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Recruiting NCT07052630

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

No phase Interventional Hematopoietic and Lymphatic System Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet-Based Intervention, Patient Navigation, Best Practice, Survey Administration.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphatic System Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Other Internet-Based Intervention
    Interact with PACT website
  • Behavioral Patient Navigation
    Receive a patient navigation session
  • Other Best Practice
    Receive standard/usual care
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Feasibility (Rate of enrollment) [Time frame: At baseline]
  • Feasibility (Rate of completion of intervention components) [Time frame: At 12 weeks post intervention]
  • Feasibility (Rate of completion of study assessments) [Time frame: At baseline, and at 4 and 12 weeks post intervention]
  • Acceptability of intervention [Time frame: At 4 weeks post intervention]
  • Completion of advance directives [Time frame: At baseline, and at 4 and 12 weeks post intervention]
Secondary outcome measures (7)
  • Discussion of advance care planning (ACP)/goals of care conversation [Time frame: At baseline, and at 4 and 12 weeks post intervention]
  • Level of engagement in ACP [Time frame: At baseline, and at 4 and 12 weeks post intervention]
  • Readiness to engage in ACP [Time frame: At baseline, and at 4 and 12 weeks post intervention]
  • Self-efficacy for treatment decision-making [Time frame: At baseline, and at 4 and 12 weeks post intervention]
  • Psychological distress [Time frame: At baseline, and at 4 and 12 weeks post intervention]
  • Engagement with PACT website [Time frame: At baseline, and at 4 and 12 weeks post intervention]
  • Engagement with patient navigation intervention (Completion rates of patient navigation intervention session) [Time frame: At 4 weeks post intervention]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT07052630 · RG1125595 · NCI-2025-04134 · 20855

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