Trial Information

The Use of Physical Activity to Control Fatigue and Improve the Quality of Life in Patients With Advanced Cancer Stage

Objectives:

1 - 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; 2.Assess the efficiency of physical activity upon QOL using EORTC QLQ-30; 3- To
test feasibility of standardized exercise in patients with advanced cancer and conduct
process evaluation including rates of recruitment and retention, attendance, satisfaction,
barriers; 4- To determine the change in ESAS symptom distress score before and after
treatment; 5 - Assess the efficiency of physical activity upon controlling the Anxiety and
Depression.

Methods and Materials

Outlining the study A clinical trial study will be performed.

Population and place of study The study will assess 30 patients diagnosed with cancer having
no chance of being healed and presenting fatigue ≥ 4 according to the ESAS, referred to by
the outpatient department of the palliative care and pain unit from Pius XII Foundation -
Barretos Cancer Hospital.

Methodology

After clarification and understanding of the research protocol and the consent in
participating under formal demands outlined on Resolution 196/96 of the National Health
Council/Brazil Health Ministry (1996) which provides about research involving human beings,
patients are submitted to 5 weekly sessions of a 10 continuous minutes walk during 4 weeks
in a 90-feet long corridor located at the palliative care unit and also a series of
exercises for the upper limbs with 1 lb-dumbbells. Patients' will have monitored their blood
pressure, heart/cardiac frequency ( 40-60% of HR RESERVE or 60-70% HR MAX) and oxygen
saturation by way of a finger oximeter made by Digit and perceived effort = light sweating,
increase HR and breathing. Dumbbell exercises during the first week will be 5 repetitions
each, which will increase 5 repetitions per week, reaching a total of 20 repetitions on the
last week. The exercises will be:

1. - shoulder flexion 0-180º;

2. - shoulder abduction and adduction;

3. - shoulder extension;

4. - elbow flexion;

5. - wrist flexion and extension;

Fatigue Evaluation Fatigue will be evaluated at the beginning ,in the end of the 2 weeks and
in end of the 4 weeks. by a person trained by the researcher with a FACIT-F (primary
outcomes) and ESAS FATIGUE. The FACIT-F questionnaire, which is subdivided in five
subscales: physical well-being, social/family well-being, emotional well-being, functional
well-being and additional worries. Each subscale is provided with questions that shall be
answered with a single number that would best describe the answer to that question. The
questionnaire Edmonton Symptom Assessment Score (ESAS) was originally prepared at the
General Hospital Edmonton (Canada) and published in 1991. This instrument consists of nine
symptoms: pain, fatigue, depression, anxiety, nausea, loss of appetite, well being and
dyspnea. Each symptom can have its intensity measured on a scale ranging from 0 (no symptom)
to 10 (the symptom in its strongest manifestation).

Anxiety and Depression Evaluation Anxiety and Depression will be evaluated at the beginning
, in the end of the 2 weeks and in end of the 4 weeks. by a person trained by the
researcher with a Anxiety & Depression Hospital Anxiety Depression scale(HADS). The HADS
contains 14 multiple-choice questions, divided into two subscales: anxiety and depression,
with seven items each. Each item has a score ranging from zero to three and overall range on
each subscale ranges from zero to 21. Higher values indicate more symptoms of anxiety and
depression20.

Quality of life Evaluation The quality of life of each patient will be evaluated at the
beginning , in the end of the 2 weeks and in end of the 4 weeks through an interview held by
a person trained by the researcher. In order to evaluate the quality of life of patients, an
instrument developed in 1986 by the European Organization for Research and Treatment of
Cancer (EORTC) will be used; this instrument is called QLQ-C30 and is available in three
versions.4 The EORTC QLQ-C30 version 3.0 validated for the Portuguese language presents 30
questions composed of both multi-item scales and single-item measures. These includes five
functional scales (physical, role, emotional, social, and cognitive), three symptom scales
(fatigue, pain and nausea and vomiting), and a global health status/QoL scale, and six
single items commonly reported by people with cancer (dyspnea, insomnia, appetite loss,
constipation, diarrhea and financial difficulties), an assessment scale of the financial
impact of the disease treatment.4 All of the scales and single-item measures range in score
from 0 to 100. A high scale score represents a higher response level. QLQ-C30 has been
designed so that all items in any scale take the same range of values. Most items are scored
1 to 4, giving range = 3. The exceptions will be the items that make up for the Global
Health Status/QoL, which scores vary from 1 to 7, with a numerical difference equal to 6.

Study Variables The following will be collected: clinical/demographic characteristics,
gender, age, skin color, marital status, level of schooling, diagnostic, onset of the
disease, treatment performed.

Statistical Analysis Patients will be characterized through a descriptive analysis, by way
of core tendency measures (mean and median) and dispersion (minimum and maximum standard
deviation, and 95% confidence interval). Tests will be used for repeat measures,
nonparametric data case, Wilcoxon test or parametric data, paired T-test. As statistical
significance, a value of p<0.05 will be considered.

The SPSS program version 17.0 for Windows will be used for tabulation and data analysis.

Ethical Considerations This project was approved by the Ethical Committee in Research of the
Pius XII Foundation - Barretos Cancer Hospital (Protocol 519/2011). Patients and witnesses,
after being informed about the treatment applied and clarified about the aim of the study,
will sign an informed consent. Thus, in this project, only the persons that signed the term
of consent will participate.