CClinicalTrials.gg
Active, not recruitingNCT04328038PEXOUpdated Feb 3, 2025

Personalized Exercise Oncology

An observational study in Cancer and Health Behavior, sponsored by University Hospital Heidelberg. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by University Hospital Heidelberg · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study summary

The Goal of the study is to identify trait-homogenous groups of cancer patients in regards to their physical activity associated health literacy. Based on these Groups, individualized exercise protocols and educative strategies can be developed which may increase the efficacy of the exercise therapy and increases the likelihood that patient get involved in physical activity.

02

Conditions studied

  • Cancer
  • Health Behavior

Keywords

  • Physical Activity
  • Exercise
  • Health literacy
  • cancer-related symptoms
  • treatment-related symptoms
  • personalized Medicine
03

In context

Lead sponsor

University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Mixed Cohort of adult cancer patients undergoing treatment Special Subgroup: Multiple Myeloma Patients

Inclusion criteria

  • Histologically confirmed cancer diagnosis
  • Females and males ≥18 years of age
  • Undergoing either chemo-, immune-, radio- or anti-hormonal treatment
  • Last surgery more than 6 weeks in the past
  • Ability to understand English or German
  • Be able to provide and understand informed consent
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Score of ≤ 2

Exclusion criteria

Exclusion Criteria:

  • Heart insufficiency > NYHA III (New York Heart Association) or uncertain arrhythmia
  • Uncontrolled hypertension
  • Severe renal dysfunction (GFR \< 30%, Creatinine> 3mg/dl)
  • Reduced standing or walking
  • Current pregnancy
  • Any other evidence in the medical record of an absolute contraindication for exercise
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • USA

    Cohort from the USA

    Other: Survey

  • Germany

    Cohort from Germany

    Other: Survey

Interventions

  • OtherSurvey

    Patient fill out a survey containing: Demographic Information, medical history, several Questionnaires about Health Literacy, Well Being/HRQoL and Fatigue

06

What researchers measure

Primary outcomes

  1. Patient Clusters

    Identification of different, trait-homogenous patient clusters

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Questionnaire: Physical Activity Associated Health Literacy

    To assess physical activity-associated health competence the recently developed and validated questionnaire from Sudeck and Pfeifer (2016) will be used

    Time frame: through study completion, an average of 1 year

  2. Questionnaire: Health Literacy

    To assess health-literacy the recently developed and validated questionnaire from Sudeck and Pfeifer (2016) will be used

    Time frame: through study completion, an average of 1 year

  3. Questionnaire: Health Related Quality of Life

    Quality of Life will be assessed with the validated 30-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0).

    Time frame: through study completion, an average of 1 year

  4. Questionnaire: Fatigue

    To asses fatigue patients will be asked to complete the 12-item EORTC QLQ-FA12 (FA = fatigue), which is a newly developed questionnaire which has been intensively validated

    Time frame: through study completion, an average of 1 year

  5. Questionnaire: Physical Activity

    Patient's level of physical activity will be assessed with the SQUASH Physical Activity Questionnaire. It includes multiple activities referring to a 'normal' week. Activity dimensions asked include actively commuting physical activity (walking, cycling), physical activity at work or school, household activities, leisure time activities (sports, walking, gardening, cycling).

    Time frame: through study completion, an average of 1 year

  6. Questionnaire: Emotion Thermometers

    Emotion thermometers are four-domain visual-analogue scale including distress, anxiety, depression, and anger. Each domain is rated on an 11-point (0 to 10) Likert scale

    Time frame: through study completion, an average of 1 year

  7. Questionnaire: Brief Pain Inventory (BPI)

    Bone pain will be assessed with the Brief Pain Inventory (BPI). This is a valid and reliable tool for pain measurement in cancer patients with bone metastases. It measures both pain severity and pain interference on function

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Heidelberg University Hospital
    Heidelberg, 69120, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04328038
Lead sponsor
University Hospital Heidelberg
Collaborators
Penn State University
Responsible party
Joachim Wiskemann (Head of Exercise Onoclogy, Principal Investigator, Associated Professor, University Hospital Heidelberg) — Principal investigator
First posted
Mar 31, 2020
Start date
Nov 26, 2018
Primary completion
Dec 2025 (estimated)
Completion
Feb 2026 (estimated)
Last update
Feb 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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