BereavementNCT02425787
Bereaved Parent Study
An observational study of Bereavement, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Recent focus groups at St. Jude Children's Research Hospital (SJCRH) revealed several limitations in our understanding of how parents' relationships with care staff help and hinder their grief experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bereavement
- What is being tested?
- Interview and Focus Group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 21 Aug 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents who have lost a child at SJCRH and who consent to participate in the individual interviews or follow-up focus groups. Hematology/oncology Fellows at SJCRH who consent to participate in the follow up focus groups..
Who may be able to join
- Must be at least 18 years of age.
- Must be English-speaking.
- Must have had a child who received oncological treatment at SJCRH.
- The child who received treatment must have died at least 1 year prior but no more than 6 years ago, with the cause of death related to progressive cancer or cancer-related complications.
- OR
- English-speaking Hematology/oncology Fellows at SJCRH who are at least 17 years of age.
Who cannot join
- Potential participants who indicate active suicidal ideation with or without plans will be excluded from the study. Appropriate care and referral will be given as indicated.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: The Bereaved Parent Study
Recent focus groups at St. Jude Children's Research Hospital (SJCRH) revealed several limitations in our understanding of how parents' relationships with care staff help and hinder their grief experience. Additionally, there is a gap in the bereavement literature regarding the psychological effects professional caregiver relationships have on parents whose children died of cancer. To bolster our knowledge base and benefit Bereavement Care Services at SJCRH, as well as benefit other professionals by filling the gap in the literature, we have designed a qualitative study that will conduct individual interviews with bereaved parents whose children died at SJCRH.
Validation of the preliminary analyses of the initial 30 interviews will occur through new focus groups involving two separate sets of bereaved parents who will validate the findings and/or suggest additional avenues of inquiry needed to gain a more complete understanding of parental grief/bereavement experience. Additionally, focus groups with hematology/oncology fellows will obtain provider feedback on the value of these findings in their training and future role as physicians.
The initial focus group portion of this study is complete and more than 30 interviews have been conducted with bereaved parent participants. Review of those interviews revealed that very few parent participants had children who received bone marrow transplants. For this reason, we will now specifically be recruiting bereaved parent participants whose children received bone marrow transplants at St. Jude Children's Research Hospital. We will be recruiting parents of children who received haploidentical and non-haploidentical bone marrow transplants because we believe the parents of deceased children who received haploidentical bone marrow transplants may have unique bereavement experiences related to their possible roles as donors. The act of donating or not being selected to donate to a child who goes on to die from cancer and its related complications may have unique impacts on the grieving process and warrants specific investigation. We also hope to better understand how legacy building interventions are perceived and utilized by caregivers following the death of a child from cancer.
Read the detailed description
Participants who consent will engage with the principal investigator in a one-time voice-recorded interview consisting of demographic and open-ended questions. Participants can choose to conduct the interview face-to-face or over-the-phone. Completion of the interview is expected to take between 30-90 minutes. Validation focus groups are expected to take between 30-90 minutes, as well. For the legacy-building cohort, the Child Life Department will provide additional information to specify which bereaved families received legacy items, and parents will be recruited to participate in an interview centered on the legacy item questions.
PRIMARY OBJECTIVE
To conduct qualitative interviews in order to understand what helps and what hinders bereavement processes among St. Jude parents, with particular attention to how relationships with St. Jude professional care staff affect parental bereavement processes.
EXPLORATORY OBJECTIVES
To qualitatively explore the unique bereavement experiences and challenges of parents of children who have received bone marrow transplantation, and compare these experiences with those participants whose children did not receive bone marrow transplantation.
To assess for qualitative similarities among parents with similar responses on questionnaires and/or to identify between-group differences on questionnaires among parents with qualitatively similar experiences.
- Conditions
- Bereavement
- Being tested
- Interview, Focus Group
- Keywords
- Loss of a child, Grief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Also called Questions
This is a prospective study with a semi-structured in-depth qualitative interview. Interviews will be conducted by the study PI or designee. However, in order to ensure that the interviews are conducted sensitively, the first 10 interviews will be observed and supervised by a clinically credentialed St. Jude faculty member, and an additional 10% of the interviews will be observed after that.
In order to ensure that the interviewer does not lead the participant, or in turn, that the participant does not feel limited in regards to what they believe is an appropriate or desired response, the semi-structured interview questions are general and intended to produce broad responses in regards to participant experiences.
Focus GroupBehavioural
Also called Group question/answer sessions
Focus groups will be conducted with a two-fold purpose in mind:
- With bereaved parents: to validate the findings of the preliminary analyses of the initial interviews \&/or to suggest avenues of further inquiry to expand and more deeply define the grief journey of bereaved parents.
- With Hematology/Oncology Fellows: to receive input regarding the applicability and use of the findings during the training and future careers of these medical providers.
