In the context of radiotherapy, control of breakthrough pain represents a special challenge. Patients undergoing radiotherapy may experience different situations of pain that may be due to the need to remain immobilized during radiotherapy session, the need to wear an immobilization mask (head and neck cancer), the odynophagia caused by mucositis, defecation after the development of proctitis, or sudden pain during the night causing sleep disturbances. In a survey conducted in radiation oncology services more than half of patients treated with radiotherapy experienced pain, and 39% of patients reported that their pain was not treated properly. This situation may increase the patient's anxiety, dissatisfaction with treatment, affect their quality of life and can even come to refuse radiotherapy treatment. This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in radiotherapy services in Spanish hospitals.
Study Type
OBSERVATIONAL
Enrollment
79
No intervention
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital de Terrassa
Terrassa, Barcelona, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Do Meixoeiro
Vigo, Pontevedra, Spain
Centro Oncológico de galicia
A Coruña, Spain
Hospital de l'Esperança
Barcelona, Spain
ICO Hospitalet
Barcelona, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Regional de Málaga
Málaga, Spain
...and 1 more locations
Change in quality of life according SF-12 questionnaire
Change in punctuation of the SF-12 questionnaire between end of radiotherapy treatment and baseline.
Time frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Percentage of patients with neuropathic, visceral, somatic and mixed pain
Percentage of patients with neuropathic, visceral, somatic and mixed pain
Time frame: Baseline (the day that patient sign the informed consent form)
Comorbidities associated with patients
Percentage of patients with each comorbidity
Time frame: Baseline (the day that patient sign the informed consent form)
Mean time to relief of breakthrough pain
Time from the start of the episode until the relief of breakthrough pain
Time frame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
Mean duration of the episodes of breakthrough pain
Time from the start of the episode until the pain ends
Time frame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
Clinical Global improvement
Number of patients indicating each of the possible answers of the Clinical Global Impression of improvement scale
Time frame: 4-6 weeks (estimated end of radiotherapy treatment)
Patient Global improvement
Number of patients indicating each of the possible answers of the Patient Global Impression of improvement scale
Time frame: 4-6 weeks (estimated end of radiotherapy treatment)
Change in assessment (percentage) of family claudication
Difference in percentage of patients with punctuation ≥ 17 points at end of radiotherapy treatment and baseline.
Time frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Change in mean Intensity of breakthrough cancer pain at each study visit
Intensity of breakthrough cancer pain assessed with a Visual Analog Scale (VAS). VAS will be compared at each study visit.
Time frame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
Change in MOS Sleep Scale scores
Change in MOS Sleep Scale scores between end of radiotherapy treatment and baseline
Time frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
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