An interventional study of WAYPOINT in Chimeric Antigen Receptor T-cell Therapy and Hematologic Malignancy, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
The goal of this study is to refine and test a digital intervention named WAYPOINT to help patients monitor and manage symptoms after CAR-T therapy. The main question this study aims to answer is whether this intervention can be used as planned (i.e, feasible) and whether it is helpful and easy to use for both patients and clinicians (i.e., acceptable).
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.
The investigators will first refine WAYPOINT and then conduct a single-arm trial. During the refinement phase, 15 patients and 10 clinicians will provide feedback on WAYPOINT and inform further development of the intervention. Following refinement, a single arm trial involving 30 patients and 10 clinicians will evaluate 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.
1,494 studies on the registry are indexed under Hematologic Neoplasms; 438 are open to participants now.
This study's planned enrollment of 65 is above the median of 45 across 1,090 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
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
Participants will complete the following: * Questionnaires at baseline, and days 30, 60 and 90 after enrollment * Receive the WAYPOINT intervention from enrollment through 90 days. WAYPOINT includes three components: 1) psychoeducation, 2) symptom monitoring, and 3) symptom management. The intervention includes eight modules that provide psychoeducation about common symptoms often experienced by CAR-T recipients following treatment. Participants will report their symptoms twice a week and when new symptoms occur. Based on symptom severity, WAYPOINT will provide appropriate symptom management. Participants reporting mild symptoms will receive self-management education, whereas those reporting moderate-to-severe or worsening symptoms will generate an alert to the clinical team. * Receive usual care as determined by their clinicians
Behavioral: WAYPOINT
Digital symptom monitoring and management intervention that includes psychoeducation and symptom monitoring, with alerts to the clinical team.
Feasibility of the intervention: percentage of eligible patients who enroll and remain in the study by day 90
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.
Time frame: Up to 90 days post enrollment
Acceptability of the intervention: percentage of participants report satisfaction when using the intervention.
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.
Time frame: Up to 90 days post-enrollment
Ease of use of WAYPOINT as measured by the System Usability Scale (SUS) questionnaire
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.
Time frame: Up to 90 days post enrollment
Symptom burden as measured by the Edmonton Symptom Assessment Scale-revised (ESAS-r) questionnaire
Describe patient symptom burden as measured by the ESAS-r. The ESAS-r ranges from 0-100 and higher scores indicate worse symptom burden.
Time frame: Up to 90 days post enrollment
Depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)
Describe patient depression symptoms as measured by the HADS-Depression. The HADS-Depression ranges from 0-21 and higher scores indicate worse depressive symptoms
Time frame: Up to 90 days post enrollment
Anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Anxiety)
Describe patient anxiety symptoms as measured by the HADS-Anxiety. The HADS-Anxiety ranges from 0-21 and higher scores indicate worse anxiety symptoms
Time frame: Up to 90 days post enrollment
Self-efficacy as measured by the Cancer self-efficacy (CASE) scale
Describe patient self-efficacy as measured by the CASE. The CASE ranges from 0-170 and higher scores indicate better self-efficacy
Time frame: Up to 90 days post enrollment
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire
Describe patient QOL as measured by the FACT-G. The FACT-G ranges from 0-108 and higher scores indicate better QOL
Time frame: Up to 90 days post enrollment
Plan to share: Yes — The Dana-Farber / Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data can be shared no earlier than 1 year following the date of publication
Access criteria: Contact the Mass General Brigham Innovation team
Data sharing details ↗ · research.massgeneralbrigham.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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