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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

Tracking Information
First Submitted Date January 29, 2018
First Posted Date February 15, 2018
Last Update Posted Date March 2, 2020
Actual Study Start Date December 21, 2017
Actual Primary Completion Date January 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2018)
Changes in quality of life of the patients [ Time Frame: Up to 4 weeks ]
Changes according to EQ-5D-5L questionnaire
Original Primary Outcome Measures
 (submitted: February 14, 2018)
Quality of life [ Time Frame: Up to 4 weeks ]
Changes according to EQ-5D-5L questionnaire
Change History
Current Secondary Outcome Measures
 (submitted: February 14, 2018)
  • Characteristics of patients [ Time Frame: At baseline ]
    Kind of tumor.
  • Characteristics of patients [ Time Frame: At baseline ]
    Demographic data
  • Characteristics of patients [ Time Frame: At baseline ]
    ECOG
  • Management of cancer breakthrough pain. [ Time Frame: Up to 4 weeks ]
    Cancer breakthrough pain characteristics (time until maximum intensity)
  • Management of cancer breakthrough pain. [ Time Frame: Up to 4 weeks ]
    Cancer breakthrough pain evolution (duration and management)
  • 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.
  • Sleep quality and the possible relationship between this factor and quality of life. [ Time Frame: Up to 4 weeks ]
    MOS sleep questionnaire
  • Evaluate caregivers effort [ Time Frame: Up to 4 weeks ]
    Results according to caregivers effort Index
  • Perceived assistance quality by patients [ Time Frame: Up to 4 weeks ]
    Results according to Sociofamily evaluation scale of "Gijon"
  • 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)
  • Improvement impression perceived by patients [ Time Frame: Up to 4 weeks ]
    Results according to Satisfaction questionnaire PGI-I
  • Improvement impression perceived by patients [ Time Frame: Up to 4 weeks ]
    Results according to Satisfaction questionnaire CGI-I
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)
Official Title Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with breakthrough cancer pain treated in Medical Oncology services
Condition Breakthrough Pain
Intervention Other: No intervention
No intervention
Study Groups/Cohorts Breakthrough Cancer Pain
No intervention (Non Interventional Study)
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 7, 2020)
118
Original Estimated Enrollment
 (submitted: February 14, 2018)
152
Actual Study Completion Date February 14, 2020
Actual Primary Completion Date January 24, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03435120
Other Study ID Numbers ANG-ANA-2017-01 (CAVIDIOM)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Angelini Farmacéutica
Study Sponsor Angelini Farmacéutica
Collaborators Apices Soluciones S.L.
Investigators
Principal Investigator: Carlos Camps Herrero Hospital General Universitario de Valencia
PRS Account Angelini Farmacéutica
Verification Date February 2020