Quality of Life Study Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent

Study Overview
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Brief Summary
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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.

Official Title
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Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent

Conditions
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Breakthrough Pain

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breakthrough Cancer Pain<br>No intervention (Non-interventional study) | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life according SF-12 questionnaire | Change in punctuation of the SF-12 questionnaire between end of radiotherapy treatment and baseline. | Baseline and 4-6 weeks (estimated end of radiotherapy treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with neuropathic, visceral, somatic and mixed pain | Percentage of patients with neuropathic, visceral, somatic and mixed pain | Baseline (the day that patient sign the informed consent form) | 
| Comorbidities associated with patients | Percentage of patients with each comorbidity | 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 | 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 | 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 | 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 | 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. | 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. | 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 | Baseline and 4-6 weeks (estimated end of radiotherapy treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breakthrough Cancer Pain, Quality of life, Radiotherapy