Quality of Life Study Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent
- Conditions
- Breakthrough Pain
- Interventions
- Other: No intervention
- Registration Number
- NCT02836379
- Lead Sponsor
- Angelini Farmacéutica
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Breakthrough Cancer Pain No intervention No intervention (Non-interventional study)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
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
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
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
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
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
Trial Locations
- Locations (11)
Hospital de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital de l'Esperança
🇪🇸Barcelona, Spain
Hospital Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
ICO Hospitalet
🇪🇸Barcelona, Spain
Hospital Regional de Málaga
🇪🇸Málaga, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Do Meixoeiro
🇪🇸Vigo, Pontevedra, Spain
Centro Oncológico de galicia
🇪🇸A Coruña, Spain