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CancerNCT01576107

MOTIVACTION - Study

A study testing Exercise counseling (behavior change techniques) and Stress-management training in people with Cancer, run by German Cancer Research Center at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Exercise counseling (behavior change techniques) and Stress-management training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesGermany
Study dates
Apr 2012to May 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Serious Orthopedic limitations
  • Serious neurological disorders
  • Serious cardiovascular diseases
  • Bone metastases
  • wound healing / scarring not completed
  • Rehabilitation during the next eight weeks

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • National Center for Tumor Diseases (German Cancer Research Center)

    Heidelberg, Baden-Wurttemberg, 69120

  • National Center for Tumor Diseases

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

About this study

Official title: Motivational Intervention Enhancing Physical Activity In Oncology Patients (MOTIVACTION)

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.

Conditions
Cancer
Being tested
Exercise counseling (behavior change techniques), Stress-management training
Keywords
Different cancer entities
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise counseling (behavior change techniques)Other

    4-week exercise intervention for cancer patients of different entities and out-patient regimes.

  • Stress-management trainingOther

    4-week stress-management-training for cancer patients of different entities and out-patient regimes.

Study groups in NCT01576107
Study groupRoleWhat they receive
Physical activityExperimentalExercise counseling (behavior change techniques)
Receives: Other: Exercise counseling (behavior change techniques)
Stress-managementExperimentalStress-management training
Receives: Other: Stress-management training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical activity (accelerometer, Actigraph)

    measured for 7 days

    Measured: 4 weeks

Secondary outcomes (6)

  1. physical activity (Short QUestionnaire to ASsess Healthenhancing physical activity, SQUASH)

    Wendel-Vos, G.C.W. et al., 2003

    Measured: 4 weeks, 3 months

  2. Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G)

    German version by Freud, T. (2011)

    Measured: 4 weeks, 3 months

  3. Quality of life (EORTC QLQ C30)

    Aaronson, N. K. et al. (1993)

    Measured: 4 weeks, 3 months

  4. variables of the Health Action Process Approach

    scales are developed according to the guidelines by the founder of the theory (Schwarzer, 2008)

    Measured: 4 weeks, 3 months

  5. Barriers and barrier management in physical exercise

    adapted from Krämer\&Fuchs (2010), developed in pilot studies

    Measured: 4 weeks, 3 months

  6. Exercise experience

    questionnaire adapted from Fuchs, R., 2009

    Measured: 4 weeks, 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionNov 2012
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01576107
Sponsor's protocol ID
NCT-PA8
Status last verified
Apr 2014
First submitted
5 Apr 2012
Last updated
23 Apr 2014
Results posted
No

Publications

  • Ungar N, Wiskemann J, Sieverding M. Physical Activity Enjoyment and Self-Efficacy As Predictors of Cancer Patients' Physical Activity Level. Front Psychol. 2016 Jun 21;7:898. doi: 10.3389/fpsyg.2016.00898. eCollection 2016.

    PubMed 27445882

Questions about this trial

What is this clinical trial studying?

A study testing Exercise counseling (behavior change techniques) and Stress-management training in people with Cancer, run by German Cancer Research Center at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity (accelerometer, Actigraph) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01576107, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.

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