Hematopoietic and Lymphatic System NeoplasmNCT07052630
Patient Navigation and the Planning Advance Care Together Website to Improve Goals of Care Conversations in Hematopoietic Cell Transplant Survivors, IMPACT-HCT Trial
A study testing Internet-Based Intervention, Patient Navigation and Best Practice in people with Hematopoietic and Lymphatic System Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Internet-Based Intervention, Patient Navigation and Best Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Unable to provide informed consent
- Uncontrolled psychiatric conditions (confirmed through electronic health record [EHR] by study staff)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Megan Shen, PhD, 206-667-4172, mshen2@fredhutch.org
Megan Shen, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- Internet-Based Intervention, Patient Navigation, Best Practice, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Interact with PACT website
Patient NavigationBehavioural
Also called Patient Navigator Program
Receive a patient navigation session
Best PracticeOther
Also called standard of care, standard therapy
Receive standard/usual care
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Patient Navigation; Other: Survey Administration |
| Condition 3 (PACT) | Experimental | Patients interact with the PACT website over 4 weeks. Receives: Other: Internet-Based Intervention; Other: Survey Administration |
| Condition 4 (standard/usual care) | Active comparator | Patients receive standard/usual care for 4 weeks on study. Receives: Other: Best Practice; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, and at 4 and 12 weeks post intervention
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start21 Oct 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Shen, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052630
- Sponsor's protocol ID
- RG1125595
- Other IDs
- NCI-2025-04134, 20855
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Goals of Care Conversations With Hematopoietic Cell Transplant Survivors (IMPACT - HCT)
- ClinicalTrials.gov ID
- NCT07052630
- Acronym / sponsor ID
- RG1125595
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Condition 1 (PACT, patient navigation) | Experimental | Other: Internet-Based Intervention, Behavioral: Patient Navigation, Other: Survey AdministrationPatients 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) | Experimental | Behavioral: Patient Navigation, Other: Survey AdministrationPatients receive a navigation session over 45-60 minutes with a trained health coach to review ACP. |
| Condition 3 (PACT) | Experimental | Other: Internet-Based Intervention, Other: Survey AdministrationPatients interact with the PACT website over 4 weeks. |
| Condition 4 (standard/usual care) | Active comparator | Other: Best Practice, Other: Survey AdministrationPatients receive standard/usual care for 4 weeks on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Uncontrolled psychiatric conditions (confirmed through electronic health record [EHR] by study staff)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionInteract with PACT website | Other | Condition 1 (PACT, patient navigation), Condition 3 (PACT) |
| Patient NavigationAlso: Patient Navigator ProgramReceive a patient navigation session | Behavioural | Condition 1 (PACT, patient navigation), Condition 2 (patient navigation) |
| Best PracticeAlso: standard of care, standard therapyReceive standard/usual care | Other | Condition 4 (standard/usual care) |
| Survey AdministrationAncillary studies | Other | Condition 1 (PACT, patient navigation), Condition 2 (patient navigation), Condition 3 (PACT), Condition 4 (standard/usual care) |
Primary outcome
Feasibility (Rate of enrollment)
Time frame: 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.
Feasibility (Rate of completion of intervention components)
Time frame: 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)
Time frame: 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.
Acceptability of intervention
Time frame: 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.
Completion of advance directives
Time frame: 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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Shen, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Patient Navigation and Best Practice in people with Hematopoietic and Lymphatic System Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Shen, PhD (206-667-4172, mshen2@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Rate of enrollment) (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.