Adapted Physical Activity in a Chemotherapy Ambulatory Care Unit: Feasibility and Impact on Fatigue, Anxiety and Depression in Cancer Patients

• Conditions: Adapted Physical Activity and Cancer
• Interventions: Other: Program of adapted physical activity

• Registration Number: NCT03049436
• Lead Sponsor: CHU de Reims

Brief 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. 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 Timeline

• Status Verified: 2017-01
• Study Start: 2017-02-01
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-08
• Last Update Submitted: 2017-02-08
• Study First Posted: 2017-02-10
• Last Update Posted: 2017-02-10
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with program of adapted physical activity	Program of adapted physical activity	-

Primary Outcome Measures

Name	Time	Method
Feasibility of APA program	Day 0	Percentage of patients accepting APA program

Secondary Outcome Measures

Name	Time	Method
fatigue	Month 3	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.
Anxiety	Month 6	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.
Fatigue	Month 6	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.
handgrip strength	Month 6	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.

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France