MOTIVACTION - Study

This study has been completed.
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
German Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01576107
First received: April 5, 2012
Last updated: April 22, 2014
Last verified: April 2014
  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:


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


Enrollment: 76
Study Start Date: April 2012
Study Completion Date: May 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576107

Locations
Germany
National Center for Tumor Diseases (German Cancer Research Center)
Heidelberg, Baden-Württemberg, Germany, 69120
National Center for Tumor Diseases
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
German Cancer Research Center
Heidelberg University
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 22, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by German Cancer Research Center:
Different cancer entities

ClinicalTrials.gov processed this record on July 24, 2014