The Impact of SPC on Advanced Breast Cancer Patients

Sponsor

Silesian University of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03612934

Collaborator

(none)

144

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Palliative Care Quality of Life Cancer, Breast	Procedure: Specialist Palliative Care

Study Design

Study Type:

Observational

Actual Enrollment :

144 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2015

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
patients under the age of 65 years 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 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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

33 Years to 91 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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