Adapted Physical Activity and CancerUMACHAPANCT03049436
Adapted Physical Activity in a Chemotherapy Ambulatory Care Unit: Feasibility and Impact on Fatigue, Anxiety and Depression in Cancer Patients
An observational study of Adapted Physical Activity and Cancer, run by CHU de Reims at 1 site in France.
Trial summary
Physical activity has demonstrated efficacy in cancer prevention and improves quality of life and outcome in cancer survivors. Patients undergoing chemotherapy, especially those with advanced disease, may have symptoms leading to inactivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adapted Physical Activity and Cancer
- What is being tested?
- Program of adapted physical activity
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2017to 1 Feb 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: Patients undergoing chemotherapy or targeted therapy at UMA-CH ambulatory care service of Reims, CHU, for a digestive, lung, hematological or dermatological cancers, of any stage, between February 2017 and August 2017
Who may be able to join
- Patients beginning chemotherapy or targeted therapy at UMA-CH ambulatory care unit of Reims, CHU, for a digestive, lung, hematological or dermatological cancer, of any stage
- Patients who agree to participate to the study
- Major patient
Who cannot join
- Patient with previous chemotherapy or targeted therapy in the UMA-CH unit
- Patient under law protection
- Minor patient
- Patient with neurological defect preventing from any physical activity
Trial locations and contacts
1 site in 1 country.
Olivier BOUCHE contact
France1 site, 1 recruiting
- Recruiting
Chu de Reims
Reims, France, 51092
Olivier BOUCHE, obouche@chu-reims.fr
About this study
Physical activity has demonstrated efficacy in cancer prevention and improves quality of life and outcome in cancer survivors. Patients undergoing chemotherapy, especially those with advanced disease, may have symptoms leading to inactivity. Adapted physical activity (APA) among those patients could improve their tolerance to the treatment, and thereby their quality of life. APA could be beneficial to patients with curable disease as well as patients undergoing palliative chemotherapy. Some studies suggest that fighting against loss of muscle mass could lead to a survival benefit. However, APA is not established in daily practice and has not yet been evaluated in a chemotherapy ambulatory care unit.
Primary aim of the study is to assess feasibility of an APA program in a chemotherapy ambulatory care unit of digestive, lung, hematological and dermatological cancers Secondary aim is to measure the impact of an APA program on fatigue, anxiety, depression and handgrip strength in patients beginning chemotherapy or targeted therapy for a digestive, lung, hematological or dermatological cancer, of any stage.
Read the detailed description
Assess feasibility of an APA program in a chemotherapy ambulatory care unit of digestive, lung, hematological, and dermatological cancers Measure the impact of an APA program on fatigue, anxiety, depression, handgrip strength
- Conditions
- Adapted Physical Activity and Cancer
- Being tested
- Program of adapted physical activity
- Keywords
- Physical activity, cancer, chemotherapy, daily care unit
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program of adapted physical activityOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with program of adapted physical activity | Not described Receives: Other: Program of adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of APA program
Percentage of patients accepting APA program
Measured: Day 0
Secondary outcomes (6)
fatigue
Fatigue evaluating using the Multidimensional Fatigue Inventory. The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument assessing the following items: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. It has been validated to assess fatigue in cancer patients.
Measured: Month 3
Anxiety
Anxiety evaluating using Hospital Anxiety and Depression scale. Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression, in a two factors model, without confounding with somatic or psychiatric disorders, and has been validated in cancer patients.
Measured: Month 3
Fatigue
Fatigue evaluating using the Multidimensional Fatigue Inventory. The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument assessing the following items: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.
Measured: Month 6
Anxiety
Anxiety evaluating using Hospital Anxiety and Depression scale. Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression, in a two factors model, without confounding with somatic or psychiatric disorders, and has been validated in cancer patients.
Measured: Month 6
handgrip strength
handgrip strength evaluating using Hand grip test. Hand grip test allows the measurement of muscle strength of the upper limbs, which is a reflection of the overall strength of an individual. Thresholds for the loss of muscle strength are <17kg in women and <30 kg in men.
Measured: Month 3
handgrip strength
handgrip strength evaluating using Hand grip test. Hand grip test allows the measurement of muscle strength of the upper limbs, which is a reflection of the overall strength of an individual. Thresholds for the loss of muscle strength are <17kg in women and <30 kg in men.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start1 Feb 2017
- Primary completion1 Feb 2018 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adapted Physical Activity and CancerStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049436
- Sponsor's protocol ID
- PZ17008
- Acronym
- UMACHAPA
- Status last verified
- Jan 2017
- First submitted
- 8 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Physical Activity in a Chemotherapy Ambulatory Care Unit: Feasibility and Impact on Fatigue, Anxiety and Depression in Cancer Patients
- ClinicalTrials.gov ID
- NCT03049436
- Acronym / sponsor ID
- UMACHAPA / PZ17008
- Conditions
- Adapted Physical Activity and Cancer
- Keywords
- Physical activity, cancer, chemotherapy, daily care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 10 Feb 2017 (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.
Physical activity has demonstrated efficacy in cancer prevention and improves quality of life and outcome in cancer survivors. Patients undergoing chemotherapy, especially those with advanced disease, may have symptoms leading to inactivity. Adapted physical activity (APA) among those patients could improve their tolerance to the treatment, and thereby their quality of life. APA could be beneficial to patients with curable disease as well as patients undergoing palliative chemotherapy. Some studies suggest that fighting against loss of muscle mass could lead to a survival benefit. However, APA is not established in daily practice and has not yet been evaluated in a chemotherapy ambulatory care unit.
Primary aim of the study is to assess feasibility of an APA program in a chemotherapy ambulatory care unit of digestive, lung, hematological and dermatological cancers Secondary aim is to measure the impact of an APA program on fatigue, anxiety, depression and handgrip strength in patients beginning chemotherapy or targeted therapy for a digestive, lung, hematological or dermatological cancer, of any stage.
Detailed description
Assess feasibility of an APA program in a chemotherapy ambulatory care unit of digestive, lung, hematological, and dermatological cancers Measure the impact of an APA program on fatigue, anxiety, depression, handgrip strength
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with program of adapted physical activity | – | Other: Program of adapted physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing chemotherapy or targeted therapy at UMA-CH ambulatory care service of Reims, CHU, for a digestive, lung, hematological or dermatological cancers, of any stage, between February 2017 and August 2017
Key inclusion criteria (3 listed)
- Patients beginning chemotherapy or targeted therapy at UMA-CH ambulatory care unit of Reims, CHU, for a digestive, lung, hematological or dermatological cancer, of any stage
- Patients who agree to participate to the study
- Major patient
Key exclusion criteria (4 listed)
- Patient with previous chemotherapy or targeted therapy in the UMA-CH unit
- Patient under law protection
- Minor patient
- Patient with neurological defect preventing from any physical activity
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 |
|---|---|---|
| Program of adapted physical activity | Other | Patients with program of adapted physical activity |
Primary outcome
Feasibility of APA program
Time frame: Day 0
Percentage of patients accepting APA program
6 secondary outcomes
fatigue
Time frame: Month 3
Anxiety
Time frame: Month 3
Fatigue
Time frame: Month 6
Anxiety
Time frame: Month 6
handgrip strength
Time frame: Month 3
handgrip strength
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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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.
Olivier BOUCHE contact
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 Adapted Physical Activity and Cancer, run by CHU de Reims 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier BOUCHE (obouche@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of APA program (time frame: Day 0). 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 10 Feb 2017.