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Completed

NCT Number: NCT03612934

The Impact of SPC on Advanced Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer, Breast Neoplasms Neoplasms by Site Palliative Care Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

33 year–91 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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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.

Treatment and study plan

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Silesian University of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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