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

NCT02836379 | Completed

• 1 other identifier: ANG-DOL-2016-01 (CAVIDIOR)
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 11

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.

Conditions

Breakthrough Pain

Keywords

Breakthrough Cancer Pain; Quality of life; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Percentage of patients with neuropathic, visceral, somatic and mixed pain

  Baseline (the day that patient sign the informed consent form)

• Comorbidities associated with patients

  Baseline (the day that patient sign the informed consent form)

• Mean time to 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

  Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment

• Clinical Global improvement

  4-6 weeks (estimated end of radiotherapy treatment)

Study Arms (1)

Breakthrough Cancer Pain

No intervention (Non-interventional study)

Other: No intervention

Interventions

No intervention OTHER

No intervention

Breakthrough Cancer Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breakthrough cancer pain treated in Radiation Oncology services with palliative intent will be included

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Angelini Farmacéutica: lead

Study Sites (11)

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Do Meixoeiro

Vigo, Pontevedra, 36200, Spain

Location

Centro Oncológico de galicia

A Coruña, 15009, Spain

Location

Hospital de l'Esperança

Barcelona, 08024, Spain

Location

ICO Hospitalet

Barcelona, 08908, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Regional de Málaga

Málaga, 29010, Spain

Location

Hospital Virgen Macarena

Seville, 41007, Spain

Location

Related Publications (1)

• 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.

  PMID: 33289432 DERIVED

MeSH Terms

Conditions

Breakthrough Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Mañas, MD

  IMONCOLOGY, Hospital la Milagrosa. Madrid

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 19, 2016
• Study Start: July 8, 2016
• Primary Completion: November 1, 2017
• Study Completion: February 28, 2018
• Last Updated: March 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (11)