Personalized Exercise Oncology

Study Overview
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Brief Summary
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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.

Official Title
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Personalized Exercise Oncology (PEXO) - Study

Conditions
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Cancer, Health Behavior

Intervention / Treatment
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* Other: Survey


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Exercise, Health literacy, cancer-related symptoms, treatment-related symptoms, personalized Medicine