Exercise for Young Adults With Cancer (YOUEX)
Primary Purpose
Fatigue, Cancer, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise - Social Media
Exercise - App
Exercise - closed to patients residence
Sponsored by
About this trial
This is an interventional supportive care trial for Fatigue focused on measuring cancer, social media, exercise, virtual training, app
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
Sites / Locations
- National Center for Tumor Diseases
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
supervised, group-based, online-social media exercise program
unsupervised individual home-based training with an online-training app
supervised, in-person exercise program close to place of residence
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Physical activity level
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.
Module Selection and preferences
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
Impact of COVID-19 pandemic
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
Fatigue
Standardized questionnaire used: European Organisation for Research and Treatment of Cancer (EORTC) FA (Fatigue) 12
Health-related quality of life
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.
Distress
Standardized questionnaire used: National Comprehensive Cancer Network (NCCN) Distress-Thermometer
Patient Satisfaction
Standardized questionnaire used: Zufriedenheit (ZUF)-8 Questionnaire
Social Support
Standardized questionnaire used: German translation of the questionnaire by Sallis (1987)
Fatigue Thermometer
Standardized questionnaire used: Style of NCCN Distress-Thermometer. Dimensions: Physical, emotional and mental Fatigue
Full Information
NCT ID
NCT05613699
First Posted
October 17, 2022
Last Updated
November 4, 2022
Sponsor
University Hospital Heidelberg
Collaborators
Charite University, Berlin, Germany, University Clinic Cologne, University Clinic Essen
1. Study Identification
Unique Protocol Identification Number
NCT05613699
Brief Title
Exercise for Young Adults With Cancer
Acronym
YOUEX
Official Title
Implementation and Evaluation of Physical Exercise Services for Young Adults With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg
Collaborators
Charite University, Berlin, Germany, University Clinic Cologne, University Clinic Essen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Cancer, Physical Activity, Exercise
Keywords
cancer, social media, exercise, virtual training, app
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
supervised, group-based, online-social media exercise program
Arm Type
Other
Arm Title
unsupervised individual home-based training with an online-training app
Arm Type
Other
Arm Title
supervised, in-person exercise program close to place of residence
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Exercise - Social Media
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise - App
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise - closed to patients residence
Intervention Description
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)
Primary Outcome Measure Information:
Title
Feasibility of the three exercise interventions
Description
Participants ability to follow the exercise prescription (measured by % of training frequency as well as type of the exercise)
Time Frame
During 12 week of the intervention
Secondary Outcome Measure Information:
Title
Physical activity level
Description
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.
Time Frame
12 weeks and 24 weeks
Title
Module Selection and preferences
Description
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
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Impact of COVID-19 pandemic
Description
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
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Fatigue
Description
Standardized questionnaire used: European Organisation for Research and Treatment of Cancer (EORTC) FA (Fatigue) 12
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Health-related quality of life
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Distress
Description
Standardized questionnaire used: National Comprehensive Cancer Network (NCCN) Distress-Thermometer
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Patient Satisfaction
Description
Standardized questionnaire used: Zufriedenheit (ZUF)-8 Questionnaire
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Social Support
Description
Standardized questionnaire used: German translation of the questionnaire by Sallis (1987)
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Fatigue Thermometer
Description
Standardized questionnaire used: Style of NCCN Distress-Thermometer. Dimensions: Physical, emotional and mental Fatigue
Time Frame
Daily till week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Wiskemann, PhD
Organizational Affiliation
Heidelberg University Hospital / National Center for Tumor Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Tumor Diseases
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Exercise for Young Adults With Cancer
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