Breast Cancer Clinical Trial
— (PATH-SIC)Official title:
Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
Verified date | March 2024 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to increase serious illness conversations (SICs) about patients goals and preferences regarding their healthcare between patients with cancer and their oncology clinicians and improved care provided near the end of life.
Status | Enrolling by invitation |
Enrollment | 800 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who are aged 18 years or older, reach one of the poor prognosis nodes identified and have an upcoming appointment at one of the following Dana Farber Cancer Institute oncology clinics (including Longwood and Chestnut Hill locations) - Breast Oncology Clinic - Gastrointestinal Oncology Clinic - Genitourinary Oncology Clinic - Gynecologic Oncology Clinic - Thoracic Oncology Clinic Exclusion Criteria: - Patients with an SIC documented in the Advance Care Planning module of the electronic health record in the 6 months prior to reaching a poor prognosis node - Patients who have previously been randomized in this trial (e.g., the patient is encountering a poor-prognosis node for the second time during the trial period) |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with an SIC at 60 days for arm 1 (patient +clinician nudge) vs arm 2 (no nudge). | The numerator includes patients with any SIC documentation extracted from the Advanced Care Planning module between the date of the poor prognosis node and 60 days. The denominator is all patients randomized to the applicable study arm. | up to 60 days after reaching the poor prognosis node | |
Secondary | Proportion of patients with an SIC at 60 days, comparison of all 4 study arms | Same as the primary outcome | up to 60 days after reaching the poor prognosis node | |
Secondary | Time from SIC to death among decedents | Time from SIC to death among decedents | randomization up to 1 year | |
Secondary | Receipt of chemotherapy in last 14 days of life | Whether or not the patient received chemotherapy in the last 14 days of life, among decedents | randomization up to 1 year | |
Secondary | ED visits in the last 30 days of life | Number of ED visits in the last 30 days of life, among decedents | randomization up to 1 year | |
Secondary | Hospitalization in last 30 days of life | Hospitalization in the last 30 days of life, among decedents | randomization up to 1 year | |
Secondary | Median length of hospitalization | Median length of last hospitalization, in days among decedents | randomization up to 1 year | |
Secondary | ICU utilization in last 30 days of life | ICU hospitalization in the last 30 days of life, among decedents | randomization up to 1 year | |
Secondary | Death in an acute care facility | Presence or absence of death in an acute care facility like a hospital or emergency room | randomization up to 1 year | |
Secondary | Death in the ICU | Whether or not death occurred in an ICU | randomization up to 1 year | |
Secondary | Hospice enrollment at death | Whether or not the patient was enrolled in hospice on the day of death | randomization up to 1 year | |
Secondary | Enrolled < 4 days in hospice at death | Whether or not the patient was enrolled in hospice for less than 4 days on the day of death | randomization up to 1 year | |
Secondary | Patient preferences | Patient responses on SHARE questionnaire | Up to 60 days after randomization |
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