Participants will be randomized to either the "Storytelling Through Music" (STM) experimental arm or the waitlist control arm. STM is a six-week intervention that utilizes storytelling, reflective writing, self-care skills (i.e., breathing exercises, meditation, self-compassion, body scans), and songwriting. The intervention is delivered online and in a group setting. Online delivery provides convenience to participants, and the group setting provides an environment of people with shared experiences, which has been shown to decrease social isolation and feelings of being alone in their emotional experience. By the end of the intervention, participants will have written a short story and a song based on their story.

Participants will receive the same "Storytelling Through Music" intervention once data collection from the experimental arm is complete.

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

Storytelling Through Music

Carolyn Phillips

Carolyn Phillips, PhD

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.

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.

Feasibility Study of the Storytelling Through Music Intervention With Bereaved Parents

A Feasibility Study Evaluating Storytelling Through Music Intervention With Bereaved Parents of Children With Cancer

Feasibility will be evaluated by tracking the percentage of participants screened and enrolled. The study will be deemed feasible with a 60% enrollment rate.

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.

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.

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.

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.

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.

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.

UCLA Loneliness Scale; range is 0-60; lower score is better outcome.

Self-Compassion Scale; range is 26-130; higher score is better outcome.

The Metacognition Questionnaire-30; range from 30 - 120; higher score is better outcome.

The Continuing Bonds Scale; ranges from 11-55.

The Prolonged Grief-13-Revised; range 10-50; higher score means greater prolonged grief.

University of Texas at Austin

Assistant Professor

Liza Johnson, MD,MPH

Teen loss is not uncommon. Depression, emptiness, disbelief, hopelessness, and guilt are typical responses. How teens with cancer cope with the loss of a loved one or a close friend has not been well-studied in the bereavement or oncology literature. This study will describe the impact of loss on teen patients who are on treatment or have recently completed treatment for malignancy. We will look at baseline personality traits and ask teens to identify losses in their life. We will ask questions about coping and meaning-making after loss. A parent will be invited to participate -to measure parental awareness of teen loss and determine if parental coping affects teen coping. The inventories have been validated by other researchers.

All participants will asked to complete a bereavement questionnaire quantifying the losses they have experienced. All participants will be screened for depression/anxiety as well as life outlook using validated tools. Patients who identify that they have experienced the loss of someone significant in their life on the bereavement questionnaire will continue with the study and complete a battery of validated psychological inventories. They will be asked to identify their most significant loss in regards to completion of the remainder of the questionnaire. In addition, those who identify losing a friend to cancer will be invited to participate in a 30-45 minute semi-structured interview (in person or via telephone) during a second session with the study staff. This interview will be audiotaped, to allow for transcription and analysis later. Parents will complete demographic information, the bereavement questionnaire, and complete inventories of family coping / cohesion regardless of child's responses to bereavement questionnaire.

In addition, those who identify losing a friend to cancer will be invited to participate in a 30-45 minute semi-structured interview (in person or via telephone) during a second session with the study staff.

Primary Objectives:

* Estimate the prevalence of loss, with particular interest in the extent of peer loss, in adolescent oncology patients who have been on therapy ≥ 12 months (≥ 6 months if progressive or refractory disease) or off therapy for ≤ 3 years.
* Describe the impact of loss on adolescent oncology patients by focusing on coping efficacy, psychological distress, meaning-making, and complicated bereavement.

Secondary Objective:

* Describe parental knowledge of losses experienced by an adolescent child who has recently undergone therapy.

Adolescent Loss: The Impact of Loss on Adolescent Oncology Patients

The prevalence of loss among the participants will be calculated. The type of losses will be described.

All data for this objective will be mainly analyzed in a descriptive manner. The score for coping efficacy will be calculated from the General Coping Efficacy instrument. In addition, a subset of participants who identify losing a friend to cancer will be invited to complete a 30-45 minute semi-structured interview.

Descriptive analysis from the Bereavement Questionnaire (parent version).

St. Jude Children's Research Hospital

Behaviors and Mental Disorders

All Conditions

Caregiver Burden

Stress, Psychological

Behavioral Symptoms

Annina Seiler, PD PhD

The death of a spouse is considered one of the most stressful and impactful life events and is associated with increased morbidity and premature mortality. Early identification of individuals who are most at risk for poor health outcomes following bereavement is an important aim of precision medicine and disease prevention initiatives. A better understanding of caregiver burden and bereavement-related distress and its implication for health is a clinically-relevant step toward the development of treatments that improve health outcomes in bereaved spouses. This study aims to map profiles of individual differences in short- and long-term adjustment to loss, according to psychological (e.g., depression, stress, grief severity) and biological markers (e.g., inflammation, cortisol) over time.

The loss of a spouse is a highly impactful life event that places individuals at risk for mental and physical health problems. Particularly in the immediate weeks and months after the loss, bereavement is associated with a significantly increased risk of multimorbidity and mortality, including elevated inflammation, cardiovascular diseases and some cancers. Grief is a typical reaction to the loss of a significant person and is characterized by symptoms of intense distress, anxiety, yearning, longing, and sadness, all of which generally subside over time. There is considerable variability in how people respond to bereavement. Although the vast majority of bereaved individuals show resilience against loss and adjust adequately without professional psychological support, 10% - 20% of bereaved individuals develop intense and prolonged grief reactions.

The field of psychoneuroimmunology has contributed considerably to our understanding of the effect of stress on the psyche, as well as on the nervous, immune, and endocrine systems. Stressful life events, and the negative emotions they provoke, can induce low-grade inflammation through several autonomic, neuroendocrine, and neuroimmune pathways, which in turn suppress the effectiveness of the immune system, and thereby, increase vulnerability to physical and mental health problems across a person's lifespan. Bereavement is a highly-stressful event, which triggers biological responses via several autonomic, endocrine, and inflammatory mechanisms. Growing evidence suggests that the health consequences of caregiving for terminally-ill patients and bereavement after the loss of a spouse are associated with a wide spectrum of neuroendocrine factors and immunologic and inflammatory markers. Low-grade systemic inflammation, as reflected by elevated concentrations of cytokines (e.g., C-reactive protein, CRP; interleukin 6, IL-6; tumor necrosis factor alpha, TNF-a) is a robust risk factor for the onset of many diseases, including major depression, cardiovascular disease, and stroke.

The caregivers' burden and needs are often not a hospital's priority and overlooked. Yet, the health consequences of caring for a terminally-ill spouse, as well as the need for follow-up care programs for caregivers of a deceased spouse are not well understood. Acknowledging that bereavement-related changes in immune function could account considerably for an increased risk of morbidity and mortality in bereaved individuals, the identification of biobehavioral mechanisms that can be modified or targeted early is an important and clinically-relevant step toward the development of treatments that improve health outcomes in bereaved individuals.

The proposed study is based on the Social Signal Transduction Theory of Depression (Slavich et al.), which suggests that early life stress exposure can shape an individual's neuro-inflammatory sensitivity to stress to later- occurring threats or acute adverse life events, and thereby increase their vulnerability to physical and mental health problems across the lifespan.

The study's aims are two-fold: 1) to map profiles of individual differences in long-term adjustment to loss, according to psychological and biological markers over time; and 2) to examine whether cumulative lifetime stress exposure and neuro-inflammatory sensitivity to stress moderate the association between an acute stressful life event (i.e., the loss of a terminally-ill spouse after a long period of intensive caregiving) and the spouse's health outcomes following bereavement and, thereby, explain individual differences in resilience.

Caregiver Burden and Bereavement-related Distress

The Psychobiological Adjustment to Bereavement Among Cancer Caregivers

heart-rate, heart-rate variability, nail cortisol and cortisone; tumor necrosis factor alpha (TNF-a); c-reactive protein (CRP); testosterone, progesterone, endocannabinoids

University of California, Los Angeles

University of Zurich

Three distinct sub-cohorts will be targeted for recruitment to represent perspectives across the advancing illness course: patients ≤3 months from a poor- prognosis diagnosis (cohort 1), patients ≤ 3 months from disease relapse or progression (cohort 2), and patients actively enrolled on a phase I/II trials (cohort 3).For cohorts 1-3, patient-parent dyads will be enrolled when eligible; however, an independent patient is eligible for enrollment if the parent consents for the patient's enrollment but declines his/her own enrollment.

Four distinct sub-cohorts of parents will be targeted for recruitment, including cohorts 1-3 and a fourth bereavement cohort. For cohorts 1-3, patient-parent dyads will be enrolled when eligible; however, an independent parent is eligible for enrollment if the patient declines enrollment, but the parent wishes to participate.

Pediatric oncologists who treat or refer patients for treatment at St. Jude Children's Research Hospital (SJCRH) will be eligible to participate.

Erica C. Kaye, MD, MPH

This study is being conducted to better understand the preferences and recommendations of patients and parents regarding optimal ways to share prognostic communication. Specifically, to learn what stakeholders (i.e., patients, parents, and doctors) believe to be the "right" content, timing, and delivery of this important information.

Specific Aim 1

* To define key stakeholder preferences and recommendations for timing, content, and delivery of prognostic communication across the advancing illness course and bereavement.

Specific Aim 2

* To engage stakeholders in the design of a patient/parent centered RIGHTime framework and communication intervention to promote individualized, timely prognostic disclosure.

This study will have two phases.

Phase 1:

Investigators will define key stakeholder preferences and recommendations for timing, content, and delivery of prognostic communication across the advancing illness course and bereavement. Eligible parents and patients will participate in semi-structured interviews on prognostic communication preferences, stratified by cohort: poor-prognosis diagnosis, advancing disease, phase I/II trial enrollment, and bereavement; eligible oncologists will complete interviews on prognostic disclosure preferences. Participants will participate in a single interview that will last anywhere from 30 to 60 minutes.The interview will be audio-recorded and transcribed. Participant demographic and social determinants of health information will be collected.

Phase 2:

Investigators will partner with a smaller group of stakeholders (parents, patients, and oncologist) from phase 1 to develop a clinical communication guide to help improve communication between patients, families, and cancer doctors. The panel will meet across 4 sessions to develop a conceptual framework that explains the interconnecting variables influencing stakeholder preferences and to design a prognostic communication intervention (i.e., a RIGHTime communication guide) that encourages oncologists to provide individualized, timely prognostic disclosure.

Revealing Information Genuinely & Honestly Across Time: Pediatric Oncology Stakeholder Preferences and Recommendations for Prognostic Communication

We will use the rapid analysis (RA) qualitative approach for analysis of interview transcripts methods to define patient, parent, and oncologist preferences and recommendations with respect to timing, content, and delivery of prognostic communication at varying timepoints across the advancing illness course.

We will use a participatory design approach with user-centered design methods, we will convene a Stakeholder Panel comprising patients, parents, oncologists, and researchers that will meet across 4 sessions to develop a conceptual framework that explains the interconnecting variables influencing stakeholder preferences and to design a prognostic communication intervention (i.e., a RIGHTime communication guide) that encourages oncologists to provide individualized, timely prognostic disclosure.

Participants will receive the MCGT intervention for approximately 4 months or longer as needed.

Participants will receive the SP intervention for approximately 4 months or longer as needed.

Participants will receive EUC for approximately 4 months or longer as needed.

Meaning-Centered Grief Therapy is a therapy that focuses on helping participants find a sense of meaning or purpose in participants' life after participants' loss. Parents will be provided (via mail or email) a workbook. This support program will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing.

Meaning-Centered Grief Therapy

Supportive Psychotherapy will help participants cope with participants' loss by giving them a place to express participants' feelings and providing participants with support during the sessions. Supportive counseling will involve 16 sessions that will take place about once a week. Each session will last 60 to 90 minutes and will be delivered through videoconferencing.

Supportive Psychotherapy

Enhanced usual care includes any support or resources participants may receive as part of participants' standard care (for example, therapy sessions with a local therapist), enhanced with additional resources.

