Bereavement Clinical Trial
Official title:
The Bereaved Parent Study
NCT number | NCT02425787 |
Other study ID # | BPS14 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2016 |
Est. completion date | August 21, 2020 |
Verified date | October 2021 |
Source | St. Jude Children's Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | August 21, 2020 |
Est. primary completion date | August 21, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | We will use qualitative content analysis as described above to identify similarities and differences among the different cohorts of bereaved parents (parents whose children did not receive bone marrow transplantation, parents whose children received haploidentical bone marrow transplantation, and parents whose children received non-haploidentical bone marrow transplantation. | All data will be collected at the time of the initial interview. | |
Other | 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. | We will use the Beck Depression Inventory-II (BDI-II) to assess for symptoms of depression, the parental grief disorder questionnaire (PG-13) to assess for atypical or disordered grief, and the Integration of Stressful Life Experiences Scales (ISLES-SF) to measure the extent to which the child's loss has been integrated into the parent's worldview. We will identify different groups based on these questionnaires (ex: those with elevated scores on the BDI-II) and look to see if the thematic content of their interviews differs from other participants. Additionally, we may identify participants who expressed certain themes and assess for differences in their qualitative responses. | All data will be collected at the time of the initial interview. | |
Primary | 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. | Once, Day 0 |
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