Fatigue Before and After Exercise in Patients With Advanced Cancer Stage
Objectives: Assess the efficiency of physical activity upon controlling the fatigue and quality of life in patients with advanced stage of the disease at the end of 4 weeks using FACIT-F subscale, and test the feasibility of standardized exercise in patients with advanced cancer and conduct process evaluation including rates of recruitment and retention, attendance, satisfaction, barriers. Methods: This study will be a clinical trial and, provided the study informed consent has been signed, will count with the participation of 30 patients, from the Barretos Cancer Hospital Palliative Care unit, presenting fatigue ≥ 4 according to the of Edmonton Symptom Assessment Score (ESAS). All patients will undergo a 10-minute walk and exercises for the upper limbs with 1 lb-dumbbells, increasing the number of repetitions weekly, attending 5 sessions a week, during 4 weeks. A quality of life questionnaire, EORTC QLQ-30, FACIT-F, ESAS and Anxiety & Depression Hospital Anxiety Depression scale(HADS), will be filled out at the beginning, in the end of the 2 weeks and in end of the 4 weeks.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of Physical Activity to Control Fatigue and Improve the Quality of Life in Patients With Advanced Cancer Stage|
- Fatigue [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Fatigue will be assessed by means of ESAS score and FACT-F questionnaire. The outcome will be measured 1 day before starting the intervention (exercises and walking), 2 weeks and 4 weeks after starting the intervention.
- Quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Quality of life will be assessed by means of EORTC-QLQ-C30. This instrument produces a score (quantitative variable). Quality of life will be measured 1 day before starting the intervention, 2 weeks and 4 weeks after starting the intervention.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Single arm
10-minute walk and exercises for the upper limbs with 1 lb-dumbbells
Other: 10-minute walk and exercises
All patients will undergo a 10-minute walk and exercises for the upper limbs with 1 lb-dumbbells, increasing the number of repetitions weekly, attending 5 sessions a week, during 4 weeks.
Other Name: 10-minute walk and exercises
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|Contact: Adriana S Ferreira, PhD||+55 17-3321-6600 ext firstname.lastname@example.org|
|São Judas Tadeu Hospital||Recruiting|
|Barretos, SP, Brazil, 14784400|
|Contact: Adriana S Ferreira, PhD +55-17-3321-6600 ext 5528 email@example.com|
|Principal Investigator: Adriana S Ferreira, PhD|
|Principal Investigator:||Adriana M Ferreira, PhD||Barretos Cancer Hospital|