Enhanced Usual Care

Wendy G. Lichtenthal, PhD

Wendy Lichtenthal

Wendy Lichtenthal, PhD

Talia Zaider, PhD

Lamia Barakat, PhD

Erica Kaye, MD

Erica Kaye

The purpose of this study is to compare three types of support programs for parents who have lost a child. The study will see how these support programs affect participants' grief and depression symptoms. The three support programs are called Meaning-Centered Grief Therapy, Supportive Counseling, and Enhanced Usual Care.

Evaluation of Grief Therapy Approaches for Bereaved Parents

Meaning-Centered Grief Therapy for Parents Bereaved by Cancer: A Multisite Randomized Controlled Trial

The Prolonged Grief-13-Revised (PG-13-R) is a 13-item self-report scale evaluating the proposed symptoms of prolonged grief disorder. The PG-13-R assesses the severity of 10 grief-related symptoms using a 5-point Likert-type scale. Additional items evaluate the experience of a significant loss, symptom duration, and functional impairment. The PG-13-R yields a score between 10 and 50, where a higher score indicates that a person experiences higher levels of prolonged grief.

The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) is a 20-item self-report measure assessing the frequency of depressive symptoms in the past week on a 4-point scale. Total scores range from 0 to 60, with scores above 16 indicating possible clinically significant depression levels.

The PROMIS-Global Health Scale (PROMIS-GH), is a National Institutes of Health-developed and well-validated self-report assessment that captures global mental health (i.e., quality of life, mental health, satisfaction with social activities, and emotional problems) and physical health (i.e., physical health, physical function, pain, and fatigue). PROMIS-GH consists of 10-items, with each utilizing a 7-day recall period. The initial 9-items make use of a 5-point scale, with 3 separate verbal anchors that ask patients to rate their health or abilities, indicate how often they are experiencing a phenomenon or how severe their symptomatic experience is. A final item asks patients to indicate their average pain on a 0-10 numeric rating scale (i.e., 0 = no pain, 10 = worst pain imaginable). The composite score is a sum of each item, and scores range from 10 to 50.

The State-Trait Anxiety Inventory (STAI-SF) is a 10-item valid and reliable self-report measure of both state and trait anxiety. For both of these subscales, higher scores indicate higher levels of anxiety. Responses range from 1 (almost never) to 4 (almost always), with higher scores reflecting increased anxiety.

The Beck Hopelessness Scale-Short Form (BHS-SF) is a 4-item true-false self-report measure of participants' degree of pessimism and hopelessness. Scores range from 0 to 12. A higher score indicates more experiences of pessimism or lack of hope.

The presence of regret and associated distress will be assessed by items used in the investigative team's prior research on regret. The measure asks respondents to rate level of distress associated with regret on a scale from 1-10 with higher scores indicating greater distress.

The Posttraumatic Growth Inventory-Short Form (PTGI-SF) is a 10-item self-report measure that assesses positive outcomes following stressful life events. Scores range from 0 to 50, and higher total scores reflect higher levels of posttraumatic growth.

The Continuing Bonds Scale (CBS) is an 11-item self-report measure that assesses the degree of continued connection with a deceased loved one on a 5-point scale. Scores range from 11 to 55, with higher scores reflecting a stronger continued bond.

The Prolonged Grief Disorder-Clinical Global Impression Scale (PGD-CGI), adapted from trials examining Complicated Grief Treatment, will be used to assess global severity and symptom improvement. It is a two-item observer assessment that uses a seven-point scale for a global rating of illness severity and improvement. Scores range from 1 to 7, with lower scores indicating low severity of symptoms and improvement in functioning.

National Institute of Nursing Research (NINR)

University of Miami

Associate Professor, Pending Rank

Symptoms and General Pathology

Death

Quality of Life

In the intervention arm, Patients and their family caregivers have access to a coping and communication support practitioner (CCSP) (see intervention description) in addition to receiving the usual care in the site.

In the control arm, Patients are receiving the usual care in the site.

Trained clinical nurse specialists with masters� degrees in mental health will serve as CCS practitioners and they will be available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise.

The CCS intervention is tailored to individual preferences over time, and designed to accommodate different age groups, especially older adults and their families.

coping and communication support (CCS) intervention

Julia Rose, PhD MA

The diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making. Family caregivers are greatly affected by the diagnosis and treatment of late-stage cancer in a loved one and may find it difficult to meet the demands of taking care of their loved one through end-of-life care and taking care of their own well-being. This grant provides funding to examine processes and outcomes of the intervention for family caregivers of advanced cancer patients.

We are testing a coping and communication support (CCS) intervention for advanced stage cancer patients and their family caregivers over the period when goals of care may shift, i.e. beginning shortly after diagnosis. This randomized clinical trial is being conducted in two urban tertiary cancer clinics that reach patients and families in low income and diverse underserved populations: the Louis Stokes Cleveland VAMC and MetroHealth Medical Center. Recruitment and randomization are based on patient's diagnosis and age. The patient had to have been diagnosed with a stage IV cancer within a year of enrollment and they must fall into one of two age groups: middle-aged (ages 40-60); or older (61 and older). Patients are stratified by age group and then randomized to usual care or CCS intervention. Family care-givers are randomized along with the patient. Trained clinical nurse specialists with advanced training in mental health serve as CCS practitioners. They are available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.

Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients

National Cancer Institute (NCI)

US Department of Veterans Affairs

Grief responses, levels of vulnerability, measured using the Adult Attitude to Grief scale (AAG), a self-administered questionnaire

The adapted FAM-SOTC-PL intervention was delivered at the home of the participants and focuses on supporting the effective, cognitive, and behavioural domains of the bereaved family caregivers experience by targeting concerns/issues in these categories. The FAM-SOTC-PL comprises of the following five components:

1. Drawing forward narratives about the pre- and post-loss experience.
2. Asking therapeutic/interventive questions, emphasising on the most pressing concerns also assessing health issues.
3. Validating/acknowledging emotional responses.
4. Assessing the need for specific information and recommendations regarding bereavement.
5. The use of commendation/commending strengths, by focusing on and affirming the strengths of the family caregiver.

FAM-SOTC-PL

Background and study aims The effect of cancer caregiving may have profound impact on the psychosocial health of family caregivers and become evident after loss. Grief following the loss of a close relative is one of the most emotional challenging experience faced by family caregivers. Providing a family based intervention before and after a close relatives´death may positively impact bereavement outcomes. This study aims to assess the impact of a continuing specific supportive care intervention on bereaved family caregivers grief response scores and psychological distress following the loss of a close relative when offered before and after death because of cancer.

This clinical trial is part of a broader research study (registered trial intervention ISRCTN21786830) which aimed to evaluate a palliative care nurse-led family-oriented intervention Family-Strengths Oriented Therapeutic Conversation (FAM-SOTC) to support family caregivers of a close relative with advanced/final stage cancer, in the context of the family when receiving specialized palliative home-care. The purpose of the current trial is to investigate the effects of the FAM-SOTC intervention when additionally delivering the third session of the intervention in this trial; an adapted version; FAM-SOTC Post-Loss and repeated post-intervention measures at 3, 5 and six months post-loss completed by bereaved family caregivers who have prior participated in the FAM-SOTC trial intervention pre-loss are compared to measures at 3, 5 and six months post-loss among bereaved family caregivers in a control group who received usual care pre- and post-loss from the palliative home-care unit. The FAM-SOTC intervention and the FAM-SOTC Post Loss intervention is delivered simultaneously in two separate clinical trials, where two sessions were delivered pre-loss (FAM-SOTC) and one session delivered post-loss (FAM-SOTC-PL).

Family Cancer Caregivers Receiving a Specific Supportive Care Intervention Pre- and Postloss

The Effect of Receiving a FAM-SOTC Intervention Before and in the Bereavement Phase (FAM-SOTC-PL) on Bereaved Family Cancer Caregivers Outcomes: A Quasi-experimental Study

The Depression Anxiety Stress Scale - DASS (Lovibond \& Lovibond, 1995) is used. The DASS is a 42-item self-report instrument with 3 sub-scales. Each scale comprises 14 items assessing the negative emotional states of depression, anxiety and stress.

