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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breakthrough Cancer Pain | No intervention (Non-interventional study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with breakthrough cancer pain treated in Radiation Oncology services with palliative intent will be included
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| Name | Affiliation | Role |
|---|---|---|
| Ana Mañas, MD | IMONCOLOGY, Hospital la Milagrosa. Madrid | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | A Coruña | 15706 | Spain | ||
| Hospital de Terrassa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33289432 | Derived | Hernanz de Lucas R, Nunez Fernandez M, Gomez-Caamano A, Morera Lopez R, Fortes de la Torre I, de la Torre Tomas A, Munoz-Garzon V, Lopez Bermudo C, Manas Rueda A. Quality of life in patients with breakthrough cancer pain in radiation oncology departments in Spain: the CAVIDIOR study. Future Oncol. 2021 Mar;17(8):943-954. doi: 10.2217/fon-2020-1063. Epub 2020 Dec 8. |
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| ID | Term |
|---|---|
| D059390 | Breakthrough Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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) |
| Terrassa |
| Barcelona |
| 08227 |
| Spain |
| Hospital Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Do Meixoeiro | Vigo | Pontevedra | 36200 | Spain |
| Centro Oncológico de galicia | A Coruña | 15009 | Spain |
| Hospital de l'Esperança | Barcelona | 08024 | Spain |
| ICO Hospitalet | Barcelona | 08908 | Spain |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Regional de Málaga | Málaga | 29010 | Spain |
| Hospital Virgen Macarena | Seville | 41007 | Spain |