PEXO: Personalized Exercise Oncology

Sponsor

University Hospital Heidelberg (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04328038

Collaborator

Penn State University (Other)

800

Enrollment

Location

58.2

Anticipated Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Health Behavior	Other: Survey

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Personalized Exercise Oncology (PEXO) - Study

Actual Study Start Date :

Nov 26, 2018

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Patient Clusters [through study completion, an average of 1 year]
Identification of different, trait-homogenous patient clusters

Secondary Outcome Measures

Questionnaire: Physical Activity Associated Health Literacy [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
Questionnaire: Health Literacy [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
Questionnaire: Health Related Quality of Life [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).
Questionnaire: Fatigue [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
Questionnaire: Physical Activity [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).
Questionnaire: Emotion Thermometers [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
Questionnaire: Brief Pain Inventory (BPI) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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