NCT05613699

Brief Summary

Over the past decade, importance of supportive care in cancer treatment of young cancer patients has increased. However, most common cancer-related side effects, such as physical deconditioning, psychological problems, infertility, and cancer-related fatigue, are particularly problematic for young adults (AYA). Short- and long-term side effects result in impaired quality of life, social life, and physical activity levels. While there is growing evidence that physical exercise is effective in reducing disease- or treatment-related side effects, programs are generally not tailored to the unique needs of young adults. In addition, social media or web-based programs are rarely structurally integrated into existing care programs. The objective of the Your Exercise Program (YOUEX) study is therefore to address these specific needs and to improve physical exercise services for young people in Germany. To this end, this pilot study presents three approaches to physical activity enhancement, with a particular focus on web-based and cross-regional programs. All three approaches will be evaluated for their feasibility and effectiveness on fatigue, distress, quality of life, and activity levels, as well as sustained effects over 24 weeks. The YOUEX study is an exploratory intervention study in the form of a 12-week exercise program for patients aged 18 to 39 years who currently have or have had a cancer diagnosis within the past 5 years. Eligible patients can choose from three support programs: Social Media Exercise Program, Online Exercise Platform, Supervised Exercise Program. The goal is to recruit 70 to 80 patients over an 8-month period. Evaluation questionnaires will be sent at three time points (T0: start of exercise program, T1: after 6 weeks; T2: after 12 weeks; T3: after 24 weeks) with a short weekly questionnaire between T0 and T2 to assess weekly adherence and changes in fatigue. YOUEX study will collect detailed information on the acceptability and feasibility of different physical activity programs for young people and their lasting effects on fatigue, quality of life and physical activity. Should these be positive, the findings can directly inform health care practice, which would be highly relevant especially in light of the COVID pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

October 17, 2022

Last Update Submit

November 4, 2022

Conditions

Keywords

cancersocial mediaexercisevirtual trainingapp

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the three exercise interventions

    Participants ability to follow the exercise prescription (measured by % of training frequency as well as type of the exercise)

    During 12 week of the intervention

Secondary Outcomes (9)

  • Physical activity level

    12 weeks and 24 weeks

  • Module Selection and preferences

    Baseline, 6 weeks, 12 weeks

  • Impact of COVID-19 pandemic

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Fatigue

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Health-related quality of life

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • +4 more secondary outcomes

Study Arms (3)

supervised, group-based, online-social media exercise program

OTHER
Behavioral: Exercise - Social Media

unsupervised individual home-based training with an online-training app

OTHER
Behavioral: Exercise - App

supervised, in-person exercise program close to place of residence

OTHER
Behavioral: Exercise - closed to patients residence

Interventions

The supervised online-social media exercise intervention took place once per week at a fixed, pre-scheduled time, via an online video conference platform. The training sessions lasted for 60 minutes and included a holistic workout with different focuses (e.g. resistance training for lower extremities, sensorimotor training, home-based endurance training). Patients were further recommended independent physical activity like walking or cycling, 1-2 times per week or to maintain the current volume of physical activity.

supervised, group-based, online-social media exercise program
Exercise - AppBEHAVIORAL

Exercise program in the online-app were personalized and focused on a combination of endurance and resistance training, 2-3 times a week, depending on patient's needs. Additional types of exercise (e.g. sensorimotor training) were added if therapy-related side effects were present. If necessary, exercise trainers conducted one introductory training session as video conference to check for exercise techniques and answer any individual questions.

unsupervised individual home-based training with an online-training app

The supervised exercise program close to patient's home was executed in a certified exercise facility of the network OnkoAktiv and supervised by special qualified exercise trainers. The weekly recommendation was to participate in a personalized in-person exercise program 1-2 per week, plus independent physical activity (or to maintain current level of physical activity)

supervised, in-person exercise program close to place of residence

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • cancer diagnosis within the past five years
  • signed informed consent

You may not qualify if:

  • cancer-related cognitive impairment
  • lack of sports clearance from the attending oncologist (e.g. in case of fragile bone metastases)
  • current participation in another exercise intervention
  • insufficient German language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Tumor Diseases

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (1)

  • Voland A, Krell V, Gotte M, Niels T, Koppel M, Wiskemann J. Exercise Preferences in Young Adults with Cancer-The YOUEX Study. Curr Oncol. 2023 Jan 21;30(2):1473-1487. doi: 10.3390/curroncol30020113.

MeSH Terms

Conditions

FatigueNeoplasmsMotor ActivityAlzheimer Disease

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Joachim Wiskemann, PhD

    Heidelberg University Hospital / National Center for Tumor Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Exercise Oncology

Study Record Dates

First Submitted

October 17, 2022

First Posted

November 14, 2022

Study Start

September 1, 2020

Primary Completion

September 30, 2021

Study Completion

March 31, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations