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

NCT07052630 | Recruiting

• 3 other identifiers: RG1125595NCI-2025-0413420855
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Discussion of advance care planning (ACP)/goals of care conversation

  At baseline, and at 4 and 12 weeks post intervention

• Level of engagement in ACP

  At baseline, and at 4 and 12 weeks post intervention

• Readiness to engage in ACP

  At baseline, and at 4 and 12 weeks post intervention

• Self-efficacy for treatment decision-making

  At baseline, and at 4 and 12 weeks post intervention

• Psychological distress

  At baseline, and at 4 and 12 weeks post intervention

Study Arms (4)

Condition 1 (PACT, patient navigation)

EXPERIMENTAL

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: Internet-Based Intervention; Behavioral: Patient Navigation; Other: Survey Administration

Condition 2 (patient navigation)

EXPERIMENTAL

Patients receive a navigation session over 45-60 minutes with a trained health coach to review ACP.

Behavioral: Patient Navigation; Other: Survey Administration

Condition 3 (PACT)

EXPERIMENTAL

Patients interact with the PACT website over 4 weeks.

Other: Internet-Based Intervention; Other: Survey Administration

Condition 4 (standard/usual care)

ACTIVE COMPARATOR

Patients receive standard/usual care for 4 weeks on study.

Other: Best Practice; Other: Survey Administration

Interventions

Internet-Based Intervention OTHER

Interact with PACT website

Condition 1 (PACT, patient navigation); Condition 3 (PACT)

Patient Navigation BEHAVIORAL

Receive a patient navigation session

Also known as: Patient Navigator Program

Condition 1 (PACT, patient navigation); Condition 2 (patient navigation)

Best Practice OTHER

Receive standard/usual care

Also known as: standard of care, standard therapy

Condition 4 (standard/usual care)

Survey Administration OTHER

Ancillary studies

Condition 1 (PACT, patient navigation); Condition 2 (patient navigation); Condition 3 (PACT); Condition 4 (standard/usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Interventions

Patient Navigation; Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Megan Shen, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Shen, PhD

CONTACT

206-667-4172; mshen2@fredhutch.org

Study Design

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

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 4, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)