Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units

NCT02840500 | Completed

• 1 other identifier: ANG-OPI-2016-01 (CAVIDIOPAL)
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 10

Brief Summary

Patients treated in Palliative Care Units are potentially fragile patients, especially in our case, which are cancer patients. The management of these patients is usually done from experience, because these patients rarely meet criteria for clinical trials, as their inclusion could affect results obtained in the trial. There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in palliative care units 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 treated in palliative care units as well as the characteristics of these patients. This post-authorization observational study will assess the quality of life of patients with breakthrough cancer pain treated in Palliative Care Units in Spanish hospitals.

Conditions

Breakthrough Pain

Keywords

Breakthrough Cancer Pain; Quality of life; Palliative Care Units

Outcome Measures

Primary Outcomes (1)

• Change in quality of life according EORTC QLQ-C30 questionnaire

  Change in punctuation of the EORTC QLQ-C30 questionnaire between week 4 and baseline.

  Baseline and 4 weeks

Secondary Outcomes (8)

• Percentage of patients with neuropathic, visceral, somatic and mixed pain

  Baseline (the day that patient sign the informed consent form)

• Comorbidities associated with patients

  Baseline (the day that patient sign the informed consent form)

• Change in mean Intensity of breakthrough cancer pain at each study visit

  Up to 4 weeks, from date of inclusion until week 4

• Mean time to relief of breakthrough pain

  Up to 4 weeks, from date of inclusion until week 4

• Mean duration of the episodes of breakthrough pain

  Up to 4 weeks, from date of inclusion until week 4

Study Arms (1)

Breakthrough Cancer Pain

No intervention (Non-interventional study)

Other: No intervention

Interventions

No intervention OTHER

No intervention

Breakthrough Cancer Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breakthrough cancer pain attended in Palliative Care Units will be included

You may qualify if:

• Patients \> 18 years
• Patients with advanced cancer
• Patients attended in Palliative Care Units
• Life expectancy\> 3 months
• Written informed consent
• Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm

You may not qualify if:

• Serious psychiatric disorder, cognitive impairment or any disease or condition that prevents the collection of data
• Patients with evidence of opioid addiction or history of drug or alcohol abuse

Sponsors & Collaborators

• Angelini Farmacéutica: lead

Study Sites (10)

Hospital de Mollet

Mollet del Vallès, Barcelona, 08100, Spain

Location

Hospital Sant Joan de Deu

Palma, Illes Baleares, 07007, Spain

Location

Hospital Clínic

Barcelona, 08036, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Complejo Hospitalario de Ourense

Ourense, 32005, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Virgen de la Salud

Toledo, 45005, Spain

Location

Related Publications (2)

• Rodriguez AT, Viejo MN, Maradey P, Canal-Sotelo J, Mancilla PG, Rivero SG, Casillas IR, Abian MH, Bermudo CL. Low-dose sublingual fentanyl improves quality of life in patients with breakthrough cancer pain in palliative care. Future Oncol. 2022 May;18(14):1717-1731. doi: 10.2217/fon-2021-1639. Epub 2022 Feb 9.

  PMID: 35137627 DERIVED

• Tuca Rodriguez A, Nunez Viejo M, Maradey P, Canal-Sotelo J, Guardia Mancilla P, Gutierrez Rivero S, Raja Casillas I, Herrera Abian M, Lopez Bermudo C. Impact of individualized management of breakthrough cancer pain on quality of life in advanced cancer patients: CAVIDIOPAL study. Support Care Cancer. 2021 Aug;29(8):4799-4807. doi: 10.1007/s00520-021-06006-1. Epub 2021 Feb 3.

  PMID: 33533986 DERIVED

MeSH Terms

Conditions

Breakthrough Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Albert Tuca, MD

  Hospital Clinic de Barcelona, Palliative Care Unit

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: June 27, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)