Personalized Exercise Oncology

Cancer Clinical Trial

— PEXO  

Official title:

Personalized Exercise Oncology (PEXO) - Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04328038
• Other study ID #: HRP-591-PEXO
• Status: Active, not recruiting
• Start date: November 26, 2018
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Health Behavior

Intervention

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

Locations

Country	Name	City	State
Germany	Heidelberg University Hospital	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Penn State University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Clusters	Identification of different, trait-homogenous patient clusters	through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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