Metastatic Breast CancerNCT02730858
Palliative and Oncology Care Model in Breast Cancer
A study testing Palliative and Oncology Care and Standard Oncology Care in people with Metastatic Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to test a new way to deliver oncology and palliative care for patients with metastatic breast cancer. The goal of this study is to test a model where oncology and palliative care work together to care for participants with metastatic breast cancer who were recently admitted to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Palliative and Oncology Care and Standard Oncology Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Mar 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with metastatic breast cancer and:
- have been informed of a diagnosis of leptomeningeal disease in the past eight weeks; OR
- have been informed of a diagnosis of progressive brain metastases after initial radiation therapy in the past eight weeks; OR
- have been diagnosed brain metastases and began whole brain radiation in the past eight weeks; OR
- had an unplanned hospital admission and was discharged within the past eight weeks; OR
- have been diagnosed with triple negative breast cancer and started second-line treatment in the past eight weeks; OR
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- have started the third regimen in one year within the past eight weeks; OR
- have HER2+ disease and started third-line therapy within the past eight weeks; OR
- have ER+ disease and started third-line chemotherapy within the past eight weeks; OR
- enrolled on a clinical trial within the past eight weeks
- Receiving cancer care at MGH Cancer Center.
- Able to read and write in English.
- Eastern Cooperative Oncology Group status between 0 and 2.
Who cannot join
- Already receiving palliative care in the outpatient setting.
- Active, untreated, unstable, serious mental illness (e.g., active, untreated psychotic, bi-polar, or substance-dependence disorder) interfering with ability to participate.
- Cognitive impairment (e.g., delirium, dementia) interfering with ability to participate.
- Requires urgent palliative or hospice care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Collaborative Palliative and Oncology Care Model for Metastatic Breast Cancer
The purpose of this research study is to test a new way to deliver oncology and palliative care for patients with metastatic breast cancer.
- The goal of this study is to test a model where oncology and palliative care work together to care for participants with metastatic breast cancer who were recently admitted to the hospital or have new or worsening cancer involving their brain or the fluid around the brain or spinal cord.
- The investigators are studying whether participants who receive care from both teams have better communication about their care and improved quality of life and mood compared to those receiving care from only their oncologists.
The purpose of this randomized clinical trial is to conduct a randomized trial testing the impact of the collaborative palliative and oncology care model or standard oncology care models among patients with poor prognosis metastatic breast cancer. Participants assigned to the intervention arm will participate in a series of structured palliative care visits, following tailored clinical practice guidelines previously developed for patients with metastatic breast cancer.
Read the detailed description
This research study tests whether or not the earlier introduction of a team of clinicians that specialize in the lessening (palliation) of symptoms and addressing quality of life concerns may improve the end-of-life care, quality of life, and mood of women with poor prognosis metastatic breast cancer.
Palliative care is a specific type of medical care given to patients to improve their pain and other symptoms like fatigue, and to support patients and their families as they cope with their illness. Palliative care includes physicians and advanced practice nurses who have been specifically trained in how to help patients with serious illness.
Increasingly, the role of palliative care has been shown to benefit patients when introduced early in the disease trajectory. For example, in patients with metastatic (or spread) lung cancer, early involvement of palliative care improves patients' quality of life and mood. Patients with some metastatic cancers, like breast cancer, have an unpredictable disease trajectory, which makes it difficult to determine the best time to introduce palliative care services.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Palliative and Oncology Care, Standard Oncology Care
- Keywords
- Metastatic Breast Cancer, Palliative Care, Breast Cancer, End of life, Health service research
- Medical subject headings
- Breast Neoplasms, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative and Oncology CareBehavioural
Patients randomized to the intervention will receive collaborative care from palliative care and oncology for the remainder of their illness. The initial five visits with palliative care will be conducted in accordance with the study specific clinical practice guidelines and occur at least monthly.
Standard Oncology CareBehavioural
Patients randomized to oncology care alone will continue to receive routine care identical to what they would have received if they had not participated in the trial. Either patients or their oncologists can request palliative care consultation at any point in time.
| Study group | Role | What they receive |
|---|---|---|
| Palliative and oncology care model | Experimental | After the screening procedure confirm eligibility to participate in the research study. Participants will be randomized into one of two study groups;
-- Standard oncology care with palliative care. Receives: Behavioral: Palliative and Oncology Care |
| Standard oncology care | Active comparator | After the screening procedure confirm eligibility to participate in the research study. Participants will be randomized into one of two study groups;
-- Standard oncology care Receives: Behavioral: Standard Oncology Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of life care preference documentation
Compare differences in rate of documentation of end of life care preferences (Yes documented vs. No)
Measured: 1 year
Secondary outcomes (7)
Patient-reported end of life care conversation
Examine patient report of end of life care preferences with their clinician using the following item: "have you and your doctors discussed any particular wishes you have about the care you want to receive if you were dying?" Although patients complete this measure repeatedly during the course of the study, the investigators will use the final assessment either prior to death or at six months follow-up (whichever comes first) for this analysis.
Measured: 6 months
Patient-reported quality of life (FACT-Breast)
Compare patient-reported quality of life between the two study arms at weeks 6, 12, 18, and 24.
Measured: Weeks 6, 12, 18, and 24
Patient-reported depression symptoms (Hospital Anxiety and Depression Scale)
Compare patient-reported depression symptoms between the two study arms at weeks 6, 12, 18, and 24.
Measured: Weeks 6, 12, 18, and 24
Patient-reported anxiety symptoms (Hospital Anxiety and Depression Scale)
Compare patient-reported anxiety symptoms between the two study arms at weeks 6, 12, 18, and 24.
Measured: Weeks 6, 12, 18, and 24
Chemotherapy at the end of life
Examine differences in rates of chemotherapy administration during the last 3, 7, and 14 days of life between the two study arms
Measured: 14, 7 and 3 days before death
Rate of hospice utilization at the end of life
Examine difference the in rates of hospice utilization between the two study arms.
Measured: 6 months
Length of stay on hospice
Examine difference in hospice length-of-stay between the two study arms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2019
- Study completionMar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Jennifer Temel, MD, Massachusetts General Hospital
- Investigators
- Jennifer Temel, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730858
- Sponsor's protocol ID
- 15-585
- Status last verified
- Sep 2024
- First submitted
- 24 Mar 2016
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
PubMed 35802350Greer JA, Moy B, El-Jawahri A, Jackson VA, Kamdar M, Jacobsen J, Lindvall C, Shin JA, Rinaldi S, Carlson HA, Sousa A, Gallagher ER, Li Z, Moran S, Ruddy M, Anand MV, Carp JE, Temel JS. Randomized Trial of a Palliative Care Intervention to Improve End-of-Life Care Discussions in Patients With Metastatic Breast Cancer. J Natl Compr Canc Netw. 2022 Feb;20(2):136-143. doi: 10.6004/jnccn.2021.7040.
PubMed 35130492
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Palliative and Oncology Care Model for Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02730858
- Acronym / sponsor ID
- 15-585
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Palliative Care, Breast Cancer, End of life, Health service research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- May 2016
- Primary completion
- Sep 2019 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 7 Apr 2016 (estimated)
- 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.
The purpose of this research study is to test a new way to deliver oncology and palliative care for patients with metastatic breast cancer.
- The goal of this study is to test a model where oncology and palliative care work together to care for participants with metastatic breast cancer who were recently admitted to the hospital or have new or worsening cancer involving their brain or the fluid around the brain or spinal cord.
- The investigators are studying whether participants who receive care from both teams have better communication about their care and improved quality of life and mood compared to those receiving care from only their oncologists.
The purpose of this randomized clinical trial is to conduct a randomized trial testing the impact of the collaborative palliative and oncology care model or standard oncology care models among patients with poor prognosis metastatic breast cancer. Participants assigned to the intervention arm will participate in a series of structured palliative care visits, following tailored clinical practice guidelines previously developed for patients with metastatic breast cancer.
