Personalized Exercise Oncology (PEXO)

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: Cancer; Health Behavior
• Intervention / Treatment: Other: Survey

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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	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	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	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	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	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	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)	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

• Sponsor: University Hospital Heidelberg
• Collaborators: Penn State University

Study record dates

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