Breast Cancer Clinical Trial
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
| NCT number | NCT03612934 |
| Other study ID # | SPC1 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 1, 2015 |
| Est. completion date | May 1, 2018 |
| Verified date | July 2018 |
| Source | Silesian University of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 144 |
| Est. completion date | May 1, 2018 |
| Est. primary completion date | May 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 33 Years to 91 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Silesian University of Medicine |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |
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