InterviewBehavioural
Also called Questions
The interview will be conducted by study team members and will center around legacy item-related questions.
| Study group | Role | What they receive |
|---|---|---|
| Parents of deceased children (no BMT) | Participants will be parents who have lost a child at St. Jude Children's Research Hospital (SJCRH). They will participate in a 60-90 minute interview.
(Not recruiting) Receives: Behavioral: Interview | |
| Parents of deceased children (haploidentical BMT) | Participants will be parents whose child died after receiving a haploidentical bone marrow transplant at St. Jude Children's Research Hospital (SJCRH), and who have not previously participated in an interview through this study. They will participate in a 30-90 minute interview. Receives: Behavioral: Interview | |
| Parents of deceased children (non-haploidentical BMT) | Participants will be parents whose child died after receiving a non-haploidentical bone marrow transplant at St. Jude Children's Research Hospital (SJCRH), and who have not previously participated in an interview through this study. They will participate in a 30-90 minute interview. Receives: Behavioral: Interview | |
| Parents of deceased children (not interviewed) | Participants will be parents who have lost a child at SJCRH, who have not previously participated in an interview through this study.They will participate in a 30-90 minute focus group. Receives: Behavioral: Focus Group | |
| Hematology/Oncology Fellows | Participants will be Hematology/Oncology Fellows at SJCRH. They will participate in a 30-90 minute focus group. Receives: Behavioral: Focus Group | |
| Legacy-Building | Participants will be parents who have lost a child at SJCRH and received legacy items. They will participate in a 30-90 minute interview. Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive accounts of bereavement
Qualitative data will be collected using a standardized semi-structured interview technique. Researchers will analyze transcripts for content to gain a better understanding of the bereavement experience. Thematic saturation will occur when a minimum of 3 consecutive interviews fail to produce novel information in each of the therapeutic categories (haploidentical transplant, non-haploidentical transplant).Transcripts will be analyzed as they are obtained and the principal investigator and study team will iteratively and collaboratively develop a coding dictionary. Each transcript will be reviewed by at least 2 coders. When there is disagreement on a code, coders will meet in person to discuss until consensus is reached. Codes will be grouped into broader themes and used to summarize and describe the bereavement experience as told by parents.
Measured: Once, Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study start1 Mar 2016
- Primary completion21 Aug 2020
- Study completion21 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BereavementStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Baker, MD, Principal investigator, St. Jude Children's Research HospitalErica C. Kaye, MD, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425787
- Sponsor's protocol ID
- BPS14
- Status last verified
- Oct 2021
- First submitted
- 21 Apr 2015
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bereaved Parent Study
- ClinicalTrials.gov ID
- NCT02425787
- Acronym / sponsor ID
- BPS14
- Conditions
- Bereavement
- Keywords
- Loss of a child, Grief
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 24 Apr 2015 (estimated)
- 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.
Recent focus groups at St. Jude Children's Research Hospital (SJCRH) revealed several limitations in our understanding of how parents' relationships with care staff help and hinder their grief experience. Additionally, there is a gap in the bereavement literature regarding the psychological effects professional caregiver relationships have on parents whose children died of cancer. To bolster our knowledge base and benefit Bereavement Care Services at SJCRH, as well as benefit other professionals by filling the gap in the literature, we have designed a qualitative study that will conduct individual interviews with bereaved parents whose children died at SJCRH.
Validation of the preliminary analyses of the initial 30 interviews will occur through new focus groups involving two separate sets of bereaved parents who will validate the findings and/or suggest additional avenues of inquiry needed to gain a more complete understanding of parental grief/bereavement experience. Additionally, focus groups with hematology/oncology fellows will obtain provider feedback on the value of these findings in their training and future role as physicians.
The initial focus group portion of this study is complete and more than 30 interviews have been conducted with bereaved parent participants. Review of those interviews revealed that very few parent participants had children who received bone marrow transplants. For this reason, we will now specifically be recruiting bereaved parent participants whose children received bone marrow transplants at St. Jude Children's Research Hospital. We will be recruiting parents of children who received haploidentical and non-haploidentical bone marrow transplants because we believe the parents of deceased children who received haploidentical bone marrow transplants may have unique bereavement experiences related to their possible roles as donors. The act of donating or not being selected to donate to a child who goes on to die from cancer and its related complications may have unique impacts on the grieving process and warrants specific investigation. We also hope to better understand how legacy building interventions are perceived and utilized by caregivers following the death of a child from cancer.
Detailed description
Participants who consent will engage with the principal investigator in a one-time voice-recorded interview consisting of demographic and open-ended questions. Participants can choose to conduct the interview face-to-face or over-the-phone. Completion of the interview is expected to take between 30-90 minutes. Validation focus groups are expected to take between 30-90 minutes, as well. For the legacy-building cohort, the Child Life Department will provide additional information to specify which bereaved families received legacy items, and parents will be recruited to participate in an interview centered on the legacy item questions.
PRIMARY OBJECTIVE
To conduct qualitative interviews in order to understand what helps and what hinders bereavement processes among St. Jude parents, with particular attention to how relationships with St. Jude professional care staff affect parental bereavement processes.
EXPLORATORY OBJECTIVES
To qualitatively explore the unique bereavement experiences and challenges of parents of children who have received bone marrow transplantation, and compare these experiences with those participants whose children did not receive bone marrow transplantation.
To assess for qualitative similarities among parents with similar responses on questionnaires and/or to identify between-group differences on questionnaires among parents with qualitatively similar experiences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Parents of deceased children (no BMT) | – | Behavioral: InterviewParticipants will be parents who have lost a child at St. Jude Children's Research Hospital (SJCRH). They will participate in a 60-90 minute interview. (Not recruiting) |
| Parents of deceased children (haploidentical BMT) | – | Behavioral: InterviewParticipants will be parents whose child died after receiving a haploidentical bone marrow transplant at St. Jude Children's Research Hospital (SJCRH), and who have not previously participated in an interview through this study. They will participate in a 30-90 minute interview. |
| Parents of deceased children (non-haploidentical BMT) | – | Behavioral: InterviewParticipants will be parents whose child died after receiving a non-haploidentical bone marrow transplant at St. Jude Children's Research Hospital (SJCRH), and who have not previously participated in an interview through this study. They will participate in a 30-90 minute interview. |
| Parents of deceased children (not interviewed) | – | Behavioral: Focus GroupParticipants will be parents who have lost a child at SJCRH, who have not previously participated in an interview through this study.They will participate in a 30-90 minute focus group. |
| Hematology/Oncology Fellows | – | Behavioral: Focus GroupParticipants will be Hematology/Oncology Fellows at SJCRH. They will participate in a 30-90 minute focus group. |
| Legacy-Building | – | Behavioral: InterviewParticipants will be parents who have lost a child at SJCRH and received legacy items. They will participate in a 30-90 minute interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents who have lost a child at SJCRH and who consent to participate in the individual interviews or follow-up focus groups. Hematology/oncology Fellows at SJCRH who consent to participate in the follow up focus groups..
Key inclusion criteria (6 listed)
- Must be at least 18 years of age.
- Must be English-speaking.
- Must have had a child who received oncological treatment at SJCRH.
- The child who received treatment must have died at least 1 year prior but no more than 6 years ago, with the cause of death related to progressive cancer or cancer-related complications.
- OR
Key exclusion criteria (1 listed)
- Potential participants who indicate active suicidal ideation with or without plans will be excluded from the study. Appropriate care and referral will be given as indicated.
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 |
|---|---|---|
| InterviewAlso: QuestionsThis is a prospective study with a semi-structured in-depth qualitative interview. Interviews will be conducted by the study PI or designee. However, in order to ensure that the interviews are conducted sensitively, the first 10 interviews will be observed and supervised by a clinically credentialed St. Jude faculty member, and an additional 10% of the interviews will be observed after that. In order to ensure that the interviewer does not lead the participant, or in turn, that the participant does not feel limited in regards to what they believe is an appropriate or desired response, the semi-structured interview questions are general and intended to produce broad responses in regards to participant experiences. | Behavioural | Parents of deceased children (haploidentical BMT), Parents of deceased children (no BMT), Parents of deceased children (non-haploidentical BMT) |
| Focus GroupAlso: Group question/answer sessionsFocus groups will be conducted with a two-fold purpose in mind: 1. With bereaved parents: to validate the findings of the preliminary analyses of the initial interviews \&/or to suggest avenues of further inquiry to expand and more deeply define the grief journey of bereaved parents. 2. With Hematology/Oncology Fellows: to receive input regarding the applicability and use of the findings during the training and future careers of these medical providers. | Behavioural | Hematology/Oncology Fellows, Parents of deceased children (not interviewed) |
| InterviewAlso: QuestionsThe interview will be conducted by study team members and will center around legacy item-related questions. | Behavioural | Legacy-Building |
Primary outcome
Descriptive accounts of bereavement
Time frame: Once, Day 0
Qualitative data will be collected using a standardized semi-structured interview technique. Researchers will analyze transcripts for content to gain a better understanding of the bereavement experience. Thematic saturation will occur when a minimum of 3 consecutive interviews fail to produce novel information in each of the therapeutic categories (haploidentical transplant, non-haploidentical transplant).Transcripts will be analyzed as they are obtained and the principal investigator and study team will iteratively and collaboratively develop a coding dictionary. Each transcript will be reviewed by at least 2 coders. When there is disagreement on a code, coders will meet in person to discuss until consensus is reached. Codes will be grouped into broader themes and used to summarize and describe the bereavement experience as told by parents.
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 28 Oct 2021.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Justin Baker, MD principal investigator
St. Jude Children's Research Hospital
Erica C. Kaye, MD, MPH principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bereavement, run by St. Jude Children's Research Hospital at 1 site in United States.
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 6 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Descriptive accounts of bereavement (time frame: Once, Day 0). 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 28 Oct 2021.