Breakthrough PainCAVIDIOMNCT03435120
Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)
An observational study of Breakthrough Pain, run by Angelini Farmacéutica at 14 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Pain
- How many people
- 118 participants
- Where
- 14 sitesSpain
- Study dates
- 21 Dec 2017to 14 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breakthrough cancer pain treated in Medical Oncology services
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital Principe de Asturias
Alcalá de Henares, Madrid
Hospital San Pedro de Alcántara
Cáceres, 10002
Hospital Arnau de Vilanova
Lleida, 25198
Hospital Universitario La Paz
Madrid, 28023
Hospital Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Universitari Son Espases
Palma de Mallorca, Palma
Hospital Universitari de San Joan de Reus
Reus, Tarragona, 43204
Hospital Universitario de Salamanca
Salamanca, 37007
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Hospital Verge de la Cinta
Tortosa, Tarragona, 43500
Hospital Alvaro Cunqueiro
Vigo
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services
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.
- Conditions
- Breakthrough Pain
- Being tested
- No intervention
- Keywords
- Breakthrough Cancer Pain, Quality of life, Medical Oncology
- Medical subject headings
- Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Breakthrough Cancer Pain | No intervention (Non Interventional Study) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life of the patients
Changes according to EQ-5D-5L questionnaire
Measured: Up to 4 weeks
Secondary outcomes (12)
Characteristics of patients
Kind of tumor.
Measured: At baseline
Characteristics of patients
Demographic data
Measured: At baseline
Characteristics of patients
ECOG
Measured: At baseline
Management of cancer breakthrough pain.
Cancer breakthrough pain characteristics (time until maximum intensity)
Measured: Up to 4 weeks
Management of cancer breakthrough pain.
Cancer breakthrough pain evolution (duration and management)
Measured: Up to 4 weeks
Anxiety and depression status and the possible relationship between these factors and quality of life.
Goldberg Anxiety and Depression Scale.
Measured: Up to 4 weeks
Sleep quality and the possible relationship between this factor and quality of life.
MOS sleep questionnaire
Measured: Up to 4 weeks
Evaluate caregivers effort
Results according to caregivers effort Index
Measured: Up to 4 weeks
Perceived assistance quality by patients
Results according to Sociofamily evaluation scale of "Gijon"
Measured: Up to 4 weeks
Improvement impression perceived by patients
Results according to assessment of perceived quality (questionnaire of the Ministry of Health and Consumer Affairs)
Measured: Up to 4 weeks
Improvement impression perceived by patients
Results according to Satisfaction questionnaire PGI-I
Measured: Up to 4 weeks
Improvement impression perceived by patients
Results according to Satisfaction questionnaire CGI-I
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start21 Dec 2017
- Primary completion24 Jan 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakthrough PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angelini Farmacéutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Sponsor
- Investigators
- Carlos Camps Herrero, Principal investigator, Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435120
- Sponsor's protocol ID
- ANG-ANA-2017-01 (CAVIDIOM)
- Acronym
- CAVIDIOM
- Status last verified
- Feb 2020
- First submitted
- 29 Jan 2018
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services
- ClinicalTrials.gov ID
- NCT03435120
- Acronym / sponsor ID
- CAVIDIOM / ANG-ANA-2017-01 (CAVIDIOM)
- Conditions
- Breakthrough Pain
- Keywords
- Breakthrough Cancer Pain, Quality of life, Medical Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Angelini FarmacéuticaIndustry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L.
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breakthrough Cancer Pain | – | Other: No interventionNo intervention (Non Interventional Study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breakthrough cancer pain treated in Medical Oncology services
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Breakthrough Cancer Pain |
Primary outcome
Changes in quality of life of the patients
Time frame: Up to 4 weeks
Changes according to EQ-5D-5L questionnaire
12 secondary outcomes
Characteristics of patients
Time frame: At baseline
Characteristics of patients
Time frame: At baseline
Characteristics of patients
Time frame: At baseline
Management of cancer breakthrough pain.
Time frame: Up to 4 weeks
Management of cancer breakthrough pain.
Time frame: Up to 4 weeks
Anxiety and depression status and the possible relationship between these factors and quality of life.
Time frame: Up to 4 weeks
Sleep quality and the possible relationship between this factor and quality of life.
Time frame: Up to 4 weeks
Evaluate caregivers effort
Time frame: Up to 4 weeks
Perceived assistance quality by patients
Time frame: Up to 4 weeks
Improvement impression perceived by patients
Time frame: Up to 4 weeks
Improvement impression perceived by patients
Time frame: Up to 4 weeks
Improvement impression perceived by patients
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Camps Herrero principal investigator
Hospital General Universitario de Valencia
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breakthrough Pain, run by Angelini Farmacéutica at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life of the patients (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.