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MOTIVACTION - Study

This study is currently recruiting participants.
Verified April 2012 by German Cancer Research Center
Sponsor:
Collaborator:
University of Heidelberg
Information provided by (Responsible Party):
German Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01576107
First received: April 5, 2012
Last updated: April 13, 2012
Last verified: April 2012
History of Changes
  Purpose

Impact of a 4-week exercise intervention vs. a stress-management-training on physical activity (measured objectively and by questionnaire) of cancer patients of different entities and out-patient regimes.


Condition Intervention
Cancer
 Other: Exercise counseling (behavior change techniques)
Other: Stress-management training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Motivational Intervention Enhancing Physical Activity In Oncology Patients (MOTIVACTION)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • Physical activity (accelerometer, Actigraph) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    measured for 7 days


Secondary Outcome Measures:
  • physical activity (Short QUestionnaire to ASsess Healthenhancing physical activity, SQUASH) [ Time Frame: 4 weeks, 3 months ] [ Designated as safety issue: No ]
    Wendel-Vos, G.C.W. et al., 2003

  • Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G) [ Time Frame: 4 weeks, 3 months ] [ Designated as safety issue: No ]
    German version by Freud, T. (2011)

  • Quality of life (EORTC QLQ C30) [ Time Frame: 4 weeks, 3 months ] [ Designated as safety issue: No ]
    Aaronson, N. K. et al. (1993)

  • variables of the Health Action Process Approach [ Time Frame: 4 weeks, 3 months ] [ Designated as safety issue: No ]
    scales are developed according to the guidelines by the founder of the theory (Schwarzer, 2008)

  • Barriers and barrier management in physical exercise [ Time Frame: 4 weeks, 3 months ] [ Designated as safety issue: No ]
    adapted from Krämer&Fuchs (2010), developed in pilot studies

  • Exercise experience [ Time Frame: 4 weeks, 3 Months ] [ Designated as safety issue: No ]
    questionnaire adapted from Fuchs, R., 2009


Estimated Enrollment: 80
Study Start Date: April 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical activity
Exercise counseling (behavior change techniques)
 Other: Exercise counseling (behavior change techniques)
4-week exercise intervention for cancer patients of different entities and out-patient regimes.
Experimental: Stress-management
Stress-management training
 Other: Stress-management training
4-week stress-management-training for cancer patients of different entities and out-patient regimes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physical activity < 150 minutes /week
  • Patients are currently receiving outpatient treatment (acute or maintenance therapy) or finished this therapy not longer than six months ago

Exclusion Criteria:

  • Serious Orthopedic limitations
  • Serious neurological disorders
  • Serious cardiovascular diseases
  • Bone metastases
  • wound healing / scarring not completed
  • Rehabilitation during the next eight weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576107

Contacts
Contact: Nadine Ungar +49 6221 56 35691 Nadine.Ungar@nct-heidelberg.de

Locations
Germany
National Center for Tumor Diseases (German Cancer Research Center) Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
National Center for Tumor Diseases Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Nadine Ungar     +49 6221 5635691     nadine.ungar@nct-heidelberg.de    
Sponsors and Collaborators
German Cancer Research Center
University of Heidelberg
Investigators
Principal Investigator: Joachim Wiskemann, Dr. German Cancer Research Center
  More Information

No publications provided

Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01576107     History of Changes
Other Study ID Numbers: NCT-PA8
Study First Received: April 5, 2012
Last Updated: April 13, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by German Cancer Research Center:
Different cancer entities

ClinicalTrials.gov processed this record on May 16, 2013