Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06047808
Other study ID # STUDY00004111
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date August 2025

Study information

Verified date April 2024
Source University of Texas at Austin
Contact Carolyn Phillips
Phone 512-475-7039
Email carolyn.phillips@nursing.utexas.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The death of a child, at any age, is considered one of the most stressful life events a person can experience. In 2020, 11,050 children (under 15 years), 5,000 adolescents (15-19 years) and 60,000 young adults (20-39 years) were estimated to be diagnosed with cancer in the US. While the five-year survival is better for children than adults, over 10,000 children, adolescents, and young adults die from cancer in the US each year.1 Bereaved parents often experience intense and lasting psychological distress resulting in significantly higher morbidity and mortality compared to non-bereaved parents. Twenty-five percent of bereaved parents report new diagnoses of illnesses including prediabetes, anxiety and sleep disorders. Bereaved parents also experience psychological distress such as anxiety, post-traumatic stress disorder, and grief-related depressive symptoms that continue to be significant for years after a child's death. A recent study showed that nearly 33% of bereaved parents suffered from prolonged grief five years after their loss.6 Physiologically, studies show increased cortisol, immune, endocrine, and cardio biomarkers in people with prolonged grief. The death of a child can also affect family and social relationships resulting in decreased communication, feelings of isolation, absence of close social relationships and increased marital strain and divorce. The purpose of this randomized controlled pilot study is to evaluate the feasibility of implementing a six-week multi-dimensional intervention, Storytelling Through Music (STM), with parents of children who have died from cancer. STM combines multiple modalities of expression (storytelling, writing, and music) to facilitate loss- and restoration-oriented coping by creating a legacy piece (self-written story paired with song) to facilitate continuing bonds with the deceased and find meaning.


Description:

The death of a child, at any age, is considered one of the most stressful life events a person can experience. In 2020, 11,050 children (under 15 years), 5,000 adolescents (15-19 years), and 60,000 young adults (20-39 years) were estimated to be diagnosed with cancer in the US. While the five-year survival is better for children than adults, over 10,000 children, adolescents, and young adults die from cancer in the US each year. Bereaved parents often experience intense and lasting psychological distress resulting in significantly higher morbidity and mortality than non-bereaved parents. Twenty-five percent of bereaved parents report new diagnoses of illnesses, including prediabetes, anxiety, and sleep disorders. Bereaved parents also experience psychological distress, such as anxiety, post-traumatic stress disorder, and grief-related depressive symptoms that continue to be significant for years after a child's death. A recent study showed that nearly 33% of bereaved parents suffered from prolonged grief five years after their loss. Physiologically, studies show increased cortisol, immune, endocrine, and cardio biomarkers in people with prolonged grief. The death of a child can also affect family and social relationships resulting in decreased communication, feelings of isolation, absence of close social relationships, and increased marital strain and divorce. The World Health Organization and the National Coalition for Hospice and Palliative Care (NCHPC) advocate that palliative care should not only improve the quality of life of patients but also extend into bereavement for families. The NCHPC bereavement guideline (7.5.1.c) states that bereavement interventions should include rituals that acknowledge loss and transition, provide opportunities for remembrance, and establish a sense of community. Researchers have examined the use of life review, dignity therapy, and remembrance with pediatric and adolescent patients, as well as bereaved family caregivers of spouses. However, to our knowledge, none have been conducted with bereaved parents. Despite the high risk of negative outcomes and national guidelines recommending bereavement care, the resources for bereaved parents are scarce. In a recent systematic review of intervention studies for bereaved parents, only fifteen interventions were identified. Of those studies, most lacked empirical evidence of effectiveness or alignment with key theoretical concepts. To increase the number of effective resources for this vulnerable and underserved population, interventions need to be developed and tested in order to promote health and disease prevention in this high-risk population. Mechanisms of Coping with Parental Grief Parental bereavement is complex because many personal, relational, and end-of-life circumstances affect bereavement, and individuals cope differently. Several factors are associated with prolonged grief and poorer psychosocial outcomes, including intra-personal (i.e., attachment style, sex, religious beliefs, age, history of mental health problems), inter-personal (i.e., social support, family, culture, religious practice, resources), and the unexpectedness of the loss. However, none of these factors are easily changed by interventions. Focusing on modifiable processes that mediate or moderate the adaptation trajectory in bereavement may be more beneficial. In bereaved adults, processes that mediate the relationship between risk factors and mental health outcomes include rumination, deliberate grief avoidance, emotional expression, cognitive appraisals, and meaning-making. Meta-Affective and Meta-Cognitive Effects of Grief A growing body of research suggests that self-compassion is positively associated with well-being and negatively associated with depression, anxiety, and post-traumatic stress. Self-compassion recognizes suffering as a universally shared human experience and teaches people to face their suffering non-judgmentally with a kind and mindful approach. Only one study has examined the influence of self-compassion on grief processing, showing a significant relationship between low self-compassion and the severity of complicated grief. Self-compassion may be beneficial in coping with grief because it is associated with engagement in, rather than avoidance of, painful thoughts, memories, and feelings. Furthermore, research on meta-cognition has shown that maladaptive coping strategies such as rumination are driven by metacognitive appraisals of an internal or external event. Meta-cognitive beliefs may keep bereaved people focused on loss issues, preventing them from integrating the loss into their lives and planning for the future. Affective and Cognitive Effects of Expressive Arts Expressive arts have been used to improve psychosocial well-being in people with cancer, adolescents with grief, veterans with post-traumatic stress disorder, and to aid bereavement among family caregivers. Yet, many of these studies lack methodological rigor. Interventions aimed at meaning-making are good for individuals at high risk for prolonged grief. Music has been used across cultures, and there is growing evidence that music is often more powerful than language alone in eliciting emotion, is processed throughout spinal, subcortical, and cortical regions, and thus has meaningful impacts on complex cognitive and affective processes. While music and language utilize similar features in the brain, music is more rooted in the primitive brain structures involved in motivation, reward, and emotion. Within the brain, emotional, language, and memory centers are connected during music processing. Theoretical/Conceptual Framework Two complementary models guide this study: The Dual-Process Model of Coping with Bereavement and the Meaning Reconstruction Model. Both models view grief as a life-long process of renegotiating continuing bonds with the deceased and finding meaning in life after the loss. The dual-process model posits that grieving a loved one entails oscillating between orientation to the loss (i.e., continuing bonds with the deceased by expressing emotion related to the death and reconnecting with the memory of the loved one) and restoration of contact with a changed world (i.e., re-engaging relationships and experimenting with new life roles). The meaning reconstruction model of grief views grieving as a process of reaffirming or reforming a world of meaning that has been challenged by loss. Research on these models demonstrates signs of efficacy, particularly regarding how continuing bonds with the deceased and meaning-making are important mechanisms of successful adaption to bereavement. Preliminary Work This team has implemented two pilot studies examining the in-person and online delivery of STM to professional caregivers. In both studies, the intervention delivery method was feasible and significant improvements were seen in coping (self-compassion (F(3, 105) = 2.88, p<.05), self-awareness (F(3, 120) = 2.42, p<.10), psychosocial (loneliness (F(3, 98) = 7.46, p<.001), and functional (insomnia (F(3, 120) = 5.77, p<.001) well-being. Qualitatively, participants reported feeling less emotional loneliness, and the stories and songs provided reflection and meaning-making. An unexpected finding from this study was that 60% of participants in the intervention arm had experienced a significant family loss (mostly to cancer) that inspired their oncology nursing careers. During the intervention, this primary family loss, with the grief they needed to examine. This finding informed our team of the need for bereavement interventions for family caregivers.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - >18 years old - able to read and speak English - bereaved parent of a child who died from cancer (ages<39 years) - child's death >6 months and <5 years before study initiation - access to the internet and computer. Exclusion Criteria: - do not have the technological requirements for Zoom interviews and REDCap surveys.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Storytelling Through Music
"Storytelling Through Music" is a six-week expressive arts intervention.

Locations

Country Name City State
United States University of Texas at Austin Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Study Feasibility Feasibility will be evaluated by tracking the percentage of participants screened and enrolled. The study will be deemed feasible with a 60% enrollment rate. Immediately post-intervention (6 weeks)
Primary Intervention Feasibility Feasibility will be evaluated by tracking the average number of sessions the participants complete. This intervention will be deemed feasible if 85% of the intervention is completed. Immediately post-intervention (6 weeks)
Primary Intervention Acceptability An additional primary endpoint is acceptability. Acceptability will be evaluated with semi-structured interview questions to understand the participant's perception of intervention delivery and content, as well as the perceived impact. Immediately post-intervention (6 weeks)
Secondary Mean Change from Baseline in Anxiety Scores at 6 weeks and 10 weeks The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short-Form 8a will be used. The minimum score is 8, and the maximum score is 40. Higher scores indicate more anxiety. Immediately post-intervention and 1-month post-intervention
Secondary Mean Change from Baseline in Depression Scores at 6 weeks and 10 weeks The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form 8a will be used.The minimum score is 8, and the maximum score is 40. Higher scores indicate higher levels of depressive symptoms. Immediately post-intervention and 1-month post-intervention
Secondary Mean Change from Baseline in Quality of Life Scores at 6 weeks and 10 weeks The Patient-Reported Outcomes Measurement Information System (PROMIS) Quality of Life scale (10 items) will be used. The minimum score is 5, and the maximum score is 50. Higher scores indicate more sleep disturbance. Immediately post-intervention and 1-month post-intervention
Secondary Mean Change from Baseline in Sleep Disturbance Scores at 6 weeks and 10 weeks The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short-Form 6a will be used. The minimum score is 6, and the maximum score is 30. Higher scores indicate more sleep disturbance. Immediately post-intervention and 1-month post-intervention
Secondary Mean Change from Baseline in Loneliness Scores at 6 weeks and 10 weeks UCLA Loneliness Scale; range is 0-60; lower score is better outcome. Immediately post-intervention and 1-month post-intervention
Secondary Mean Change from Baseline in Self-Compassion Scores at 6 weeks and 10 weeks Self-Compassion Scale; range is 26-130; higher score is better outcome. Immediately post-intervention and 1-month post-intervention
Secondary Mean Change from Baseline in Metacognition Scores at 6 weeks and 10 weeks The Metacognition Questionnaire-30; range from 30 - 120; higher score is better outcome. Immediately post-intervention and 1-month post-intervention
Secondary Mean Change from Baseline in Continuing Bonds Scores at 6 weeks and 10 weeks The Continuing Bonds Scale; ranges from 11-55. Immediately post-intervention and 1-month post-intervention
Secondary Mean Change from Baseline in Prolonged Grief Scores at 6 weeks and 10 weeks The Prolonged Grief-13-Revised; range 10-50; higher score means greater prolonged grief. Immediately post-intervention and 1-month post-intervention
See also
  Status Clinical Trial Phase
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Not yet recruiting NCT06335745 - PediCARE Health Equity Intervention in High-Risk Neuroblastoma N/A
Withdrawn NCT04719416 - Relaxation Therapy in Pediatric Oncology N/A
Completed NCT01645436 - Physical Activity in Pediatric Cancer (PAPEC) N/A
Completed NCT04409301 - Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation N/A
Completed NCT04914702 - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Recruiting NCT05425043 - Granulocyte Transfusions After Umbilical Cord Blood Transplant N/A
Recruiting NCT05071859 - Genetic Overlap Between Anomalies and Cancer in Kids in the Children's Oncology Group: The COG GOBACK Study
Recruiting NCT03241251 - Screening for Psychosocial Risk in Flemish Families of a Child With Cancer
Recruiting NCT05384288 - Response to Influenza Vaccination in Pediatric Oncology Patients
Completed NCT04586491 - The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients N/A
Recruiting NCT05569512 - Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML Phase 1/Phase 2
Enrolling by invitation NCT05294380 - Determination of Sarcopenia Risk and Related Factors in Pediatric Oncological Patients
Completed NCT02675166 - Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
Completed NCT02665819 - Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility. N/A
Not yet recruiting NCT05454163 - Post-radiotherapy Rhinosinusitis in Children
Terminated NCT02536183 - A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors Phase 1
Withdrawn NCT01828502 - Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer Phase 2
Completed NCT02032121 - Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors N/A
Completed NCT03964259 - Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia Phase 1