Clinical trial NCT05613699: Exercise for Young Adults With Cancer
Official title: Implementation and Evaluation of Physical Exercise Services for Young Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Cancer
Physical Activity
Exercise
Keywords: cancer
social media
exercise
virtual training
app
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: University Clinic Cologne
name: University Clinic Essen
First posted: 2022-11-14
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Feasibility of the three exercise interventions
timeFrame: During 12 week of the intervention
Secondary outcomes:
measure: Physical activity level
timeFrame: 12 weeks and 24 weeks
measure: Module Selection and preferences
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Impact of COVID-19 pandemic
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Fatigue
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Health-related quality of life
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Distress
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Patient Satisfaction
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Social Support
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Fatigue Thermometer
timeFrame: Daily till week 12
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: National Center for Tumor Diseases
state: Baden-Wuerttemberg
Study officials:
affiliation: Heidelberg University Hospital / National Center for Tumor Diseases
name: Joachim Wiskemann, PhD
role: PRINCIPAL_INVESTIGATOR
References: