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

NCT ID: NCT07052630

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-21

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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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 30-45 minutes with a trained health coach to review ACP.

CONDITION 2 (PATIENT NAVIGATION ONLY): Patients receive a navigation session over 30-45 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.

Conditions

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Hematopoietic and Lymphatic System Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Condition 1 (PACT, patient navigation)

Patients interact with the PACT website over 4 weeks and receive a navigation session over 30-45 minutes with a trained health coach to review ACP.

Group Type EXPERIMENTAL

Internet-Based Intervention

Intervention Type OTHER

Interact with PACT website

Patient Navigation

Intervention Type BEHAVIORAL

Receive a patient navigation session

Survey Administration

Intervention Type OTHER

Ancillary studies

Condition 2 (patient navigation)

Patients receive a navigation session over 30-45 minutes with a trained health coach to review ACP.

Group Type EXPERIMENTAL

Patient Navigation

Intervention Type BEHAVIORAL

Receive a patient navigation session

Survey Administration

Intervention Type OTHER

Ancillary studies

Condition 3 (PACT)

Patients interact with the PACT website over 4 weeks.

Group Type EXPERIMENTAL

Internet-Based Intervention

Intervention Type OTHER

Interact with PACT website

Survey Administration

Intervention Type OTHER

Ancillary studies

Condition 4 (standard/usual care)

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

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard/usual care

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Internet-Based Intervention

Interact with PACT website

Intervention Type OTHER

Patient Navigation

Receive a patient navigation session

Intervention Type BEHAVIORAL

Best Practice

Receive standard/usual care

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Patient Navigator Program standard of care standard therapy

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan Shen, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Shen, PhD

Role: CONTACT

206-667-4172

Facility Contacts

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Megan Shen, PhD

Role: primary

206-667-4172

Other Identifiers

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NCI-2025-04134

Identifier Type: REGISTRY

Identifier Source: secondary_id

20855

Identifier Type: OTHER

Identifier Source: secondary_id

RG1125595

Identifier Type: -

Identifier Source: org_study_id

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