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Clinical Trials/NCT05613699
NCT05613699
Completed
Not Applicable

Implementation and Evaluation of Physical Exercise Services for Young Adults With Cancer

University Hospital Heidelberg1 site in 1 country106 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fatigue
Sponsor
University Hospital Heidelberg
Enrollment
106
Locations
1
Primary Endpoint
Feasibility of the three exercise interventions
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
March 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joachim Wiskemann

Head Exercise Oncology

University Hospital Heidelberg

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Feasibility of the three exercise interventions

Time Frame: During 12 week of the intervention

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

Secondary Outcomes

  • Health-related quality of life(Baseline, 6 weeks, 12 weeks, 24 weeks)
  • Physical activity level(12 weeks and 24 weeks)
  • Module Selection and preferences(Baseline, 6 weeks, 12 weeks)
  • Fatigue Thermometer(Daily till week 12)
  • Impact of COVID-19 pandemic(Baseline, 6 weeks, 12 weeks, 24 weeks)
  • Fatigue(Baseline, 6 weeks, 12 weeks, 24 weeks)
  • Patient Satisfaction(Baseline, 6 weeks, 12 weeks, 24 weeks)
  • Social Support(Baseline, 6 weeks, 12 weeks, 24 weeks)
  • Distress(Baseline, 6 weeks, 12 weeks, 24 weeks)

Study Sites (1)

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