The Impact of SPC on Advanced Breast Cancer Patients

NCT03612934 | Completed DMC

• 1 other identifier: SPC1
• Study Type: observational
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Palliative Care; Quality of Life; Cancer, Breast

Keywords

Breast Cancer; palliative care; life quality; performance status; esas

Outcome Measures

Primary Outcomes (3)

• Variation of intensification of patients negative symptoms before and after SPC

  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

  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

  quality of life of patients of patients was assessed by quality of life uniscale (QoLU)

  14 days

Study Arms (2)

patients under the age of 65 years

patients under the age of 65 years

Procedure: Specialist Palliative Care

patients at the age of 65 years and over

patients at the age of 65 years and over

Procedure: Specialist Palliative Care

Interventions

Specialist Palliative Care PROCEDURE

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 under the age of 65 years

Eligibility Criteria

• Age: 33 Years - 91 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Silesian University of Medicine: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jadwiga Jośko-Ochojska, prof

  4. Chair and Department of Medicine and Environmental Epidemiology Medical University of Silesia in Katowice

  STUDY CHAIR

• Łukasz Pietrzyńsi

  1. Medical University of Silesia, department of palliative medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 2, 2018
• Study Start: May 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07