The Impact of SPC on Advanced Breast Cancer Patients

July 26, 2018 updated by: Łukasz Pietrzyński, Silesian University of Medicine

The Influence of Specialist Palliative Care on the Exacerbation of Negative Symptoms, Life Quality and Performance Status of Patients With Advanced Breast Cancer

The aim of this prospective, observational study is the evaluation of the effectiveness of a 14-day Specialist Palliative Care therapy in participants with advanced breast cancer carried out in a stationary palliative care unit in Poland. The length of the entire study will be 36 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

144

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced stage breast cancer refered for a SPC treatment at palliative care department in Poland, Będzin.

Description

Inclusion Criteria:

the patient's conscious consent for examination and the ability to fill in the form by the patient herself.

-

Exclusion Criteria:

  • patients with cognitive disturbances disabling credible answers in the questionnaire, deceased patients or those discharged from the ward before 14 days of hospitalisation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients under the age of 65 years
Procedure: Specialist Palliative Care
In the research, Specialist Palliative Care was provided according to the guidelines established by Mid-Western Health Board in a Report of the National Advisory Committee on Palliative Care as well as according to recommendations of Polish Society of Palliative Medicine and Polish National Healthcare Fund. In order to ensure interdisciplinary and integrated palliative care, a team of specialists was appointed. Team members were engaged in the process of treatment of each patient during the time of the study and applied their specialist skills according to the needs of the patients
patients at the age of 65 years and over
Procedure: Specialist Palliative Care
In the research, Specialist Palliative Care was provided according to the guidelines established by Mid-Western Health Board in a Report of the National Advisory Committee on Palliative Care as well as according to recommendations of Polish Society of Palliative Medicine and Polish National Healthcare Fund. In order to ensure interdisciplinary and integrated palliative care, a team of specialists was appointed. Team members were engaged in the process of treatment of each patient during the time of the study and applied their specialist skills according to the needs of the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of intensification of patients negative symptoms before and after SPC
Time Frame: 14 days
intensification of patients negative symptoms was assessed by Edmonton Symptom Assessment System (esas)
14 days
Variation of performance status of patients before and after SPC
Time Frame: 14 days
performance status of patients was assessed by ECOG scale (Eastern Cooperative Oncology Group)
14 days
Variation of quality of life of patients before and after SPC
Time Frame: 14 days
quality of life of patients of patients was assessed by quality of life uniscale (QoLU)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silesian University of Medicine

Investigators

  • Study Chair: Jadwiga Jośko-Ochojska, prof, 4. Chair and Department of Medicine and Environmental Epidemiology Medical University of Silesia in Katowice
  • Principal Investigator: Łukasz Pietrzyńsi, 1. Medical University of Silesia, department of palliative medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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