The Impact of SPC on Advanced Breast Cancer Patients

An observational study of Breast Cancer and Palliative Care, run by Silesian University of Medicine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 33 to 91 years, women only
Conditions the study is for: Breast Cancer, Palliative Care, Quality of Life
What is being tested?: Specialist Palliative Care
Type of treatment: Surgery or procedure
How many people: 144 participants
Where: No sites listed yet
Study dates: 1 May 2015to 1 May 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 33 to 91 years
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

About this study

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

Conditions: Breast Cancer, Palliative Care, Quality of Life, Cancer, Breast
Being tested: Specialist Palliative Care
Keywords: Breast Cancer, palliative care, life quality, performance status, esas
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Specialist Palliative CareProcedure or surgery
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

Study groups in NCT03612934
Study group	Role	What they receive
patients under the age of 65 years		patients under the age of 65 years Receives: Procedure: Specialist Palliative Care
patients at the age of 65 years and over		patients at the age of 65 years and over Receives: Procedure: Specialist Palliative Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Variation of intensification of patients negative symptoms before and after SPC
intensification of patients negative symptoms was assessed by Edmonton Symptom Assessment System (esas)
Measured: 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)
Measured: 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)
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20151 May 2018

First posted2 Aug 2018
Study start1 May 2015
Primary completion1 May 2018
Study completion1 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03612934
Sponsor's protocol ID: SPC1
Status last verified: Jul 2018
First submitted: 9 Jul 2018
Last updated: 2 Aug 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03612934
Acronym / sponsor ID: SPC1
Conditions: Breast Cancer, Palliative Care, Quality of Life, Cancer, Breast
Keywords: Breast Cancer, palliative care, life quality, performance status, esas
Study type: Observational
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Silesian University of MedicineUniversity, hospital or other
Study start: 1 May 2015 (actual)
Primary completion: 1 May 2018 (actual)
Study completion: 1 May 2018 (actual)
First posted: 2 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
patients under the age of 65 years	–	Procedure: Specialist Palliative Carepatients under the age of 65 years
patients at the age of 65 years and over	–	Procedure: Specialist Palliative Carepatients at the age of 65 years and over

Who may qualify

Ages: 33 to 91 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with advanced stage breast cancer refered for a SPC treatment at palliative care department in Poland, Będzin.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Specialist Palliative CareIn 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	Procedure or surgery	patients at the age of 65 years and over, patients under the age of 65 years

Primary outcome

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)
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)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
Individual participant dataSharing planned: Undecided

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jadwiga Jośko-Ochojska, prof study chair

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

Łukasz Pietrzyńsi principal investigator

1. Medical University of Silesia, department of palliative medicine

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Palliative Care, run by Silesian University of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation of intensification of patients negative symptoms before and after SPC (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03612934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.