Adherence, Medication, Adolescent Behavior, Anxiety, Bone Marrow Neoplasms, Cancer, Coping Skills, Depression, Quality of Life
Conditions
Brief summary
Multisite Randomized Controlled Trial (RCT) testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults receiving hematopoietic cell transplantation for hematology malignancy.
Detailed description
The experience of hematopoietic cell transplantation (HCT) for malignancy or cancer predisposition among Adolescents and Young Adults (AYAs) is particularly difficult because age-related developmental challenges of identity, relationships, and vocation may add to the burden of cancer. Compared to other age-groups, AYAs have poorer psychosocial outcomes including increased anxiety and depression and poorer adherence to oral immunosuppressive medications. These outcomes may, in turn, predispose AYAs to disease-related morbidity and mortality such as graft-versus-host disease (GVHD) and/or cancer-relapse. A potential barrier to improving these experiences may be that AYAs have few opportunities to develop the personal resources needed to handle adversity. We have previously developed the Promoting Resilience in Stress Management (PRISM) intervention for AYAs with serious illness. This manualized, brief intervention is delivered in 4, 30-60 minute, one-on-one sessions, followed by a Parent/ Caregiver/ Spouse/ significant other inclusive meeting. It targets skills in stress-management and mindfulness, goal-setting, positive reframing, and meaning-making. All of these skills are associated with improved patient well-being in other populations, and preliminary findings from a recently closed phase II randomized controlled trial among AYAs with newly diagnosed cancer suggest PRISM is associated with improved health-related quality of life. This study will build on our prior experience and fill a critical knowledge gap regarding PRISM's impact among AYAs receiving HCT. Thus, we will conduct a multi-site randomized controlled trial with the primary trial outcome of patient-reported symptoms of anxiety and depression. Secondary and exploratory outcomes will include the cost-effectiveness of the intervention in this population, the impact of the intervention on parent well-being, and patient adherence to oral graft-versus-host-disease medications. We hypothesize that AYAs who receive PRISM will report fewer mixed affective symptoms, while their parents report improved quality of life and psychological distress. We also anticipate the intervention will positively impact adherence and be cost-effective. In sum, this study offers an opportunity to expand the body of knowledge regarding methodologically rigorous and evidence-based psychosocial interventions and standards of care for AYAs with hematologic malignancies. Ultimately, this research has the potential to reduce the burden of cancer in these vulnerable populations.
Interventions
BEHAVIORALPRISM (Promoting Resilience in Stress Management)
Manualized Skills-Training Program targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making
Sponsors
Children's Hospital Los Angeles
St. Jude Children's Research Hospital
University of Alabama at Birmingham
National Cancer Institute (NCI)
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
for adolescent/young adult (AYA) patient: * Patient aged 12-24 years * Receiving hematopoietic cell transplantation (HCT) for malignancy or cancer predisposition syndrome * Within 4 weeks of HCT day zero * Able to speak English * Able to read English or Spanish * Cognitively able to participate in interviews
Exclusion criteria
for AYA patient: * Patient refusal * Cognitively or physically unable to participate in interviews * Unable to speak English * Unable to read English or Spanish For enrolled caregivers of AYA patient (no age limit): Inclusion criteria: * AYA Child of caregiver agreed to participate * One caregiver per patient-caregiver dyad * Parent/guardian cognitively and physically able to participate * Parent/guardian is able to speak/read English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score | 6-months | The Hospital Anxiety and Depression Scale -Depression sub scale assesses mixed affective symptoms in patients with serious illness. The scale consists of 7 questions for depression. Each is scored from 0-3, for a total range of 0-21 points. Caseness of depression is defined as ≥8 points, with sensitivity/specificity of 0.8/0.8 for depression. The depression sub-scale will be measured as a continuous variable. Higher scores indicate more symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Connor-Davidson Resilience Scale | 6-months | The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. The 10-item instrument has high internal consistency. Each item consists of a 5-point Likert scale (scored from zero to four). ranging from 0-40 with higher scores reflecting greater perceived resilience. |
| Hope Scale Scores | 6-months | The Snyder Hope Scale measures the overall perception that one's goals can be met. The instrument scored on an 8-point Likert scale (score range 0-64). Higher scores imply greater levels of hopeful thought patterns. |
| Hospital Anxiety & Depression Scale Score - Anxiety Sub-score | 6-months | The Hospital Anxiety and Depression Scale - Anxiety sub scale assesses mixed affective symptoms in patients with serious illness. It consists of 7 questions on a 3 point Likert scale for a total range of 0-21. Higher scores indicate higher anxiety. |
| PedsQL Generic Core and Cancer-Related Quality of Life Score | 6-months | The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life of adolescents and young adults (AYAs) with cancer. Items are rated on a 5-point Likert scale and total scores transformed to a 0-100 scale with higher scores representing better HRQOL. Internal consistency ranges from 0.75 to 0.92. |
| Patient Health Questionnaire-8 | 6-months | 8-item survey assessing depression severity. Each item scored on a 4-point Likert scale with a range of 0-27. Higher scores indicate higher depression. |
| Medical Outcomes Study Rand 36-item Health Survey | 6-months | This is a measure of health-related quality of life. Scores range from 0-100 and higher scores indicate better health status |
| Generalized Anxiety Disorder Screener (GAD7) | 6-months | 7-item survey used to assess anxiety symptoms. Scored from 0-21 with higher scores indicated higher anxiety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PRISM (Promoting Resilience in Stress Management) Resilience Skills Training
PRISM (Promoting Resilience in Stress Management): Manualized Skills-Training Program targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making | 50 |
| Usual Care Usual psychosocial care (control arm, no intervention) | 44 |
| Caregiver Caregiver of the adolescent/young adult participant (no intervention) | 49 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 5 | 5 | 0 |
| Overall Study | Lost to Follow-up | 4 | 5 | 21 |
| Overall Study | Withdrawal by Subject | 4 | 1 | 0 |
Baseline characteristics
| Characteristic | PRISM (Promoting Resilience in Stress Management) | Total | Caregiver | Usual Care |
|---|---|---|---|---|
| Age, Continuous | 16.3 years STANDARD_DEVIATION 4.2 | 16.7 years STANDARD_DEVIATION 4.2 | 45.5 years STANDARD_DEVIATION 7.5 | 17.1 years STANDARD_DEVIATION 4.2 |
| Connor-Davidson Resilience Scale | 27.3 units on a scale STANDARD_DEVIATION 6.8 | 27.4 units on a scale STANDARD_DEVIATION 7 | — | 27.5 units on a scale STANDARD_DEVIATION 7.3 |
| Generalized Anxiety Disorder Screener (GAD-7) | — | 8.1 units on a scale STANDARD_DEVIATION 5.9 | 8.1 units on a scale STANDARD_DEVIATION 5.9 | — |
| Hospital Anxiety and Depression Scale-Anxiety Subscale | 6.0 units on a scale STANDARD_DEVIATION 3.3 | 6.1 units on a scale STANDARD_DEVIATION 3.8 | — | 6.2 units on a scale STANDARD_DEVIATION 3.8 |
| Hospital Anxiety and Depression Scale - Depression Subscale | 4.7 units on a scale STANDARD_DEVIATION 3.2 | 4.9 units on a scale STANDARD_DEVIATION 3.5 | — | 5.2 units on a scale STANDARD_DEVIATION 3.8 |
| Hospital Anxiety and Depression Scale - Total Score | 10.6 units on a scale STANDARD_DEVIATION 5.9 | 11.0 units on a scale STANDARD_DEVIATION 6.5 | — | 11.4 units on a scale STANDARD_DEVIATION 7.2 |
| Medical Outcomes Study Rand 36-item Health Survey | — | 71.0 units on a scale STANDARD_DEVIATION 16.9 | 71.0 units on a scale STANDARD_DEVIATION 16.9 | — |
| Patient Health Questionnaire - 8 | — | 6.3 units on a scale STANDARD_DEVIATION 5.1 | 6.3 units on a scale STANDARD_DEVIATION 5.1 | — |
| Pediatric Quality of Life - Cancer Module | 69.8 units on a scale STANDARD_DEVIATION 12.6 | 69.1 units on a scale STANDARD_DEVIATION 15.9 | — | 68.2 units on a scale STANDARD_DEVIATION 17.3 |
| Race/Ethnicity, Customized Asian | 1 Participants | 7 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants | 22 Participants | 0 Participants | 12 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 13 Participants | 13 Participants | 0 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 4 Participants | 11 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 33 Participants | 86 Participants | 30 Participants | 23 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 4 Participants | 2 Participants | 0 Participants |
| Sex/Gender, Customized Female | 30 Participants | 86 Participants | 33 Participants | 23 Participants |
| Sex/Gender, Customized Male | 20 Participants | 48 Participants | 7 Participants | 21 Participants |
| Sex/Gender, Customized Missing | 0 Participants | 9 Participants | 9 Participants | 0 Participants |
