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

NCT ID: NCT02836379

Last Updated: 2018-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-08

Study Completion Date

2018-02-28

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.

Detailed Description

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Conditions

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Breakthrough Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breakthrough Cancer Pain

No intervention (Non-interventional study)

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Angelini Farmacéutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Mañas, MD

Role: STUDY_DIRECTOR

IMONCOLOGY, Hospital la Milagrosa. Madrid

Locations

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Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status

Hospital de Terrassa

Terrassa, Barcelona, Spain

Site Status

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status

Hospital Do Meixoeiro

Vigo, Pontevedra, Spain

Site Status

Centro Oncológico de galicia

A Coruña, , Spain

Site Status

Hospital de l'Esperança

Barcelona, , Spain

Site Status

ICO Hospitalet

Barcelona, , Spain

Site Status

Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

Hospital Regional de Málaga

Málaga, , Spain

Site Status

Hospital Virgen Macarena

Seville, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 33289432 (View on PubMed)

Other Identifiers

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ANG-DOL-2016-01 (CAVIDIOR)

Identifier Type: -

Identifier Source: org_study_id

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