University of Iceland

Usual care participants do not receive an intervention.

The intervention includes 7 LO phone sessions and 7 RO home visits provided by trained interventionists. The primary focus of the LO phone conversations will be on grief work issues, daily functioning, and emotional support. The calls will provide an opportunity to discuss how grief could be interfering with their daily functioning, dealing with grief-related feelings- emotions they are experiencing, the frustrations associated with taking on new responsibilities while still trying to meet their own needs, critical time periods like anniversaries and holidays, unfinished business, coping strategies, including using humor, and having realistic expectations about the bereavement process. The RO home visits will be based specifically on the bereaved partners' skill and knowledge needs.

Individualized DPM

Kathleen H Mooney, PhD

Michael Caserta, PhD

Dale Lund, PhD

Individuals providing end-of-life caregiving to partners with terminal cancer often begin the bereavement process before the patient dies and with additional sources of stress. We know that grief for these partners can be long-term and impact virtually every aspect of their lives. This project will test the effectiveness of a new promising intervention that uses a dual process model (DPM) which focuses both on loss orientation (emotional loss and grief (referred to as LO)) and restoration orientation (learning new tasks of living that may have been the primary responsibility of the spouse who has died (referred to as RO tasks)).

The past emphasis on only the psycho-emotional features of loss has resulted in a lack of attention to the restoration-focused adaptation. Middle-aged and older bereaved persons, including those who previously provided care for a terminally ill spouse or partner, are confronted with unfamiliar daily demands. Even though death due to a terminal illness like cancer may be anticipated, the surviving spouse/partner may be so involved in caring for the dying person and consumed by the emotional distress that accompanies it, there is little time or energy to plan for the changes, some of which are unforeseen prior to the loss. This gap in abilities suggests a need for intervention strategies that improve skills such as mastering tasks of daily living, engaging in self-care behaviors, and functioning socially as a single or uncoupled person in society. One of the major findings in our previous research was the strong association between competencies in tasks of daily living and more favorable adjustments to psycho-emotional aspects of grief.

Some tasks of daily living may have been the primary responsibility of the deceased person. If these skills are not acquired during bereavement, the health, functioning, autonomy and overall quality of life of the bereaved could be adversely affected. Furthermore, the inability to accomplish these tasks interferes with the emotion-focused energy the bereaved need to direct toward the loss itself. Effectively coping with the secondary stress associated with these new challenges reduces the emotional disruption of bereavement. As new skills are gained, the bereaved feel more confident to meet future challenges in their daily lives and some may experience personal growth as they venture into "previously uncharted territory" during a time of transformation independent of their deceased spouses/partners.

While some of the RO challenges are practical, others have health implications (some have both). Self-care behaviors are often partnered activities among couples and the partner's death frequently disrupts these behavioral patterns or interferes with the ability to engage in new ones. The importance for bereaved persons to care for themselves while still addressing the need to grieve represents another set of secondary stressors requiring RO coping strategies. Also, those who more effectively engage in self-care could conceivably be in a better position to address the negative emotional effects of the loss. An important feature of RO is the adaptation to new roles and identities and establishing new relationships and maintaining social connectedness. Older and middle aged bereaved spouses/partners prefer to maintain the meaningful relationships and activities they have had throughout their lives but they also want to learn ways to access services and programs more effectively and how to maximize opportunities to meet and socialize with others. Activities can include inexpensive entertainment and leisure options, safe places to go to socialize with others, and volunteering opportunities to help others so they can remain socially connected and function more effectively and comfortably as a single person. These activities provide potential linkages to the service network and opportunities for time away from grief itself.

