Exercise for Young Adults With Cancer

NCT ID: NCT05613699

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fatigue Cancer Physical Activity Exercise

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

Group Type OTHER

Exercise - Social Media

Intervention Type BEHAVIORAL

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.

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

Group Type OTHER

Exercise - App

Intervention Type BEHAVIORAL

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.

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

Group Type OTHER

Exercise - closed to patients residence

Intervention Type BEHAVIORAL

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)

Interventions

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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.

Intervention Type 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.

Intervention Type 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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

University Clinic Cologne

UNKNOWN

Sponsor Role collaborator

University Clinic Essen

UNKNOWN

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Joachim Wiskemann

Head Exercise Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joachim Wiskemann, PhD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University Hospital / National Center for Tumor Diseases

Locations

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National Center for Tumor Diseases

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 36826074 (View on PubMed)

Other Identifiers

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YOUEX_S932

Identifier Type: -

Identifier Source: org_study_id

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