Clinical trial NCT02425787: Bereaved Parent Study
Official title: The Bereaved Parent Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bereavement
Keywords: Loss of a child
Grief
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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..

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.

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.

Eligibility 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 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.

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.

Primary outcomes:
measure: Descriptive accounts of bereavement
timeFrame: Once, Day 0
Secondary outcomes:
Other outcomes:
measure: To qualitatively explore the unique bereavement experiences and challenges of parents of children who received bone marrow transplantation, and compare these experiences with those participants whose children did not receive bone marrow transplantation.
timeFrame: All data will be collected at the time of the initial interview.
measure: 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.
timeFrame: All data will be collected at the time of the initial interview.
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Justin Baker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Jude Children's Research Hospital
name: Erica C. Kaye, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: