Protocol Details
Exploring the Role of Palliative Care in Phase 1 Enrolled Pediatric Oncology Patients
This study is NOT currently recruiting participants.
Summary
Number |
001092-C |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Keywords |
Palliative Care;
Pediatric Oncology Patients;
Caregiver;
Phase I Studies;
Associated Distress;
Hopes;
Worries;
Natural History |
Recruitment Keyword(s) |
None |
Condition(s) |
Quality of Life |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Cancer Institute |
Background:
About 15,000 children are diagnosed with cancer each year. Nearly 1 in 5 will die. Researchers are working hard to find better treatments. But testing new treatments in children raises ethical questions. Phase 1 clinical trials are the first step in testing new treatments in people. These early trials typically aim to test safety, with unclear knowledge of whether the treatment will work, and as such, offer only a limited chance of curing disease. This study aims to understand more about how families make the decision to enroll seriously ill children with cancer on a Phase 1 clinical trial.
Objective: To understand the experience, hopes and worries of parents who enroll their children in phase 1 clinical trials for cancer. This study will also look into how palliative care, meaning care aimed at the relief of suffering, could help these families.
Eligibility: Parents of children with cancer enrolled in phase 1 clinical trials.
Design:
Participants will have one interview. It will be held in person, over the phone, or via WebEx/Zoom (audio only). The interview is expected to last 30 to 60 minutes. It will be audio-recorded. It will not be videotaped.
Participants will answer up to 10 questions. They will be asked about the emotions they felt as they were deciding to enroll their child in the clinical trial.
The interview will be transcribed. Researchers who review the interviews will not see participants names.
Eligibility
INCLUSION CRITERIA:
-Caregiver is 18 years of age or older
-Caregiver is related to the patient in one of the following ways: biological parent, stepparent, or primary legal guardian
-If more than 1 set of parents are involved in the patient s care (e.g., 2 biologic and 2 stepparents or partners) involved, the caregiver with legal decision- making responsibilities will be eligible for participation
-Caregiver is comfortable speaking and reading English
EXCLUSION CRITERIA:
-Those who do not meet inclusion criteria.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT05412563