The overall intent of the I-DPM intervention is to more effectively stimulate both LO and RO coping processes as well as the oscillation between them than what would otherwise occur without an exposure to such a treatment. At best the usual care hospice caregivers receive after the death of the patient is primarily LO focused as well as infrequent. We hypothesize that those who receive the I-DPM intervention will show greater improvements over time in bereavement outcomes largely because the intervention content will stimulate both LO and RO processes - the telephone support will focus primarily on LO coping while the home visits are intended to address RO issues causing the most concern for the bereaved. In our earlier work we documented that LO coping was directly related to grief, depression, bereavement coping self-efficacy, and loneliness, while RO coping was strongly associated with competencies and personal growth. RO coping, however, also was related to the aforementioned loss-oriented outcomes most likely because of the positive relationship between competencies and the psycho-emotional aspects of bereavement mentioned above and the confidence one can master new challenges along with the perception of growth that accompanies it.

To summarize, bereavement interventions that have traditionally focused on grief work and psycho-emotional outcomes have only been moderately effective, largely due to having a limited focus on emotional coping. Alternatively, an intervention that addresses RO in addition to LO as we are testing in the DPM intervention could provide a more promising solution by helping the bereaved develop skills specific to practical daily challenges as well as the emotional disruption and upset that permeate bereavement.

An Individualized Grief Intervention for Spouses of Cancer Patients After the Patient's Death

Enhancing End-of-Life and Bereavement Outcomes Among Cancer Caregivers: Individualized Dual Process Intervention for Bereaved Partners After Cancer Death

Features of the DPM will be measured using the Inventory of Daily Widowed Life (IDWL) which consists of 22 Likert-format items that inquire into how much time during the past week the respondents spend on loss-orientation (e.g., "Thinking about how much I miss my spouse;" "Feeling a bond with my spouse") and restoration-oriented activities (e. g., "Finding ways to keep busy or occupied;" "Took some time away from grieving for my spouse"). At the end of the 22 IDWL items are several additional questions we developed to measure important dimensions of the oscillation between LO and RO. These features assess oscillation awareness, frequency, and control (each measured on a 5-point Likert scale) and oscillation intent is measured by an open-ended item that asks, "When I go back and forth between dealing with these two issues (grief-related emotions vs. new responsibilities, activities and time away from grieving), I usually do it because __.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility Study of the Storytelling Through Music Intervention With Bereaved Parents	NCT06047808	Pediatric Cance... Grief Well-Being, Psy... Coping Strategi... Bereavement	Storytelling Th...	18 Years - 99 Years	University of Texas at Austin
Adolescent Loss: The Impact of Loss on Adolescent Oncology Patients	NCT01473862	Adolescent Onco...		13 Years - 21 Years	St. Jude Children's Research Hospital
Caregiver Burden and Bereavement-related Distress	NCT05867706	Caregiver Burde... Bereavement Cancer		18 Years -	University of Zurich
Revealing Information Genuinely & Honestly Across Time: Pediatric Oncology Stakeholder Preferences and Recommendations for Prognostic Communication	NCT05116566	Pediatric Cance... Communication		12 Years -	St. Jude Children's Research Hospital
Evaluation of Grief Therapy Approaches for Bereaved Parents	NCT05142605	Grief Bereavement Cancer	Meaning-Centere... Supportive Psyc... Enhanced Usual ...	18 Years -	University of Miami
Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients	NCT00106067	Aging Neoplasms	coping and comm...	18 Years -	VA Office of Research and Development
Family Cancer Caregivers Receiving a Specific Supportive Care Intervention Pre- and Postloss	NCT03850132	Bereavement	FAM-SOTC-PL	18 Years -	University of Iceland
An Individualized Grief Intervention for Spouses of Cancer Patients After the Patient's Death	NCT02112084	Bereavement Death Cancer	Individualized ...	45 Years -	University of Utah
Adolescent Loss: The Impact of Loss on Adolescent Oncology Patients	NCT01473862	Adolescent Onco...		13 Years - 21 Years	St. Jude Children's Research Hospital
Caregiver Burden and Bereavement-related Distress	NCT05867706	Caregiver Burde... Bereavement Cancer		18 Years -	University of Zurich

Spots Global Cancer Trial Database for bereavement

Every month we try and update this database with for bereavement cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bereavement

Every month we try and update this database with for bereavement cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bereavement cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.