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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05629065
Other study ID # 22-501
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 28, 2022
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The objective of this study is to implement an intervention in a pragmatic randomized controlled trial that uses cancer treatment pathways data to identify patients appropriate for serious illness conversations (SICs) and applies "nudges" to patients and their oncology clinicians to increase SICs and improve end of life (EOL) outcomes. Identified participants and clinicians will be randomized into 1 or 4 groups. - Nudge to patient and clinician - Nudge to patient only - Nudge to clinician only - No nudge. The expected enrollment is approximately 800 participants.


Recruitment information / eligibility

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)

Study Design


Intervention

Other:
Clinician Nudge Email
-Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit
Patient Nudge Letter and Share questionaire
Involves patient nudge consists of a letter and SHARE questionnaire - patient nudge is a letter and a SHARE questionnaire encourages the participant to complete the SHARE questionnaire, which asks questions about the participants goals and preferences around cancer care, and discuss the questionnaire with their oncology clinician at the next visit.

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

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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