Breakthrough Pain
Conditions
Keywords
Breakthrough Cancer Pain, Quality of life, Radiotherapy
Brief summary
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Angelini Farmacéutica
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 18 years * Cancer Patients * Patients attended in radiation oncology consultations with palliative intent * Life expectancy \> 6 months * Written informed consent * Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm
Exclusion criteria
* Untreated patients with opioids for baseline pain * Patients who are not opioid tolerant * Serious psychiatric disorder or any disease or condition that prevents the collection of data * Patients with evidence of opioid addiction or history of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life according SF-12 questionnaire | Baseline and 4-6 weeks (estimated end of radiotherapy treatment) | Change in punctuation of the SF-12 questionnaire between end of radiotherapy treatment and baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comorbidities associated with patients | Baseline (the day that patient sign the informed consent form) | Percentage of patients with each comorbidity |
| Mean time to relief of breakthrough pain | Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment | Time from the start of the episode until the relief of breakthrough pain |
| Mean duration of the episodes of breakthrough pain | Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment | Time from the start of the episode until the pain ends |
| Clinical Global improvement | 4-6 weeks (estimated end of radiotherapy treatment) | Number of patients indicating each of the possible answers of the Clinical Global Impression of improvement scale |
| Percentage of patients with neuropathic, visceral, somatic and mixed pain | Baseline (the day that patient sign the informed consent form) | Percentage of patients with neuropathic, visceral, somatic and mixed pain |
| Change in assessment (percentage) of family claudication | Baseline and 4-6 weeks (estimated end of radiotherapy treatment) | Difference in percentage of patients with punctuation ≥ 17 points at end of radiotherapy treatment and baseline. |
| Change in mean Intensity of breakthrough cancer pain at each study visit | Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment | Intensity of breakthrough cancer pain assessed with a Visual Analog Scale (VAS). VAS will be compared at each study visit. |
| Change in MOS Sleep Scale scores | Baseline and 4-6 weeks (estimated end of radiotherapy treatment) | Change in MOS Sleep Scale scores between end of radiotherapy treatment and baseline |
| Patient Global improvement | 4-6 weeks (estimated end of radiotherapy treatment) | Number of patients indicating each of the possible answers of the Patient Global Impression of improvement scale |
Countries
Spain
Outcome results
None listed