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Active, Not Recruiting

NCT Number: NCT04328038

Personalized Exercise Oncology

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Behavior Health Behavior Motor Activity Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heidelberg University Hospital

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

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

Primary outcomes

  1. Patient Clusters

    Time frame: through study completion, an average of 1 year

    Identification of different, trait-homogenous patient clusters

Secondary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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

  5. 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).

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Penn State University

Registry information

Official study title

Personalized Exercise Oncology (PEXO) - Study

Acronym: PEXO

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Mar 31, 2020
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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