Patient Navigation and the Planning Advance Care Together Website to Improve Goals of Care Conversations in Hematopoietic Cell Transplant Survivors, IMPACT-HCT Trial

Improving Goals of Care Conversations With Hematopoietic Cell Transplant Survivors (IMPACT - HCT)

This clinical trial evaluates the impact of patient navigation and the Planning Advance Care Together (PACT) website, either alone or in combination with one another, on advanced care planning (ACP) in patients with blood cancers who received a hematopoietic cell transplant (HCT). Engagement in ACP, including having goals of care conversations, improves quality of care at the end of life and supporting this should be included in all cancer survivorship care. Patient navigation is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening follow-up, diagnosis, treatment, and supportive care. PACT is a web-based tool that provides information about ACP, assistance with documents for advanced directives, a supportive network and a forum for discussions about ACP. Patients who engage in ACP are more likely to have higher quality of life at the end of life, receive the care they want, die where they prefer, utilize hospice effectively, and are less likely to receive futile, aggressive care at the end of life. For HCT survivors at ongoing risk of death and other disease-related complications, having a plan in place for care they want is critical. Patient navigation and/or the PACT website may improve ACP, including completion of advance care directives and goals of care conversations, in patients with blood cancers who received an HCT.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Internet-Based Intervention; Behavioral: Patient Navigation; Other: Best Practice

Detailed Description

OUTLINE: Patients are randomized to 1 of 4 conditions.

CONDITION 1 (PACT + PATIENT NAVIGATION): Patients interact with the PACT website over 4 weeks and receive a navigation session over 45-60 minutes with a trained health coach to review ACP.

CONDITION 2 (PATIENT NAVIGATION ONLY): Patients receive a navigation session over 45-60 minutes with a trained health coach to review ACP.

CONDITION 3 (PACT ONLY): Patients interact with the PACT website over 4 weeks.

CONDITION 4 (NO PACT/NO PATIENT NAVIGATION): Patients receive standard/usual care for 4 weeks on study.

After completion of study intervention, patients are followed up at 4 and 12 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Shen, PhD; Phone Number: 206-667-4172; Email: mshen2@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Megan Shen, PhD; Phone Number: 206-667-4172; Email: mshen2@fredhutch.org
      • Principal Investigator: Megan Shen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Received a transplant for a hematologic malignancy
• Current age 18 years of age or older
• Currently 1 to 5 years after HCT
• Ability to speak and read English
• Has not completed all advance directives and/or had a goals of care (GOC) conversation with their physician
• Access to the internet (via computer, tablet, or mobile device)

Exclusion Criteria:

