Breast Cancer(PATH-SIC)NCT05629065
Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
A study testing Clinician Nudge Email and Patient Nudge Letter and Share questionaire in people with Breast Cancer and Gastrointestinal Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer
- What is being tested?
- Clinician Nudge Email and Patient Nudge Letter and Share questionaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2022to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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.
Read the detailed 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.
- Conditions
- Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer, Genitourinary Cancer
- Being tested
- Clinician Nudge Email, Patient Nudge Letter and Share questionaire
- Keywords
- Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer, Genitourinary Cancer, Serious Illness Communication
- Medical subject headings
- Breast Neoplasms, Gastrointestinal Neoplasms, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician Nudge EmailOther
-Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit
Patient Nudge Letter and Share questionaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Both patient and clinician receive a nudge | Experimental | * Patient nudge consists of a letter and SHARE questionnaire
* Clinician "nudge" email encouraging discussion to initiate discussion on SIC Receives: Other: Clinician Nudge Email; Other: Patient Nudge Letter and Share questionaire |
| Neither the patient nor clinician receive a nudge | No intervention | Standard Care |
| Patient receives a nudge but not the clinician | Experimental | -Patient nudge consists of a letter and SHARE questionnaire Receives: Other: Patient Nudge Letter and Share questionaire |
| Clinician receives a nudge but not the patient | Experimental | -Clinician "nudge" email encouraging discussion to initiate discussion on SIC Receives: Other: Clinician Nudge Email |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 60 days after reaching the poor prognosis node
Secondary outcomes (12)
Proportion of patients with an SIC at 60 days, comparison of all 4 study arms
Same as the primary outcome
Measured: up to 60 days after reaching the poor prognosis node
Time from SIC to death among decedents
Time from SIC to death among decedents
Measured: randomization up to 1 year
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
Measured: randomization up to 1 year
ED visits in the last 30 days of life
Number of ED visits in the last 30 days of life, among decedents
Measured: randomization up to 1 year
Hospitalization in last 30 days of life
Hospitalization in the last 30 days of life, among decedents
Measured: randomization up to 1 year
Median length of hospitalization
Median length of last hospitalization, in days among decedents
Measured: randomization up to 1 year
ICU utilization in last 30 days of life
ICU hospitalization in the last 30 days of life, among decedents
Measured: randomization up to 1 year
Death in an acute care facility
Presence or absence of death in an acute care facility like a hospital or emergency room
Measured: randomization up to 1 year
Death in the ICU
Whether or not death occurred in an ICU
Measured: randomization up to 1 year
Hospice enrollment at death
Whether or not the patient was enrolled in hospice on the day of death
Measured: randomization up to 1 year
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
Measured: randomization up to 1 year
Patient preferences
Patient responses on SHARE questionnaire
Measured: Up to 60 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start28 Nov 2022
- Primary completion30 Sep 2024
- Study completionJun 2028 (estimated)
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.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 4 arm randomized clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Manz, MD, Dana-Farber Cancer Institute
- Investigators
- Christopher Manz, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629065
- Sponsor's protocol ID
- 22-501
- Acronym
- (PATH-SIC)
- Status last verified
- Aug 2025
- First submitted
- 17 Nov 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)
- ClinicalTrials.gov ID
- NCT05629065
- Acronym / sponsor ID
- (PATH-SIC) / 22-501
- Conditions
- Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer, Genitourinary Cancer
- Keywords
- Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer, Genitourinary Cancer, Serious Illness Communication
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Nov 2022 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- 4 arm randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Both patient and clinician receive a nudge | Experimental | Other: Clinician Nudge Email, Other: Patient Nudge Letter and Share questionaire* Patient nudge consists of a letter and SHARE questionnaire * Clinician "nudge" email encouraging discussion to initiate discussion on SIC |
| Neither the patient nor clinician receive a nudge | No intervention | –Standard Care |
| Patient receives a nudge but not the clinician | Experimental | Other: Patient Nudge Letter and Share questionaire-Patient nudge consists of a letter and SHARE questionnaire |
| Clinician receives a nudge but not the patient | Experimental | Other: Clinician Nudge Email-Clinician "nudge" email encouraging discussion to initiate discussion on SIC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Clinician Nudge Email-Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit | Other | Both patient and clinician receive a nudge, Clinician receives a nudge but not the patient |
| Patient Nudge Letter and Share questionaireInvolves 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. | Other | Both patient and clinician receive a nudge, Patient receives a nudge but not the clinician |
Primary outcome
Proportion of patients with an SIC at 60 days for arm 1 (patient +clinician nudge) vs arm 2 (no nudge).
Time frame: up to 60 days after reaching the poor prognosis node
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.
12 secondary outcomes
Proportion of patients with an SIC at 60 days, comparison of all 4 study arms
Time frame: up to 60 days after reaching the poor prognosis node
Time from SIC to death among decedents
Time frame: randomization up to 1 year
Receipt of chemotherapy in last 14 days of life
Time frame: randomization up to 1 year
ED visits in the last 30 days of life
Time frame: randomization up to 1 year
Hospitalization in last 30 days of life
Time frame: randomization up to 1 year
Median length of hospitalization
Time frame: randomization up to 1 year
ICU utilization in last 30 days of life
Time frame: randomization up to 1 year
Death in an acute care facility
Time frame: randomization up to 1 year
Death in the ICU
Time frame: randomization up to 1 year
Hospice enrollment at death
Time frame: randomization up to 1 year
Enrolled < 4 days in hospice at death
Time frame: randomization up to 1 year
Patient preferences
Time frame: Up to 60 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Christopher Manz, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician Nudge Email and Patient Nudge Letter and Share questionaire in people with Breast Cancer and Gastrointestinal Cancer, run by Dana-Farber Cancer Institute 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 6 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of patients with an SIC at 60 days for arm 1 (patient +clinician nudge) vs arm 2 (no nudge). (time frame: up to 60 days after reaching the poor prognosis node). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025.