| Snyder Hope Scale | 47.7 units on a scale STANDARD_DEVIATION 9.2 | 47.4 units on a scale STANDARD_DEVIATION 9.3 | — | 47.1 units on a scale STANDARD_DEVIATION 9.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 50 | 5 / 44 |
| other Total, other adverse events | 0 / 50 | 0 / 44 |
| serious Total, serious adverse events | 0 / 50 | 0 / 44 |
Outcome results
Primary
Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score
The Hospital Anxiety and Depression Scale -Depression sub scale assesses mixed affective symptoms in patients with serious illness. The scale consists of 7 questions for depression. Each is scored from 0-3, for a total range of 0-21 points. Caseness of depression is defined as ≥8 points, with sensitivity/specificity of 0.8/0.8 for depression. The depression sub-scale will be measured as a continuous variable. Higher scores indicate more symptoms.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM (Promoting Resilience in Stress Management) | Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score | 4.55 score on a scale | Standard Deviation 3.35 |
| Usual Care | Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score | 4.03 score on a scale | Standard Deviation 3.83 |
Secondary
Connor-Davidson Resilience Scale
The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. The 10-item instrument has high internal consistency. Each item consists of a 5-point Likert scale (scored from zero to four). ranging from 0-40 with higher scores reflecting greater perceived resilience.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM (Promoting Resilience in Stress Management) | Connor-Davidson Resilience Scale | 27.65 score on a scale | Standard Deviation 6.95 |
| Usual Care | Connor-Davidson Resilience Scale | 29.64 score on a scale | Standard Deviation 8.94 |
Secondary
Generalized Anxiety Disorder Screener (GAD7)
7-item survey used to assess anxiety symptoms. Scored from 0-21 with higher scores indicated higher anxiety.
Time frame: 6-months
Population: Only caregivers assessed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver | Generalized Anxiety Disorder Screener (GAD7) | 5.3 units on a scale | Standard Deviation 4.9 |
Secondary
Hope Scale Scores
The Snyder Hope Scale measures the overall perception that one's goals can be met. The instrument scored on an 8-point Likert scale (score range 0-64). Higher scores imply greater levels of hopeful thought patterns.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM (Promoting Resilience in Stress Management) | Hope Scale Scores | 47.21 score on a scale | Standard Deviation 11.78 |
| Usual Care | Hope Scale Scores | 49.37 score on a scale | Standard Deviation 10.15 |
Secondary
Hospital Anxiety & Depression Scale Score - Anxiety Sub-score
The Hospital Anxiety and Depression Scale - Anxiety sub scale assesses mixed affective symptoms in patients with serious illness. It consists of 7 questions on a 3 point Likert scale for a total range of 0-21. Higher scores indicate higher anxiety.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM (Promoting Resilience in Stress Management) | Hospital Anxiety & Depression Scale Score - Anxiety Sub-score | 5.86 score on a scale | Standard Deviation 3.39 |
| Usual Care | Hospital Anxiety & Depression Scale Score - Anxiety Sub-score | 5.13 score on a scale | Standard Deviation 4.19 |
Secondary
Medical Outcomes Study Rand 36-item Health Survey
This is a measure of health-related quality of life. Scores range from 0-100 and higher scores indicate better health status
Time frame: 6-months
Population: Only caregivers assessed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver | Medical Outcomes Study Rand 36-item Health Survey | 72.0 units on a scale | Standard Deviation 16.2 |
Secondary
Patient Health Questionnaire-8
8-item survey assessing depression severity. Each item scored on a 4-point Likert scale with a range of 0-27. Higher scores indicate higher depression.
Time frame: 6-months
Population: Only caregivers assessed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver | Patient Health Questionnaire-8 | 4.5 units on a scale | Standard Deviation 4.7 |
Secondary
PedsQL Generic Core and Cancer-Related Quality of Life Score
The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life of adolescents and young adults (AYAs) with cancer. Items are rated on a 5-point Likert scale and total scores transformed to a 0-100 scale with higher scores representing better HRQOL. Internal consistency ranges from 0.75 to 0.92.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRISM (Promoting Resilience in Stress Management) | PedsQL Generic Core and Cancer-Related Quality of Life Score | 73.48 score on a scale | Standard Deviation 14.46 |
| Usual Care | PedsQL Generic Core and Cancer-Related Quality of Life Score | 77.14 score on a scale | Standard Deviation 16.48 |