Skip to main content
OpenTrials
Completed

NCT Number: NCT03435120

Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)

In cancer patients, pain is one of the most common symptoms. The range of reported prevalence of pain varies from 33% to 64% including different stages of cancer, during or after anticancer treatment. Moreover, despite the optimal management of basal chronic pain, 66% of these patients have reported breakthrough pain which has a severe impact on quality of life. There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in medical oncology services according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain in medical oncology services as well as other factors that can affect quality of life. This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in medical oncology services in Spanish hospitals.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 18 years
  • Patients with histologically confirmed neoplasia
  • Patients attended in medical oncology consultations
  • Life expectancy > 3 months
  • Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm
  • Written informed consent

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Changes in quality of life of the patients

    Time frame: Up to 4 weeks

    Changes according to EQ-5D-5L questionnaire

Secondary outcomes

  1. Characteristics of patients

    Time frame: At baseline

    Kind of tumor.

  2. Characteristics of patients

    Time frame: At baseline

    Demographic data

  3. Characteristics of patients

    Time frame: At baseline

    ECOG

  4. Management of cancer breakthrough pain.

    Time frame: Up to 4 weeks

    Cancer breakthrough pain characteristics (time until maximum intensity)

  5. Management of cancer breakthrough pain.

    Time frame: Up to 4 weeks

    Cancer breakthrough pain evolution (duration and management)

  6. Anxiety and depression status and the possible relationship between these factors and quality of life.

    Time frame: Up to 4 weeks

    Goldberg Anxiety and Depression Scale.

  7. Sleep quality and the possible relationship between this factor and quality of life.

    Time frame: Up to 4 weeks

    MOS sleep questionnaire

  8. Evaluate caregivers effort

    Time frame: Up to 4 weeks

    Results according to caregivers effort Index

  9. Perceived assistance quality by patients

    Time frame: Up to 4 weeks

    Results according to Sociofamily evaluation scale of "Gijon"

  10. Improvement impression perceived by patients

    Time frame: Up to 4 weeks

    Results according to assessment of perceived quality (questionnaire of the Ministry of Health and Consumer Affairs)

  11. Improvement impression perceived by patients

    Time frame: Up to 4 weeks

    Results according to Satisfaction questionnaire PGI-I

  12. Improvement impression perceived by patients

    Time frame: Up to 4 weeks

    Results according to Satisfaction questionnaire CGI-I

Sponsors and collaborators

Lead sponsor

Angelini Farmacéutica

Industry

Collaborators

  • Apices Soluciones S.L.

Registry information

Official study title

Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services

Acronym: CAVIDIOM

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2018
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.