Bone Marrow TransplantNCT03758911
Perspectives on Bone Marrow Donors Who Donate for Their Parent
An observational study of Bone Marrow Transplant, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Trial summary
The purpose of this pilot study is to explore the role of family function on decision-making for bone marrow donors who donated for their parent, and to assess the unique supportive care needs of these participants. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Marrow Transplant
- What is being tested?
- Semi-structured Interview
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2016to 29 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants included adolescents, young adults, or adults who had donated bone marrow or peripheral blood stem cells for their parent in the past 1 - 6 months.
Who may be able to join
- Donated bone marrow or peripheral blood stem cells for their parent in the past 1-6 months
- Willing to participate in mandatory audio recorded telephone interview
- Able to participate in interview without assistance
- Must be English speaking
- Transplant recipient (parent) must be living
Who cannot join
- Unable to provide oral consent for participation (for minors- unable to obtain parental consent and/or oral assent from child for participation)
About this study
Official title: Perspectives on the Adolescent, Young Adult, and Adult Experience as Donors for Their Parent Undergoing Haploidentical Bone Marrow Transplants
The purpose of this pilot study is to explore the role of family function on decision-making for bone marrow donors who donated for their parent, and to assess the unique supportive care needs of these participants. Semi-structured interviews were conducted with participants to identify overarching themes of the donation experience.
- Conditions
- Bone Marrow Transplant
- Being tested
- Semi-structured Interview
- Keywords
- bone marrow, stem cell, donor, interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured InterviewOther
| Study group | Role | What they receive |
|---|---|---|
| bone marrow/blood stem cell donors | Participants underwent a one time semi-structured telephone interview to understand the perspectives of bone marrow/stem cell donors experience, including how family dynamics impacted participants' decision to donate and identifying unique supportive care needs of bone marrow/stem cell donors. Receives: Other: Semi-structured Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes influencing donors' decision-making as assessed by words used during interview responses
Words/terms are extracted from interviewer responses and associated to key themes that influence participant's decision-making process. A codebook is used to reference these words/terms
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start6 Dec 2016
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow TransplantStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Nina D Wagner-Johnston, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758911
- Sponsor's protocol ID
- J16127
- Other IDs
- IRB00111131, 2016-03p
- Status last verified
- Nov 2018
- First submitted
- 28 Nov 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perspectives on the Adolescent, Young Adult, and Adult Experience as Donors for Their Parent Undergoing Haploidentical Bone Marrow Transplants
- ClinicalTrials.gov ID
- NCT03758911
- Acronym / sponsor ID
- J16127
- Conditions
- Bone Marrow Transplant
- Keywords
- bone marrow, stem cell, donor, interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to explore the role of family function on decision-making for bone marrow donors who donated for their parent, and to assess the unique supportive care needs of these participants. Semi-structured interviews were conducted with participants to identify overarching themes of the donation experience.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bone marrow/blood stem cell donors | – | Other: Semi-structured InterviewParticipants underwent a one time semi-structured telephone interview to understand the perspectives of bone marrow/stem cell donors experience, including how family dynamics impacted participants' decision to donate and identifying unique supportive care needs of bone marrow/stem cell donors. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants included adolescents, young adults, or adults who had donated bone marrow or peripheral blood stem cells for their parent in the past 1 - 6 months.
Key inclusion criteria (5 listed)
- Donated bone marrow or peripheral blood stem cells for their parent in the past 1-6 months
- Willing to participate in mandatory audio recorded telephone interview
- Able to participate in interview without assistance
- Must be English speaking
- Transplant recipient (parent) must be living
Key exclusion criteria (1 listed)
- Unable to provide oral consent for participation (for minors- unable to obtain parental consent and/or oral assent from child for participation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured Interview | Other | bone marrow/blood stem cell donors |
Primary outcome
Themes influencing donors' decision-making as assessed by words used during interview responses
Time frame: Day 1
Words/terms are extracted from interviewer responses and associated to key themes that influence participant's decision-making process. A codebook is used to reference these words/terms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina D Wagner-Johnston, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Transplant, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Themes influencing donors' decision-making as assessed by words used during interview responses (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.