NCT04328038

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

7 years

First QC Date

March 24, 2020

Last Update Submit

January 30, 2025

Conditions

CancerHealth Behavior

Keywords

Physical ActivityExerciseHealth literacycancer-related symptomstreatment-related symptomspersonalized Medicine

Outcome Measures

Primary Outcomes (1)

  • Patient Clusters

    Identification of different, trait-homogenous patient clusters

    through study completion, an average of 1 year

Secondary Outcomes (7)

  • Questionnaire: Physical Activity Associated Health Literacy

    through study completion, an average of 1 year

  • Questionnaire: Health Literacy

    through study completion, an average of 1 year

  • Questionnaire: Health Related Quality of Life

    through study completion, an average of 1 year

  • Questionnaire: Fatigue

    through study completion, an average of 1 year

  • Questionnaire: Physical Activity

    through study completion, an average of 1 year

  • +2 more secondary outcomes

Study Arms (2)

USA

Cohort from the USA

Other: Survey

Germany

Cohort from Germany

Other: Survey

Interventions

SurveyOTHER

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

GermanyUSA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mixed Cohort of adult cancer patients undergoing treatment Special Subgroup: Multiple Myeloma Patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heidelberg University Hospital

Heidelberg, 69120, Germany

Location

Related Publications (2)

  • Greinacher A, Kuehl R, Mai EK, Goldschmidt H, Wiskemann J, Fleischer A, Rasche L, Dapunt U, Maatouk I. The impact of divergent forms of social support on health-related quality of life in patients with multiple myeloma and its precursor states. J Cancer Res Clin Oncol. 2024 Jan 31;150(2):55. doi: 10.1007/s00432-023-05570-9.

    PMID: 38291214DERIVED

  • Kuehl R, Koeppel M, Goldschmidt H, Maatouk I, Rosenberger F, Wiskemann J. Physical activity-related health competence and symptom burden for exercise prescription in patients with multiple myeloma: a latent profile analysis. Ann Hematol. 2023 Nov;102(11):3091-3102. doi: 10.1007/s00277-023-05326-y. Epub 2023 Jun 24.

    PMID: 37355476DERIVED

MeSH Terms

Conditions

NeoplasmsHealth BehaviorMotor Activity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Exercise Onoclogy, Principal Investigator, Associated Professor

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 31, 2020

Study Start

November 26, 2018

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations

DE(1)