Symptom Monitoring and Management Intervention After CAR-T

NCT07886190 | Not Yet Recruiting

• 2 other identifiers: 26-3371R41CA314618
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chimeric Antigen Receptor T-cell Therapy; Hematologic Malignancy

Keywords

hematologic malignancy; hematologic diseases; neoplasms; hematologic neoplasms; quality of life

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 90 days post-enrollment

Other Outcomes (6)

• Ease of use as measured by the System Usability Scale (SUS) questionnaire

  Up to 90 days post enrollment

• Symptom burden as measured by the Edmonton Symptom Assessment Scale-revised (ESAS-r) questionnaire

  Up to 90 days post enrollment

• Depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)

  Up to 90 days post enrollment

Study Arms (1)

Symptom monitoring and management intervention (WAYPOINT)

EXPERIMENTAL

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

Interventions

WAYPOINT BEHAVIORAL

Digital symptom monitoring and management intervention that includes psychoeducation and symptom monitoring, with alerts to the clinical team.

Symptom monitoring and management intervention (WAYPOINT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with a major untreated psychiatric or cognitive conditions which the treating clinician believe prohibits the ability to participate in study procedures
• \- Not able to provide consent

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Hematologic Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hemic and Lymphatic Diseases

Central Study Contacts

Anna Barata, PhD

CONTACT

617-721-4000; ABARATA@MGH.HARVARD.EDU

Daniella Landau

CONTACT

dlandau@arches.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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

Locations

US (1)