Improving Goals of Care Conversations With Hematopoietic Cell Transplant Survivors (IMPACT - HCT)
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 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.
Arms & interventions
- OtherInternet-Based Intervention
Interact with PACT website
- BehavioralPatient Navigation
Receive a patient navigation session
- OtherBest Practice
Receive standard/usual care
- OtherSurvey Administration
Ancillary studies
Outcome measures
Primary
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
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
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
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
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.
Time frame: At baseline, and at 4 and 12 weeks post intervention
Secondary
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
Study locations (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109