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

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

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.

Study Overview

• Status: Completed
• Conditions: Breakthrough Pain
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15009
    • Centro Oncológico de Galicia
  • Barcelona, Spain, 08024
    • Hospital de l'Esperança
  • Barcelona, Spain, 08908
    • ICO Hospitalet
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Málaga, Spain, 29010
    • Hospital Regional de Malaga
  • Sevilla, Spain, 41007
    • Hospital Virgen Macarena
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago
  • Barcelona
    • Terrassa, Barcelona, Spain, 08227
      • Hospital de Terrassa
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Puerta de Hierro
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36200
      • Hospital Do Meixoeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breakthrough Cancer Pain; No intervention (Non-interventional study)	Other: No intervention; No intervention

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Angelini Farmacéutica
• Investigators: Study Director: Ana Mañas, MD, IMONCOLOGY, Hospital la Milagrosa. Madrid

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2018
• Last Update Submitted That Met QC Criteria: March 2, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Quality of life; Radiotherapy; Breakthrough Cancer Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Breakthrough Pain; Cancer Pain
• Other Study ID Numbers: ANG-DOL-2016-01 (CAVIDIOR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No