Protocol Details
Understanding the Patient Experience: Symptom Burden in Pediatric Patients Receiving Chimeric Antigen Receptor (CAR) T-cell Therapy
This study is NOT currently recruiting participants.
Summary
Number | 000067-C |
Sponsoring Institute | National Cancer Institute (NCI) |
Recruitment Detail | Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 2 Years
Max Age: N/A |
Referral Letter Required | No |
Population Exclusion(s) | Neonates |
Keywords | CD-19 expressing tumor;
CD-22 Expressing Tumor;
Adaptive Immunotherapy;
Caregivers;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Acute Lymphoid Leukemia;
B-Cell Leukemia;
Lymphoma, Non-Hodgkin;
Neoplasms;
B-Cell Lymphoma |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Cancer Institute |
Background:
Doctors want to learn more about what it is like to receive CAR T-cell cancer therapy. Most of what they know comes from what a person s doctors or nurses report about their symptoms. Researchers think that this may not fully describe what this treatment is like for people and their families. They want to help people and their families know what to expect when they go through treatment with CAR T-cells.
Objective:
To better understand what it is like for young people to be treated with CAR T-cell therapies.
Eligibility:
People ages 8 to 25 or caregivers of a child aged 2 to 25 who will be treated with CAR T-cell therapy at the National Cancer Institute - Pediatric Oncology Branch.
Design:
Participants will be screened with a review of their medical records.
Participants will be enrolled on the CAR T PROs study. This will include up to 10 surveys. The surveys will take 10 to 30 minutes each. It will also include one interview. The interview will take about 30 to 60 minutes. Surveys can be done on paper or an electronic version using a secure survey tool.
For caregivers, surveys will be completed by one caregiver at each time point. The
interview is open to both caregivers, if this applies.
During the study, participants might have to go to the hospital for side effects of the CAR T-cell therapy. If this happens, they may be asked to complete another survey at that time.
Interviews with participants will be audiotaped or digitally recorded.
Participants will be in the study for one year.
Eligibility
Eligibility: - Patient Participants ages 2-25 years old
-- Any cancer diagnosis
-- Scheduled to receive CAR T cell therapy
- Caregiver Participants
-- Primary caregiver of a patient 2 to 25 years who is scheduled to receive CAR T cell therapy
- Speak and read English or Spanish
Citations:
Not Provided
Contacts: