatment (e.g., watch-and-wait strategy, surgery without ongoing oncological acute treatment at a pediatric oncology center)
  • Medical limitations that do not allow implementation of the study protocol
  • Life expectancy < 6 months
  • Patients not insured by German statutory health insurers (e.g., Privatly insured patients, self-paying patients)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: BEPPO-group

Patients in the BEPPO group participate in 3-5 partially standardized, supervised exercise sessions per week (30 minutes each), aiming for at least 78 sessions during the 6-month intervention period. Sessions are delivered in hospital settings (inpatient ward, outpatient clinic, or day clinic) and online during periods at home.

Exercises are individually adapted to age, health status, treatment phase, and interests.Primary focus are endurance and strength exercises, additionally coordination, flexibility, and balance exercises. Treatment-related side effects are continuously considered. Online sessions are delivered via video platforms; alternatively, individualized home exercise plans are provided.

Additionally, patients and families participate in four family-centered exercise counselling sessions to identify barriers and facilitators to physical activity, define individualized goals, and support long-term adherence through increaseing patients intrinsic motivation.
Comportamentale: Partially-standardised, supervised, continuity-of-care exercise intervention

Exercise sessions:

3-5x/week over 6 months (minimum of 78 sessions in total), duration: 30 minutes, partially-standardised with a primarily focus on strength and endurance exercises, additional components: coordination, flexibility, and balance exercises, supervised by exercise professionals, continuity-of-care achieved through hospital-based (in-patient/out-patient), and home-based online sessions

Exercise counselling:

4x sessions in 12 months, family-centred exercise counselling, primary focus on understanding barriers and facilitators to physical activity and increasing intrinsic motivation for participating in the exercise session
Nessun intervento: Control group

Patients in the control group do not receive a standardized exercise intervention but may participate in the existing site-specific exercise-related usual care services offered at their respective study sites.

The availability and extent of these services vary considerably across the 13 participating study sites, ranging from no exercise support to comprehensive hospital-based exercise programs during intensive cancer treatment, depending on local staffing and structural resources.

Existing exercise programs are delivered exclusively within the hospital setting (inpatient ward, outpatient clinic, or day clinic) and are based on local practice rather than a standardized intervention protocol.

Neither online exercise support during periods at home nor structured exercise counselling sessions are part of usual care at any participating study site.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximal leg extensor strength
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Measured using a CITEC handheld dynamometer on the dominant side unless medically contraindicated. Patients are positioned prone with the knee flexed to 90°; if lying prone is not possible for medical reasons, the assessment is performed in a seated position. The dynamometer is placed anteriorly at the distal lower leg (shin). Outcome measure: maximal muscle strength (Newton; range 0.0-500.0). Interpretation: Higher values indicate greater muscle strength.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximal handgrip strength
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Measured using a CITEC handheld dynamometer with a fist-grip applicator on the dominant side (unless medically contraindicated; in this case, the non-dominant side is assessed at all time points). Patients are seated with the elbow flexed to 90°. The dynamometer is placed in the patient's fist. Outcome measure: maximal muscle strength (Newton; range 0.0-500.0). Interpretation: Higher values indicate greater muscle strength.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Maximal dorsiflexor strength
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement
Maximal arm flexion strength
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Measured using a CITEC handheld dynamometer on the dominant side (unless medically contraindicated; in this case, the non-dominant side is assessed at all time points). Patients are lying down on their back with the elbow flexed at 90°. The dynamometer is placed at the patient's wrist. Outcome measure: maximal muscle strength (Newton; range 0.0-500.0). Interpretation: Higher values indicate greater muscle strength.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Sit and Reach Test (Mobility of the torso and lower back)
Lasso di tempo: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Measured using a Sit-and-Reach Box (Baseline). Patients are seated on the floor with their legs straight and their feet positioned against the box. The patient leans forward with both hands while keeping the legs straight, reaching as far forward as possible without changing the leg position, and moves the sliding device forward with the fingertips. The end position must be held for 2 seconds. No bouncing or jerking movements are allowed; only pain-free movements are permitted. Measurement is taken at the endpoint.

Outcome measure: Forward lean in cm (Range: 6-59 cm). Interpretation: Higher values indicate greater flexibility.
At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Tandem Stand (10s, eyes-open)
Lasso di tempo: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Measured using the Tandem Stand test. Patients are instructed to stand with one foot directly in front of the other, with the heel of the front foot touching the toes of the back foot. Arms are positioned comfortably at the sides of the body. Patients are asked to maintain this position for 10 seconds without moving the feet or requiring external support.

Outcome measure: Time (seconds) maintained in tandem stance (Range: 0-10 seconds).

Interpretation: Higher values indicate better balance.
At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Tandem Stand (10s, eyes-closed)
Lasso di tempo: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Measured using the Tandem Stand test with eyes closed. Patients are instructed to stand with one foot directly in front of the other, with the heel of the front foot touching the toes of the back foot. Once a stable position is achieved, patients close their eyes and are asked to maintain the position for 10 seconds without moving the feet, opening the eyes, or requiring external support.

Outcome measure: Time (seconds) maintained in tandem stance with eyes closed (Range: 0-10 seconds).

Interpretation: Higher values indicate better balance.
At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Single-leg Stance (10s)
Lasso di tempo: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Measured using the Single-Leg Stance test. Patients are instructed to stand on one leg with their eyes open while keeping the other foot off the ground. Arms are positioned comfortably at the sides of the body. Patients are asked to maintain the position for up to 10 seconds without touching the raised foot to the ground, moving the stance foot, or requiring external support. Time is recorded at the endpoint, with a maximum score of 10 seconds.

Outcome measure: Time (seconds) maintained in single-leg stance (Range: 0-10 seconds).

Interpretation: Higher values indicate better balance.
At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Sit to Stand (5x STS)
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Measured using the Five Times Sit-to-Stand Test (5xSTS). The starting position is seated on a chair with the knees flexed to 90°. Arms are crossed in front of the body, with the hands touching the opposite shoulders, to restrict arm movements. Patients are instructed to stand up fully and sit down again as quickly as possible for a total of five repetitions. Timing starts on the command "Go" and stops when the patient reaches the standing position at the end of the fifth repetition.

Outcome measure: Time to complete five sit-to-stand repetitions (seconds).

Interpretation: Lower values indicate better functional lower-extremity strength and mobility.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Timed up and go (TUG 3m)
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Measured using the Timed Up and Go (TUG) Test. The starting position is seated on a chair with the knees flexed to 90°. Arms are crossed in front of the body, with the hands touching the opposite shoulders, to restrict arm movements. Patients are instructed to stand up from the chair, walk 3 meters at a comfortable and safe pace, turn around, walk back to the chair, and sit down again. Timing starts on the command "Go" and stops when the patient is seated again.

Outcome measure: Time to complete the Timed Up and Go test (seconds).

Interpretation: Lower values indicate better functional mobility and dynamic balance.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
2-Minute Walking Test (2MWT)
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Measured using the 2-Minute Walk Test (2MWT). Patients are instructed to walk back and forth along a 15-meter walkway for a duration of 2 minutes. They are encouraged to walk as far as possible at a self-selected, comfortable and safe pace. Rest breaks are permitted if needed, but the timer continues to run. The total distance covered within the 2-minute period is recorded.

Outcome measure: Distance walked in 2 minutes (meters).

Interpretation: Higher values indicate better functional walking capacity and endurance.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Body Mass Index (in Percentiles)
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

BMI is calculated from body weight and height and expressed in percentiles. Body weight (kg) and body height (m) are measured using standard procedures. Body Mass Index (BMI) is calculated as weight divided by height squared (kg/m²). BMI values are then converted into age- and sex-specific percentiles.

Outcome measure: BMI percentile.

Interpretation: Higher percentiles indicate higher relative body mass compared to age- and sex-matched reference populations.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Waist-to-hip ratio (WHR)
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Waist-to-hip ratio (WHR) is calculated from waist and hip circumferences. Waist circumference is measured at the narrowest point between the lower costal margin and the iliac crest, and hip circumference is measured at the widest point over the buttocks, using a standardized measuring tape. Both measurements are taken in a standing position. Waist-to-hip ratio is calculated by dividing waist circumference by hip circumference.

Outcome measure: Waist-to-hip ratio (unitless).

Interpretation: Higher values indicate a greater proportion of abdominal fat distribution.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Estimate body fat and lean mass
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Estimations are based on triceps skinfold thickness which is measured using a skinfold caliper (Harpender). The measurement is taken at the midpoint between the acromion and the olecranon process on the posterior side of the upper arm. The skinfold is grasped firmly between thumb and index finger, and the caliper is applied perpendicular to the fold approximately 1 cm below the fingers. The measurement is taken after the caliper reading stabilizes. Measured only on healthy skin.

Outcome measure: Triceps skinfold thickness (mm).

Interpretation: Higher values indicate greater subcutaneous fat mass.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Objective physical activity
Lasso di tempo: At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Measured using a Movisens monitor (Move4) over a 7-day period. Participants are instructed to wear the Movisens monitor continuously for 7 consecutive days during waking hours, removing it only for water-based activities if required. The device records habitual physical activity under free-living conditions. Data are collected over the full monitoring period and processed according to standardized algorithms.

Outcome measure: Objective physical activity over 7 days (amongst others minutes of moderate-to-vigorous physical activity).

