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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02013921
Other study ID # I12040
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2013
Est. completion date December 2015

Study information

Verified date April 2015
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Many studies have demonstrated the beneficial effects of Adapted Physical Activity (APA) in different cancer types.

It therefore seems necessary to assess spontaneous Physical Activity in order to integrate it to the overall calculation of physical activity in clinical practice.

To assess the AP, two types of methods are validated : the subjective method using a questionnaries and objective method using a pedometer , accelerometer or measures calorimetry .

Subjective method shows , good acceptability by patients and low cost but can sometimes lead to poor estimation of the level of activity.

Objective methods obviously increase the accuracy of assessments but are more difficult to use for epidemiological studies , less accepted by the patient and more expensive.

In this study the investigators will measure the spontaneous Daily Physical Activity by both methods andd evaluate the correclation.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult (age = 18 years)

- Having been informed of the study orally and in writing and have not expressed opposition to his participation

- Performance status <2

- Invasive breast adenocarcinoma, histologically documented.

- Patients with a breast cancer and are completing treatment

- Exclusion Criteria:

- Patient with metastatic cancer.

- Patient for which monitoring required by the protocol is impossible.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical activity


Locations

Country Name City State
France Oncologie- CHU Limoges Limoges

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily physical activity assessment at 3 months Physical activity is measured by means of an Actigraph. Patients will measure their daily physical activity , three times during one week espaced by 1 month. Month 3
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