Fatigue, Neoplasms
Conditions
Keywords
Cancer survivors, training, exercise, cancer-related fatigue
Brief summary
Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus a supervised resistance program. The primary objective is improvement of cancer-related fatigue.
Detailed description
Patients should have finalized their oncological treatment in the previous 5 years. The sample size (32 patients) was calculated to improve the perception of fatigue score from an anticipated initial 38 to a post-intervention 48. The control arm consist of supervised strength training in two sessions per week with non-supervised international recommendations for aerobic exercise. The experimental arm will consist of supervised strength + resistance training in two sessions per week. After evaluating the weekly physical activity through accelerometer, body composition through DEXA and the cardiorespiratory fitness through CPET, participants will initiate the training according to a randomized assignment. Secondary objectives include: 1. cardiorespiratory fitness, 2. quality of life; 3. adherence to the training program; 4. adherence to international recommendations, 5. body composition, 6. employment status
Interventions
BEHAVIORALVigorous aerobic training
Supervised vigorous aerobic training
Sponsors
Universidad Europea de Madrid
Puerta de Hierro University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 * history of breast or colon cancer * no evidence of disease * end of treatment in the last five years * able to understand the questionnaire PERFORM * able to manage the accelerometer
Exclusion criteria
* mobility limitation * treatment with beta-blockers *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in cancer related-fatigue | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in quality of life | 4 months | measured through EORTC QLQ C30 |
| adherence to the program | 4 months | — |
| Changes in cardiorespiratory fitness | 4 months | measured through CPET |
| Changes in body composition | 4 months | measured by DEXA (Dual Energy X-Ray Absortiometry) |
| Employment status | 4 months | — |
| adherence to international recommendations | 4 months | measured by accelerometer |
Countries
Spain
Outcome results
None listed