Cancer, Treatment-RelatedPODOMETRENCT03961451
Number of Weekly Steps, Fatigue, Quality of Life, Well-being During Cancer Treatment: Impact of Recommendations Strengthened by the Provision of Web Interface and Tele-coaching.
An observational study of Cancer, Treatment-Related, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
study to correlate this level of objective physical activity with the levels of fatigue and quality of life in cancer patient being treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Treatment-Related
- What is being tested?
- Podometer
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 19 Apr 2018
- 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: All cancer pathologies, all treatments. Provided that the patient is fit for walking.
Who may be able to join
- Patients being treated, Medical Day Hospital / HAD
Who cannot join
- Inability to walk declared by an site medical doctor
Trial locations and contacts
1 site in 1 country.
About this study
study to correlate this level of objective physical activity with the levels of fatigue and quality of life in cancer patient being treated.
Read the detailed description
Study to objectify the level of physical activity of patients by a tool, often used in the global population: the pedometer. Several measurements per questionnaire also will be carried out repeatedly (weekly) in order to correlate this level of objective physical activity with the levels of fatigue and quality of life. The hypothesis we formulate is as follows: the number of weekly steps is negatively correlated with the level of fatigue, positively with the quality of life and well-being.
- Conditions
- Cancer, Treatment-Related
- Being tested
- Podometer
- Keywords
- pedometer
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PodometerDevice
Patients will be equipped with pedometers for 8 weeks, all day and must complete the number of steps each day. They will have to complete online evaluation questionnaires regularly. The main objective is to correlate the level of physical activity with the level of fatigue, quality of life and well-being weekly during an anticancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group With Recommendations (GAR) | Patients in the GAR group will receive several recommendations and will have access to an online tool to increase motivation to engage in physical activity. Receives: Device: Podometer | |
| Control Group (GC) | No recommendation given Receives: Device: Podometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life satisfaction
Satisfaction With Life Scale (Blais et al, 1989, french-canadian validation, Revue Canadienne des Sciences du Comportement, 21(2), 210-223.)
Measured: 2 months
Positive and negative affects measurement
Positive and Negative Affect Schedule (PANAS scales) (Caci et Baylé, 2007 First traduction in French, Congrès de l'Encéphale, Paris, 25-27 january 2007)
Measured: 2 months
Fatigue
Multidimensional Inventory Fatigue : Gentile et al, 2003, Validation of the French multidimensional fatigue inventory (MFI 20), Eur J Cancer Care)
Measured: 2 months
Quality of Life
European Organisation for Research and Treatment of Cancer Questionnaire Quality of Life version 30
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion19 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, Treatment-RelatedStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Cappiello, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961451
- Sponsor's protocol ID
- PODOMETRE-IPC 2015-028
- Acronym
- PODOMETRE
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villaron C, Cury F, Eisinger F, Cappiello MA, Marqueste T. Telehealth applied to physical activity during cancer treatment: a feasibility, acceptability, and randomized pilot study. Support Care Cancer. 2018 Oct;26(10):3413-3421. doi: 10.1007/s00520-018-4191-4. Epub 2018 Apr 19.
PubMed 29675546
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Number of Weekly Steps, Fatigue, Quality of Life, Well-being During Cancer Treatment: Impact of Recommendations Strengthened by the Provision of Web Interface and Tele-coaching.
- ClinicalTrials.gov ID
- NCT03961451
- Acronym / sponsor ID
- PODOMETRE / PODOMETRE-IPC 2015-028
- Conditions
- Cancer, Treatment-Related
- Keywords
- pedometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 23 May 2019 (actual)
- 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.
study to correlate this level of objective physical activity with the levels of fatigue and quality of life in cancer patient being treated.
Detailed description
Study to objectify the level of physical activity of patients by a tool, often used in the global population: the pedometer. Several measurements per questionnaire also will be carried out repeatedly (weekly) in order to correlate this level of objective physical activity with the levels of fatigue and quality of life. The hypothesis we formulate is as follows: the number of weekly steps is negatively correlated with the level of fatigue, positively with the quality of life and well-being.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group With Recommendations (GAR) | – | Device: PodometerPatients in the GAR group will receive several recommendations and will have access to an online tool to increase motivation to engage in physical activity. |
| Control Group (GC) | – | Device: PodometerNo recommendation given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cancer pathologies, all treatments. Provided that the patient is fit for walking.
Key inclusion criteria (1 listed)
- Patients being treated, Medical Day Hospital / HAD
Key exclusion criteria (1 listed)
- Inability to walk declared by an site medical doctor
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 |
|---|---|---|
| PodometerPatients will be equipped with pedometers for 8 weeks, all day and must complete the number of steps each day. They will have to complete online evaluation questionnaires regularly. The main objective is to correlate the level of physical activity with the level of fatigue, quality of life and well-being weekly during an anticancer treatment. | Device | Control Group (GC), Group With Recommendations (GAR) |
Primary outcome
Life satisfaction
Time frame: 2 months
Satisfaction With Life Scale (Blais et al, 1989, french-canadian validation, Revue Canadienne des Sciences du Comportement, 21(2), 210-223.)
Positive and negative affects measurement
Time frame: 2 months
Positive and Negative Affect Schedule (PANAS scales) (Caci et Baylé, 2007 First traduction in French, Congrès de l'Encéphale, Paris, 25-27 january 2007)
Fatigue
Time frame: 2 months
Multidimensional Inventory Fatigue : Gentile et al, 2003, Validation of the French multidimensional fatigue inventory (MFI 20), Eur J Cancer Care)
Quality of Life
Time frame: 2 months
European Organisation for Research and Treatment of Cancer Questionnaire Quality of Life version 30
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 23 May 2019.
- Results publication: PubMed 29675546Villaron C, Cury F, Eisinger F, Cappiello MA, Marqueste T. Telehealth applied to physical activity during cancer treatment: a feasibility, acceptability, and randomized pilot study. Support Care Cancer. 2018 Oct;26(10):3413-3421. doi: 10.1007/s00520-018-4191-4. Epub 2018 Apr 19.
- Individual participant dataSharing planned: No
Related trials for Cancer, Treatment-Related
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
Active, not recruiting
Predictive Markers of Immune-related Adverse Events in Patients Treated With Immune Stimulatory Drugs
Cancer
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
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.
Maria Cappiello, MD principal investigator
Institut Paoli-Calmettes
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, Treatment-Related, run by Institut Paoli-Calmettes 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 1 inclusion and 1 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 May 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?
Life satisfaction (time frame: 2 months). The study lists 4 primary outcomes in all. 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 NCT03961451, 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 May 2019.