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OpenTrials
Active, Not Recruiting

NCT Number: NCT05629065

Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genitourinary Cancer Gynecologic Cancer Male Urogenital Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Thoracic Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clinician Nudge Email

Other

-Clinician "nudge" email encouraging discussion to initiate discussion on SIC at next visit

Patient Nudge Letter and Share questionaire

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    Same as the primary outcome

  2. Time from SIC to death among decedents

    Time frame: randomization up to 1 year

    Time from SIC to death among decedents

  3. Receipt of chemotherapy in last 14 days of life

    Time frame: randomization up to 1 year

    Whether or not the patient received chemotherapy in the last 14 days of life, among decedents

  4. ED visits in the last 30 days of life

    Time frame: randomization up to 1 year

    Number of ED visits in the last 30 days of life, among decedents

  5. Hospitalization in last 30 days of life

    Time frame: randomization up to 1 year

    Hospitalization in the last 30 days of life, among decedents

  6. Median length of hospitalization

    Time frame: randomization up to 1 year

    Median length of last hospitalization, in days among decedents

  7. ICU utilization in last 30 days of life

    Time frame: randomization up to 1 year

    ICU hospitalization in the last 30 days of life, among decedents

  8. Death in an acute care facility

    Time frame: randomization up to 1 year

    Presence or absence of death in an acute care facility like a hospital or emergency room

  9. Death in the ICU

    Time frame: randomization up to 1 year

    Whether or not death occurred in an ICU

  10. Hospice enrollment at death

    Time frame: randomization up to 1 year

    Whether or not the patient was enrolled in hospice on the day of death

  11. Enrolled < 4 days in hospice at death

    Time frame: randomization up to 1 year

    Whether or not the patient was enrolled in hospice for less than 4 days on the day of death

  12. Patient preferences

    Time frame: Up to 60 days after randomization

    Patient responses on SHARE questionnaire

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Acronym: (PATH-SIC)

Important dates

Study start
2022
Primary completion
2024
Study completion
2028
First posted
Nov 29, 2022
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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