Interpretation: Higher values indicate higher levels spend in moderate-to-vigorous physical activity.
At baseline (T0), and at 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Subjective physical activity levels
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Subjective physical activity level is assessed using the ActiOn! questionnaire. The ActiOn! questionnaire is based on the KiGGS questionnaire and has been adapted to reflect the daily reality of children with cancer undergoing intensive therapy. It is used to capture subjective physical activity before, during and after treatment.

Outcome measure: Subjective physical activity level (questionnaire-based score) measured by minutes of (moderate to vigorous) activity per week/per day in different setting, MET-hours.

Interpretation: Higher score indicate high activity levels.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Health-related quality of life
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Assessed using the Pediatric Quality of Life Inventory (PedsQL), specifically the PedsQL 4.0 Generic Core Scales Short Form (SF15), supplemented with the Cancer module. The instrument is designed for children and adolescents and captures the dimensions of physical, emotional, social, and school (or cognitive) functioning. This questionnaire is assessed in participants and their caregivers. The combined questionnaires consist of a total of 42 closed-ended items.

Outcome measure: Health-related quality of life (PedsQL score).

Interpretation: Higher scores indicate better Health-related quality of life.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Fatigue
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Assessed using the Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale (PedsQL 3.0). The questionnaire consists of 18 closed-ended items and is used to evaluate fatigue symptoms in children and adolescents. This questionnaire is assessed in participants and their caregivers. It captures three subscales: general fatigue, sleep/rest-related fatigue, and cognitive fatigue.

Outcome measure: Fatigue score (total and subscale scores).

Interpretation: Higher scores indicate lower fatigue.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Mental well-being
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Assessed using the WHO-5 Well-Being Index (WHO-5). This psychometric instrument is used to measure general well-being and psychological health. The questionnaire consists of five items, each rated on a 6-point Likert scale.

Outcome measure: WHO-5 well-being sum score.

Interpretation: Higher scores indicate higher well-being.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Symptoms and side effects during cancer therapy
Lasso di tempo: At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.

Assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The instrument is used to standardize the assessment of prevalent symptoms during cancer therapy. This questionnaire is assessed in participants and their caregivers. In the BEPPO study the following 10 items are assessed: decreased appetite, constipation, diarrhea, shortness of breath, heart palpitation, numbness & tingling, dizziness, insomnia, falls, muscle weakness.

Outcome measure: Symptom burden (PRO-CTCAE item scores).

Interpretation: Occurance of symptomatic toxicities. Evaluation per item, higher value indicates higher severity.
At baseline (T0), and at 3 months (T1), 6 months (T2), and 12 months (T3) after baseline. Additional assessment: at the end of acute medical treatment (Tx), provided this time point does not fall within 4 weeks of another scheduled measurement.
Cost-effectiveness of BEPPO compared to standard care in terms of incremental costs per muscle strength, physical activity or health-related quality of life
Lasso di tempo: From baseline (T0) up to the end of the active study period (clinical follow-up at T3)
Assessing the cost-effectiveness of BEPPO compared to standard care in terms of incremental costs per muscle strength, physical activity or health-related quality of life.
From baseline (T0) up to the end of the active study period (clinical follow-up at T3)
Cost-utility of BEPPO compared to standard care in terms of costs per quality-adjusted life year [QALY]
Lasso di tempo: From baseline (T0) up to the end of the active study period (T3; clinical follow-up)
Assessing the cost-utility of BEPPO compared to standard care in terms of costs per quality-adjusted life year [QALY]
From baseline (T0) up to the end of the active study period (T3; clinical follow-up)
Implementation outcome via formative evaluation
Lasso di tempo: up to 18 months
Formative evaluation regarding the implementation will be conducted using qualitative analysis of semi-structured interviews
up to 18 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universität Duisburg-Essen

Collaboratori

Charite University, Berlin, Germany
University Hospital, Essen
University of Cologne
Johann Wolfgang Goethe University Hospital
University Hospital, Bonn
Technical University of Munich
Johannes Gutenberg University Mainz
Universitätsklinikum Hamburg-Eppendorf
University Hospital Ulm
Jena University Hospital
University of Regensburg
Klinikum Stuttgart
Techniker Krankenkasse
DAK Gesundheit
AOK Rheinland/Hamburg
BARMER Krankenkasse
University Hospital Cologne
Children's University Hospital Cologne, Germany
Klinik Hallerwiese-Cnopfsche Kinderklink

Investigatori

  • Cattedra di studio: Miriam Goette, Institut for Movement and Exercise, West German Cancer Center, University Hospital Essen, Essen, Germany
  • Cattedra di studio: Freerk T Baumann, Department I of Internal Medicine, Center for Integrated Oncology Cologne Bonn, University Hospital of Cologne, Cologne, Germany

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

9 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

15 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 settembre 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BEPPO_01NVF24318
  • 01NVF24318 (Altro numero di sovvenzione/finanziamento: Innovations Fund of the Federal Joint Committee (G-BA), Germany)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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