NCT06955468

Brief Summary

This pilot study will evaluate whether an intervention aimed at hospitalized patients with advanced lung and gastrointestinal cancers can help facilitate goals-of-care (GOC) communication with their oncologists after discharge. While GOC communication is a recommended component of routine oncology care, many patients with solid cancers do not have the opportunity to talk with their oncologist about their goals and end-of-life preferences. Prior research has shown that a systematic method of prompting GOC communication with at-risk patients would address a key barrier to timely GOC communication and ensure that patients receive care that is in line with their personal preferences. This trial will enroll 80 participants, who will be randomized 1:1 to either an intervention or a control group. Participants in the intervention group will complete a short survey regarding their goals, preferences, and disease understanding. Survey responses will be shared with each participant's outpatient oncology team. Oncologists will subsequently receive a nudge in the electronic medical record reminding them of key survey responses and encouraging them to discuss them at the patient's first clinic visit after hospital discharge. The primary feasibility outcome is intervention completion rate and the primary clinical outcome is GOC documentation within 30 days of discharge in the intervention group compared to the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 21, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

April 25, 2025

Last Update Submit

March 3, 2026

Conditions

Keywords

Communication

Outcome Measures

Primary Outcomes (2)

  • Intervention Completion Rate

    The primary feasibility outcome is intervention completion rate, defined as successful completion of the survey, response sharing, and electronic medical record nudge for all participants assigned to the intervention arm.

    From enrollment to 30 days after hospital discharge

  • GOC Documentation

    The presence of outpatient goals-of-care documentation in the electronic medical record within 30 days of hospital discharge as determined by manual review.

    From enrollment to 30 days after hospital discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention arm will complete a survey prior to hospital discharge. Their responses will be shared with each participant's outpatient oncology team.

Behavioral: Priming Survey

Control

NO INTERVENTION

Interventions

Priming SurveyBEHAVIORAL

13-item priming survey assessing patients' goals, treatment preferences, and disease understanding.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unplanned admission to the HUP Solid Oncology service;
  • Underlying diagnosis of advanced lung or GI cancer, defined as metastatic or locally advanced disease;
  • Anticipated discharge within the next 72h; and
  • Primary oncologist is based at HUP; or
  • Family member/caregiver of a patient meeting the above 4 criteria.

You may not qualify if:

  • \. Unable to complete survey in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsGastrointestinal NeoplasmsCommunication

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2025

First Posted

May 2, 2025

Study Start

July 21, 2025

Primary Completion

January 26, 2026

Study Completion

March 1, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations