Chimeric Antigen Receptor T-cell TherapyAPPROACHNCT07886190
Symptom Monitoring and Management Intervention After CAR-T
A study testing WAYPOINT in people with Chimeric Antigen Receptor T-cell Therapy and Hematologic Malignancy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chimeric Antigen Receptor T-cell Therapy, Hematologic Malignancy
- What is being tested?
- WAYPOINT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 30 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daniella Landau contact
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Anna Barata, PhD, 617-724-4000, ABARATA@MGH.HARVARD.EDU
About this study
Official title: Improving Patient Outcomes Through a Digital Health Delivered Intervention to Monitor and Manage Symptoms After Chimeric Antigen Receptor T-Cell Therapy
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).
Read the detailed description
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.
- Being tested
- WAYPOINT
- Keywords
- hematologic malignancy, hematologic diseases, neoplasms, hematologic neoplasms, quality of life
- Medical subject headings
- Hematologic Neoplasms, Hematologic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAYPOINTBehavioural
Digital symptom monitoring and management intervention that includes psychoeducation and symptom monitoring, with alerts to the clinical team.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: WAYPOINT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 90 days post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Mar 2027 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chimeric Antigen Receptor T-cell TherapyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ana Barata Badiella, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886190
- Sponsor's protocol ID
- 26-337
- Other IDs
- 1R41CA314618
- Acronym
- APPROACH
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.