CancerAPQNCT02013921
Interest of Daily Physical Activity After Cancer Treatment
An observational study of Cancer and Tiredness, run by University Hospital, Limoges at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Physical activity
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Dec 2015
- Phase
- Observational
- 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
Study population: Patients with a breast cancer and are completing treatment
Who may be able to join
- 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
Who cannot join
- Patient with metastatic cancer.
- Patient for which monitoring required by the protocol is impossible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation du Niveau d'activité Physique Quotidien, Chez Des Patientes Porteuses d'un Cancer du Sein en période Post thérapeutique
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.
Read more
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.
- Being tested
- Physical activity
- Keywords
- Physical activity, Cancer
- Medical subject headings
- Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Patients with a breast cancer and are completing treatment Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013921
- Sponsor's protocol ID
- I12040
- Acronym
- APQ
- Status last verified
- Apr 2015
- First submitted
- 25 Nov 2013
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation du Niveau d'activité Physique Quotidien, Chez Des Patientes Porteuses d'un Cancer du Sein en période Post thérapeutique
- ClinicalTrials.gov ID
- NCT02013921
- Acronym / sponsor ID
- APQ / I12040
- Keywords
- Physical activity, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | – | Other: Physical activityPatients with a breast cancer and are completing treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a breast cancer and are completing treatment
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient with metastatic cancer.
- Patient for which monitoring required by the protocol is impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity | Other | Physical Activity |
Primary outcome
Daily physical activity assessment at 3 months
Time frame: Month 3
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Tiredness, run by University Hospital, Limoges at 1 site in France.
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 5 inclusion and 2 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 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Daily physical activity assessment at 3 months (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2019.