Motivations, Expectations, and Decision-making of Sickle Cell Patients in Clinical Research (NCT03709303) | Clinical Trial Compass
CompletedNot Applicable
Motivations, Expectations, and Decision-making of Sickle Cell Patients in Clinical Research
United States27 participantsStarted 2018-10-29
Plain-language summary
Background:
Sickle cell disease is an inherited blood disorder. People with this disease have a problem with their hemoglobin. That is a protein in red blood cells that carries oxygen in the body. Some people with this disease are enrolled in research at NIH. Researchers want to learn more about the thoughts and opinions of those people. This may improve the way researchers explain clinical studies, risks, and benefits to people with the disease.
Objective:
To learn about the motivations, decisions, and experiences in clinical research of people with sickle cell disease.
Eligibility:
Adults ages 18 and older who have sickle cell disease. They must be in an NIH study on this condition. They must have been invited to join either a gene therapy or peripheral blood stem cell transplantation study.
Design:
Participants will have 1 interview. It will be done in a quiet room in the NIH Clinical Center or by video call. It will take about 60 minutes.
The interview will be audio-recorded if the participant agrees.
Participants will be asked about:
* Their experiences with and thoughts on sickle cell disease
* Their decision to participate in clinical research
* Factors that may have affected their decision to participate. These may include family, disease history, or faith.
Participants may complete a few brief questionnaires.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Our inclusion criteria for study subjects are:
* Adult (18+ years and older)
* Sickle cell disease patients who are enrolled in at least one of the following sickle cell disease protocols at the National Institutes of Health, National Heart, Lung, and Blood Disease:
* Screening study: 08-H-0156
* Natural history protocol: 04-H-0161
* PBSCT: 09-H-0225, 17-H-0069, 14-H-0077, 03-H-0170
* GT: 14-H-0155
* Have made a decision regarding participation in one of the GT or PBSCT protocols (e.g. someone could still be enrolled in Screening study, have made a decision, but not yet enrolled in or have declined enrollment in the GT or PBSCT studies)
* Study subjects will be recruited in two groups: 1) pre-transplant or pre-initiation of gene therapy, including both those who decide to enroll and those who declined to enroll; and 2) post-transplantation or post-GT, including those who had an unsuccessful and those who had a successful transplantation or response to GT.
EXCLUSION CRITERIA:
Study subjects will be excluded if they:
* Lack cognitive capacity
* Are not English speaking
* Have not made a decision about participation in one of the GT or PBSCT protocols for which they are eligible
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Expectations, understanding and motivations for enrollment
Timeframe: Before or after enrollment in PBSCT or GT trial, but after decision made
Trial details
NCT IDNCT03709303
SponsorNational Institutes of Health Clinical Center (CC)