• Unable to provide informed consent
• Uncontrolled psychiatric conditions (confirmed through electronic health record [EHR] by study staff)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Condition 3 (PACT); Patients interact with the PACT website over 4 weeks.	Other: Survey Administration; Ancillary studies; Other: Internet-Based Intervention; Interact with PACT website
Active Comparator: Condition 4 (standard/usual care); Patients receive standard/usual care for 4 weeks on study.	Other: Survey Administration; Ancillary studies; Other: Best Practice; Receive standard/usual care; Other Names: standard of care; standard therapy
Experimental: Condition 1 (PACT, patient navigation); Patients interact with the PACT website over 4 weeks and receive a navigation session over 45-60 minutes with a trained health coach to review ACP.	Other: Survey Administration; Ancillary studies; Other: Internet-Based Intervention; Interact with PACT website; Behavioral: Patient Navigation; Receive a patient navigation session; Other Names: Patient Navigator Program
Experimental: Condition 2 (patient navigation); Patients receive a navigation session over 45-60 minutes with a trained health coach to review ACP.	Other: Survey Administration; Ancillary studies; Behavioral: Patient Navigation; Receive a patient navigation session; Other Names: Patient Navigator Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (Rate of enrollment)	Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. Feasibility cutoffs will be based on prior research and include >= 50% of eligible patients will enroll in the study.	At baseline
Feasibility (Rate of completion of intervention components)	For the patient navigation component, this means that patients participate in the single patient navigation session with a health coach. For the Planning Advance Care Together (PACT) condition, this means that patients set up an account with the PACT website and engage in at least accessing the website. Feasibility cutoffs will be based on prior research and include >= 50% of enrolled patients will adhere to and complete assigned intervention components and study-related assessments.	At 12 weeks post intervention
Feasibility (Rate of completion of study assessments)	Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. Feasibility cutoffs will be based on prior research and include >= 50% of enrolled patients will adhere to and complete assigned intervention components and study-related assessments.	At baseline, and at 4 and 12 weeks post intervention
Acceptability of intervention	Will be measured using the 4-item Acceptability of Intervention Measure. Items are rated on a 5-point Likert scale. Acceptability will be defined as a median score of >= 4.	At 4 weeks post intervention
Completion of advance directives	Questions asking patients whether they have completed a do not resuscitate (DNR) order, living will or identified a health care proxy. This item is scored as having no advance directives (0) to all advance directives completed (3). In addition to the primary outcome of advance directives (0 to 3 score), investigators will also examine each outcome separately (e.g., yes/no to completing a health care proxy) as secondary measures.	At baseline, and at 4 and 12 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discussion of advance care planning (ACP)/goals of care conversation	Will be measured using the 8-item measure of discussing end-of-life care, living will, health care proxy and do not resuscitate (DNR) orders with family and doctor. Will be evaluated using a linear mixed model with effect coding.	At baseline, and at 4 and 12 weeks post intervention
Level of engagement in ACP	Will be measured using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. It is an 18-item measure assessing domains of decision maker, quality of life, flexibility, and asking questions about treatment and ACP (yes/no). Will be evaluated using a linear mixed model with effect coding.	At baseline, and at 4 and 12 weeks post intervention
Readiness to engage in ACP	Will be assessed using a previously developed and validated questionnaire, the Advance Care Planning Readiness Scale. This is an 8-item questionnaire that asks questions about patients' readiness to engage in ACP on a 7-point Likert scale (1 = Strongly disagree, 7 = Strongly agree). Will be evaluated using a linear mixed model with effect coding.	At baseline, and at 4 and 12 weeks post intervention
Self-efficacy for treatment decision-making	Will be measured by the Decision-Making Participation Self-Efficacy (DEPS) scale. The DEPS scale is a 5-item validated measure that assesses cancer patients' confidence in engaging in different activities related to decision-making. Patients are asked to indicate how confident they are that they would be able to engage in various decision-making activities (e.g., "Tell your doctor about the option you would prefer"); items are rated on a 5-point Likert scale (1 = not at all confident, 5 = completely confident). Will be evaluated using a linear mixed model with effect coding.	At baseline, and at 4 and 12 weeks post intervention
Psychological distress	Will be measured using the Patient Health Questionnaire, an 8-item questionnaire assessing depression on a 4-point Likert scale (0 = not at all, 3 = nearly every day). Will be evaluated using a linear mixed model with effect coding.	At baseline, and at 4 and 12 weeks post intervention
Engagement with PACT website	Will be assessed by capturing data to indicate the engagement levels with the PACT website for those randomly assigned to this component, including: number and frequency of visits to the website and time spent on each component of the website.	At baseline, and at 4 and 12 weeks post intervention
Engagement with patient navigation intervention (Completion rates of patient navigation intervention session)	Will assess engagement with the patient navigation component for those randomly assigned to this component by tracking completion rates of the single, one time patient navigation session.	At 4 weeks post intervention

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Megan Shen, PhD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: June 24, 2025
• First Submitted That Met QC Criteria: July 1, 2025
• First Posted (Actual): July 4, 2025

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Standard of Care; Practice Guidelines as Topic; Patient Navigation
• Other Study ID Numbers: RG1125595; 20855 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2025-04134 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No