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Bereaved Parent Study

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ClinicalTrials.gov Identifier: NCT02425787
Recruitment Status : Recruiting
First Posted : April 24, 2015
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief 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. 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.


Condition or disease Intervention/treatment
Bereavement Behavioral: Interview Behavioral: Focus Group

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 60-90 minutes. Validation focus groups are expected to take between 60-90 minutes, as well.

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. Focus groups will provide additional groups of bereaved parents with an opportunity to validate initial findings and/or suggest additional avenues of inquiry to expand our understanding of the grief/bereavement experience, and gain provider insight into how these findings should be used to improve the training of hematology/oncology Fellows.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Bereaved Parent Study
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

Group/Cohort Intervention/treatment
Parents
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.
Behavioral: Interview

This is a prospective study with a semi-structured in-depth qualitative interview. Interviews will be solely conducted by the study PI. 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 PI 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.

Other Name: Question

Bereaved parents of BMT patients
Participants will be parents whose child died after receiving a 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 60-90 minute interview.
Behavioral: Interview

This is a prospective study with a semi-structured in-depth qualitative interview. Interviews will be solely conducted by the study PI. 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 PI 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.

Other Name: Question

Bereaved parents
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 60-90 minute focus group.
Behavioral: Focus Group

Focus 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.
Other Name: Group question/answer sessions

Hematology/oncology fellows
Participants will be Hematology/oncology Fellows at SJCRH. They will participate in a 60-90 minute focus group.
Behavioral: Focus Group

Focus 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.
Other Name: Group question/answer sessions




Primary Outcome Measures :
  1. Number of themes by type of help or hindrance to grief processes [ Time Frame: Once, Day 0 ]

    Qualitative data will be collected using standard questionnaires. Thematic saturation will occur when a minimum of 3 consecutive interviews fail to produce novel information in each of 3 diagnostic categories (Solid Tumor, Hematologic, Brain).

    After all diagnostic subcategories have reached thematic saturation, and the PI and his collaborating team member have finalized their code definitions, two additional individuals will serve as independent raters and analyze the interviews. Inter-coder reliability will be calculated using Kappa coefficients. The frequency of each code will be tallied and the number of themes by type of help or hindrance will be reported.

    Follow-up focus groups will serve to validate the preliminary findings of the initial 30 interviews, and provide input on the applicability of these findings to the future training of hematology/oncology Fellows.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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..
Criteria

Inclusion Criteria:

  • 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 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425787


Contacts
Contact: Lindsay Blazin, MD 866-278-5833 referralinfo@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Lindsay Blazin, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Lindsay Blazin, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Lindsay Blazin, MD St. Jude Children's Research Hospital

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02425787     History of Changes
Other Study ID Numbers: BPS14
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Loss of a child
Grief