Detailed description
This research study tests whether or not the earlier introduction of a team of clinicians that specialize in the lessening (palliation) of symptoms and addressing quality of life concerns may improve the end-of-life care, quality of life, and mood of women with poor prognosis metastatic breast cancer.
Palliative care is a specific type of medical care given to patients to improve their pain and other symptoms like fatigue, and to support patients and their families as they cope with their illness. Palliative care includes physicians and advanced practice nurses who have been specifically trained in how to help patients with serious illness.
Increasingly, the role of palliative care has been shown to benefit patients when introduced early in the disease trajectory. For example, in patients with metastatic (or spread) lung cancer, early involvement of palliative care improves patients' quality of life and mood. Patients with some metastatic cancers, like breast cancer, have an unpredictable disease trajectory, which makes it difficult to determine the best time to introduce palliative care services.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palliative and oncology care model | Experimental | Behavioral: Palliative and Oncology CareAfter the screening procedure confirm eligibility to participate in the research study. Participants will be randomized into one of two study groups; -- Standard oncology care with palliative care. |
| Standard oncology care | Active comparator | Behavioral: Standard Oncology CareAfter the screening procedure confirm eligibility to participate in the research study. Participants will be randomized into one of two study groups; -- Standard oncology care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosed with metastatic breast cancer and:
- Receiving cancer care at MGH Cancer Center.
- Able to read and write in English.
- Eastern Cooperative Oncology Group status between 0 and 2.
Key exclusion criteria (4 listed)
- Already receiving palliative care in the outpatient setting.
- Active, untreated, unstable, serious mental illness (e.g., active, untreated psychotic, bi-polar, or substance-dependence disorder) interfering with ability to participate.
- Cognitive impairment (e.g., delirium, dementia) interfering with ability to participate.
- Requires urgent palliative or hospice care.
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 |
|---|---|---|
| Palliative and Oncology CarePatients randomized to the intervention will receive collaborative care from palliative care and oncology for the remainder of their illness. The initial five visits with palliative care will be conducted in accordance with the study specific clinical practice guidelines and occur at least monthly. | Behavioural | Palliative and oncology care model |
| Standard Oncology CarePatients randomized to oncology care alone will continue to receive routine care identical to what they would have received if they had not participated in the trial. Either patients or their oncologists can request palliative care consultation at any point in time. | Behavioural | Standard oncology care |
Primary outcome
End of life care preference documentation
Time frame: 1 year
Compare differences in rate of documentation of end of life care preferences (Yes documented vs. No)
7 secondary outcomes
Patient-reported end of life care conversation
Time frame: 6 months
Patient-reported quality of life (FACT-Breast)
Time frame: Weeks 6, 12, 18, and 24
Patient-reported depression symptoms (Hospital Anxiety and Depression Scale)
Time frame: Weeks 6, 12, 18, and 24
Patient-reported anxiety symptoms (Hospital Anxiety and Depression Scale)
Time frame: Weeks 6, 12, 18, and 24
Chemotherapy at the end of life
Time frame: 14, 7 and 3 days before death
Rate of hospice utilization at the end of life
Time frame: 6 months
Length of stay on hospice
Time frame: 6 months
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 19 Sep 2024.
- Derived from this study: PubMed 35802350Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
- Derived from this study: PubMed 35130492Greer JA, Moy B, El-Jawahri A, Jackson VA, Kamdar M, Jacobsen J, Lindvall C, Shin JA, Rinaldi S, Carlson HA, Sousa A, Gallagher ER, Li Z, Moran S, Ruddy M, Anand MV, Carp JE, Temel JS. Randomized Trial of a Palliative Care Intervention to Improve End-of-Life Care Discussions in Patients With Metastatic Breast Cancer. J Natl Compr Canc Netw. 2022 Feb;20(2):136-143. doi: 10.6004/jnccn.2021.7040.
- Individual participant dataSharing planned: No
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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.
Jennifer Temel, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative and Oncology Care and Standard Oncology Care in people with Metastatic Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
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 13 inclusion and 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
End of life care preference documentation (time frame: 1 year). 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 NCT02730858, which also lists 2 linked publications.
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 19 Sep 2024.