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

Not Applicable

Not yet recruiting

• Conditions: Hematopoietic and Lymphatic System Neoplasm

• Registration Number: NCT07052630
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

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 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.

Study Timeline

• Study First Submitted: 2025-06-24
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Study Start: 2025-12-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Feasibility (Rate of enrollment)	At baseline	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.
Acceptability of intervention	At 4 weeks post 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.
Feasibility (Rate of completion of intervention components)	At 12 weeks post intervention	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.
Feasibility (Rate of completion of study assessments)	At baseline, and at 4 and 12 weeks post intervention	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.
Completion of advance directives	At baseline, and at 4 and 12 weeks post intervention	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.

Secondary Outcome Measures

Name	Time	Method
Engagement with PACT website	At baseline, and at 4 and 12 weeks post intervention	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.
Discussion of advance care planning (ACP)/goals of care conversation	At baseline, and at 4 and 12 weeks post intervention	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.
Readiness to engage in ACP	At baseline, and at 4 and 12 weeks post intervention	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.
Level of engagement in ACP	At baseline, and at 4 and 12 weeks post intervention	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.
Self-efficacy for treatment decision-making	At baseline, and at 4 and 12 weeks post intervention	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.
Psychological distress	At baseline, and at 4 and 12 weeks post intervention	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.
Engagement with patient navigation intervention (Completion rates of patient navigation intervention session)	At 4 weeks post intervention	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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States