YOUEX: Exercise for Young Adults With Cancer

Sponsor
University Hospital Heidelberg (Other)
Overall Status
Completed
CT.gov ID
NCT05613699
Collaborator
Charite University, Berlin, Germany (Other), University Clinic Cologne (Other), University Clinic Essen (Other)
106
1
3
18.9
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise - Social Media
  • Behavioral: Exercise - App
  • Behavioral: Exercise - closed to patients residence
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Implementation and Evaluation of Physical Exercise Services for Young Adults With Cancer
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: supervised, group-based, online-social media exercise program

Behavioral: Exercise - Social Media
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.

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

Behavioral: Exercise - App
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.

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

Behavioral: Exercise - closed to patients residence
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)

Outcome Measures

Primary Outcome Measures

  1. Feasibility of the three exercise interventions [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 Outcome Measures

  1. Physical activity level [12 weeks and 24 weeks]

    Physical activity levels were determined by the standardized Godin-Shephard Leisure-Time Questionnaire. The questionnaire was used to ask for pre-diagnosis-, post-diagnosis- and pre-post-intervention physical activity levels within three categories: light, moderate and vigorous physical activity in minutes per week. Participants were categorized in an active and inactive subgroup with a threshold of 150 minutes moderate or 75 minutes vigorous physical activity per week (or the combination of both) based on the American College of Sports Medicine (ACSM) guidelines.

  2. Module Selection and preferences [Baseline, 6 weeks, 12 weeks]

    The individual module selection and preferences were queried and documented at the first three time points (Baseline, after 6 week and after 12 weeks). Reasons for any module selection and why other modules have not been selected were collected through open answer questions while multiple answers were possible. The subgroups of the initial module selection were analyzed according treatment and employment status. Further, we asked for module preferences under COVID-19 free conditions

  3. Impact of COVID-19 pandemic [Baseline, 6 weeks, 12 weeks, 24 weeks]

    The questionnaire about the impact of COVID-19 has been self-developed, but internal validated in other studies at the National Center of Tumor Diseases (NCT) Heidelberg. The COVID-19 questionnaire consisted of six items and surveyed the impact of COVID-19 on patient´s current job situation, leisure-time activities, physical activity levels, self-efficacy, anxiety and mental health. Further we asked for, whether COVID-19 had any effect on the participants module selection. The COVID-19 questionnaire was submitted later during the ongoing study due to COVID-19-lockdown in November 2020. Therefore, not all participants completed the COVID-19 questionnaire

  4. Fatigue [Baseline, 6 weeks, 12 weeks, 24 weeks]

    Standardized questionnaire used: European Organisation for Research and Treatment of Cancer (EORTC) FA (Fatigue) 12

  5. Health-related quality of life [Baseline, 6 weeks, 12 weeks, 24 weeks]

    Quality of life (QoL) will be assessed with the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It includes five multi-item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties.

  6. Distress [Baseline, 6 weeks, 12 weeks, 24 weeks]

    Standardized questionnaire used: National Comprehensive Cancer Network (NCCN) Distress-Thermometer

  7. Patient Satisfaction [Baseline, 6 weeks, 12 weeks, 24 weeks]

    Standardized questionnaire used: Zufriedenheit (ZUF)-8 Questionnaire

  8. Social Support [Baseline, 6 weeks, 12 weeks, 24 weeks]

    Standardized questionnaire used: German translation of the questionnaire by Sallis (1987)

  9. Fatigue Thermometer [Daily till week 12]

    Standardized questionnaire used: Style of NCCN Distress-Thermometer. Dimensions: Physical, emotional and mental Fatigue

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Center for Tumor Diseases Heidelberg Baden-Wuerttemberg Germany 69120

Sponsors and Collaborators

  • University Hospital Heidelberg
  • Charite University, Berlin, Germany
  • University Clinic Cologne
  • University Clinic Essen

Investigators

  • Principal Investigator: Joachim Wiskemann, PhD, Heidelberg University Hospital / National Center for Tumor Diseases

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joachim Wiskemann, Head Exercise Oncology, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT05613699
Other Study ID Numbers:
  • YOUEX_S932
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Joachim Wiskemann, Head Exercise Oncology, University Hospital Heidelberg
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2022