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.
