Personalized Exercise Oncology (PEXO)

January 30, 2025 updated by: Joachim Wiskemann, University Hospital Heidelberg

Personalized Exercise Oncology (PEXO) - Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Heidelberg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
USA
Cohort from the USA
Other: Survey
Patient fill out a survey containing: Demographic Information, medical history, several Questionnaires about Health Literacy, Well Being/HRQoL and Fatigue
Germany
Cohort from Germany
Other: Survey
Patient fill out a survey containing: Demographic Information, medical history, several Questionnaires about Health Literacy, Well Being/HRQoL and Fatigue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Clusters
Time Frame: through study completion, an average of 1 year
Identification of different, trait-homogenous patient clusters
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire: Physical Activity Associated Health Literacy
Time Frame: through study completion, an average of 1 year
To assess physical activity-associated health competence the recently developed and validated questionnaire from Sudeck and Pfeifer (2016) will be used
through study completion, an average of 1 year
Questionnaire: Health Literacy
Time Frame: through study completion, an average of 1 year
To assess health-literacy the recently developed and validated questionnaire from Sudeck and Pfeifer (2016) will be used
through study completion, an average of 1 year
Questionnaire: Health Related Quality of Life
Time Frame: through study completion, an average of 1 year
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).
through study completion, an average of 1 year
Questionnaire: Fatigue
Time Frame: through study completion, an average of 1 year
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
through study completion, an average of 1 year
Questionnaire: Physical Activity
Time Frame: through study completion, an average of 1 year
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).
through study completion, an average of 1 year
Questionnaire: Emotion Thermometers
Time Frame: through study completion, an average of 1 year
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
through study completion, an average of 1 year
Questionnaire: Brief Pain Inventory (BPI)
Time Frame: through study completion, an average of 1 year
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2018

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HRP-591-PEXO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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