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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435120
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : March 2, 2020
Sponsor:
Collaborator:
Apices Soluciones S.L.
Information provided by (Responsible Party):
Angelini Farmacéutica

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Breakthrough Pain Other: No intervention

Study Design
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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : January 24, 2020
Actual Study Completion Date : February 14, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Breakthrough Cancer Pain
No intervention (Non Interventional Study)
 Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Changes in quality of life of the patients [ Time Frame: Up to 4 weeks ]
    Changes according to EQ-5D-5L questionnaire


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with breakthrough cancer pain treated in Medical Oncology services
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435120


Locations
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Spain
Complexo Hospitalario Universitario de Santiago
Santiago De Compostela, A Coruña, Spain, 15706
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33011
Hospital Principe de Asturias
Alcalá De Henares, Madrid, Spain
Hospital Universitari Son Espases
Palma De Mallorca, Palma, Spain
Hospital Universitari de San Joan de Reus
Reus, Tarragona, Spain, 43204
Hospital Verge de la Cinta
Tortosa, Tarragona, Spain, 43500
Hospital San Pedro de Alcántara
Cáceres, Spain, 10002
Hospital Arnau de Vilanova
Lleida, Spain, 25198
Hospital Universitario La Paz
Madrid, Spain, 28023
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Alvaro Cunqueiro
Vigo, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Angelini Farmacéutica
Apices Soluciones S.L.
Investigators
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Principal Investigator: Carlos Camps Herrero Hospital General Universitario de Valencia
More Information
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Responsible Party: Angelini Farmacéutica
ClinicalTrials.gov Identifier: NCT03435120    
Other Study ID Numbers: ANG-ANA-2017-01 (CAVIDIOM)
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angelini Farmacéutica:
Breakthrough Cancer Pain
Quality of life
Medical Oncology
Additional relevant MeSH terms:
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Cancer Pain
Breakthrough Pain
Pain
Neurologic Manifestations