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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unable to provide informed consent

Uncontrolled psychiatric conditions (confirmed through electronic health record [EHR] by study staff)

Trial design

Design model

Factorial

Treatments tested in this trial

  • Internet-Based Intervention

    Other intervention

    Interact with PACT website

  • Patient Navigation

    Behavioral

    Receive a patient navigation session

  • Best Practice

    Other intervention

    Receive standard/usual care

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Condition 1 (PACT, patient navigation)Experimental treatment 3 interventions
Group B: Condition 2 (patient navigation)Experimental treatment 2 interventions
Group C: Condition 3 (PACT)Experimental treatment 2 interventions
Group D: Condition 4 (standard/usual care)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline
2

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.

Time frame
At 12 weeks post intervention
3

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.

Time frame
At baseline, and at 4 and 12 weeks post intervention
4

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.

Time frame
At 4 weeks post intervention

Secondary outcomes

1

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.

Time frame
At baseline, and at 4 and 12 weeks post intervention
2

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.

Time frame
At baseline, and at 4 and 12 weeks post intervention
3

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.

Time frame
At baseline, and at 4 and 12 weeks post intervention
4

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.

Time frame
At baseline, and at 4 and 12 weeks post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.