Symptom Monitoring and Management Intervention After CAR-T

This study will examine the feasibility and acceptability of a digital symptom monitoring and management intervention (WAYPOINT) for improving symptom burden, quality of life and self-efficacy among patients treated with chimeric antigen receptor T-cell (CAR-T) therapy.

We will first refine WAYPOINT and then conduct a single-arm trial. During the refinement phase, we will enroll 15 patients and 10 clinicians to gather feedback on WAYPOINT and inform further development of the intervention. Following refinement, we will enroll 30 patients and 10 clinicians in a single arm study to examine the feasibility and acceptability of WAYPOINT for improving symptom burden, quality of life and self-efficacy after CAR-T therapy.

Participation in this study is expected to last up to 90 days after enrollment.

The National Institutes of Health is supporting this research by providing funding.

• WAYPOINT (Behavioral): Digital symptom monitoring and management intervention that includes psychoeducation and symptom monitoring, with alerts to the clinical team.

Primary outcomes

• Feasibility of the intervention: percentage of eligible patients who enroll and remain in the study by day 90 [Up to 90 days post enrollment]: The investigators will assess feasibility based on the percentage of eligible patients who enroll and the percentage of enrolled patients who remain in the study through day 90. The intervention will be considered feasible if at least 60% of eligible patients enroll and at least 70% of enrolled patients remain in the study through day 90.
• Acceptability of the intervention: percentage of participants report satisfaction when using the intervention. [Up to 90 days post-enrollment]: The investigators will assess acceptability by examining the percentage of patients and clinicians who report satisfaction with WAYPOINT. The intervention will be considered acceptable if at least 80% of patients and at least 80% of clinicians report satisfaction with WAYPOINT. For patients, a score =>20 on the 8-item Client Satisfaction Questionnaire (CSQ-8; range of scores 8-32) will indicate acceptability. For clinicians, a score => 3 on the item "How acceptable is the intervention for you" (score range, 1-5) will indicate acceptability.

Other outcomes

• Ease of use as measured by the System Usability Scale (SUS) questionnaire [Up to 90 days post enrollment]: Describe ease of use of WAYPOINT as measured by the SUS. The SUS ranges from 0-100 and higher scores indicate greater ease of use.
• Symptom burden as measured by the Edmonton Symptom Assessment Scale-revised (ESAS-r) questionnaire [Up to 90 days post enrollment]: Describe patient symptom burden as measured by the ESAS-r. The ESAS-r ranges from 0-100 and higher scores indicate worse symptom burden.
• Depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression) [Up to 90 days post enrollment]: Describe patient depression symptoms as measured by the HADS-Depression. The HADS-Depression ranges from 0-21 and higher scores indicate worse depressive symptoms
• Anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Anxiety) [Up to 90 days post enrollment]: Describe patient anxiety symptoms as measured by the HADS-Anxiety. The HADS-Anxiety ranges from 0-21 and higher scores indicate worse anxiety symptoms
• Self-efficacy as measured by the Cancer self-efficacy (CASE) scale [Up to 90 days post enrollment]: Describe patient self-efficacy as measured by the CASE. The CASE ranges from 0-170 and higher scores indicate better self-efficacy
• Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire [Up to 90 days post enrollment]: Describe patient QOL as measured by the FACT-G. The FACT-G ranges from 0-108 and higher scores indicate better QOL

Sex: All, ages: 18 Years to any

Patient Inclusion Criteria:

* Adult patients (at least 18 years old) diagnosed with hematological cancer
* Treated with CAR-T as standard of care at Massachusetts General Hospital
* Ability to speak and read English to use WAYPOINT and respond to the questionnaires with minimal assistance requried from an interpreter or a family member

Patient Exclusion Criteria:

* Patients with a major untreated psychiatric or cognitive conditions which the treating clinician believe prohibits the ability to participate in study procedures

Clinician Inclusion Criteria - Healthcare clinicians (e.g., physicians, nurses, advanced practice professionals) at the Massachusetts General Hospital who provide care for patients treated with CAR-T therapy

Clinician Exclusion Criteria

\- Not able to provide consent

NIH grants: R41CA314618