Adapted Physical Activity and Cancer Clinical Trial
— UMACHAPAOfficial title:
Adapted Physical Activity in a Chemotherapy Ambulatory Care Unit: Feasibility and Impact on Fatigue, Anxiety and Depression in Cancer Patients
| Verified date | January 2017 |
| Source | CHU de Reims |
| Contact | Olivier BOUCHE |
| obouche[@]chu-reims.fr | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 250 |
| Est. completion date | February 1, 2018 |
| Est. primary completion date | February 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu de Reims | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Feasibility of APA program | Percentage of patients accepting APA program | Day 0 | |
| Secondary | 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. | Month 3 | |
| Secondary | 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. | Month 3 | |
| Secondary | 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. | Month 6 | |
| Secondary | 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. | Month 6 | |
| Secondary | 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. | Month 3 | |
| Secondary | 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. | Month 6 |