Trial Outcomes & Findings for The PRISM Intervention for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation (NCT NCT03640325)
NCT ID: NCT03640325
Last Updated: 2024-10-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
143 participants
Primary outcome timeframe
6-months
Results posted on
2024-10-26
Participant Flow
Participant milestones
| Measure |
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
|
Usual Care
Usual psychosocial care (control arm, no intervention)
|
Caregiver
Caregiver of adolescent/young adult participant - surveys only no intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
44
|
49
|
|
Overall Study
COMPLETED
|
37
|
33
|
28
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
21
|
Reasons for withdrawal
| Measure |
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
|
Usual Care
Usual psychosocial care (control arm, no intervention)
|
Caregiver
Caregiver of adolescent/young adult participant - surveys only no intervention.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
21
|
|
Overall Study
Death
|
5
|
5
|
0
|
Baseline Characteristics
Caregivers were not assessed.
Baseline characteristics by cohort
| Measure |
PRISM (Promoting Resilience in Stress Management)
n=50 Participants
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
|
Usual Care
n=44 Participants
Usual psychosocial care (control arm, no intervention)
|
Caregiver
n=49 Participants
Caregiver of the adolescent/young adult participant (no intervention)
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
16.3 years
STANDARD_DEVIATION 4.2 • n=50 Participants
|
17.1 years
STANDARD_DEVIATION 4.2 • n=44 Participants
|
45.5 years
STANDARD_DEVIATION 7.5 • n=49 Participants
|
16.7 years
STANDARD_DEVIATION 4.2 • n=143 Participants
|
|
Sex/Gender, Customized
Female
|
30 Participants
n=50 Participants
|
23 Participants
n=44 Participants
|
33 Participants
n=49 Participants
|
86 Participants
n=143 Participants
|
|
Sex/Gender, Customized
Male
|
20 Participants
n=50 Participants
|
21 Participants
n=44 Participants
|
7 Participants
n=49 Participants
|
48 Participants
n=143 Participants
|
|
Sex/Gender, Customized
Missing
|
0 Participants
n=50 Participants
|
0 Participants
n=44 Participants
|
9 Participants
n=49 Participants
|
9 Participants
n=143 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
33 Participants
n=50 Participants
|
23 Participants
n=44 Participants
|
30 Participants
n=49 Participants
|
86 Participants
n=143 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=50 Participants
|
12 Participants
n=44 Participants
|
0 Participants
n=49 Participants
|
22 Participants
n=143 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
4 Participants
n=50 Participants
|
5 Participants
n=44 Participants
|
2 Participants
n=49 Participants
|
11 Participants
n=143 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=50 Participants
|
4 Participants
n=44 Participants
|
2 Participants
n=49 Participants
|
7 Participants
n=143 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=50 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=49 Participants
|
4 Participants
n=143 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=50 Participants
|
0 Participants
n=44 Participants
|
13 Participants
n=49 Participants
|
13 Participants
n=143 Participants
|
|
Hospital Anxiety and Depression Scale - Total Score
|
10.6 units on a scale
STANDARD_DEVIATION 5.9 • n=50 Participants • Caregivers were not assessed.
|
11.4 units on a scale
STANDARD_DEVIATION 7.2 • n=44 Participants • Caregivers were not assessed.
|
—
|
11.0 units on a scale
STANDARD_DEVIATION 6.5 • n=94 Participants • Caregivers were not assessed.
|
|
Hospital Anxiety and Depression Scale - Depression Subscale
|
4.7 units on a scale
STANDARD_DEVIATION 3.2 • n=50 Participants • Caregiver group not assessed.
|
5.2 units on a scale
STANDARD_DEVIATION 3.8 • n=44 Participants • Caregiver group not assessed.
|
—
|
4.9 units on a scale
STANDARD_DEVIATION 3.5 • n=94 Participants • Caregiver group not assessed.
|
|
Hospital Anxiety and Depression Scale-Anxiety Subscale
|
6.0 units on a scale
STANDARD_DEVIATION 3.3 • n=50 Participants • Caregiver group not assessed.
|
6.2 units on a scale
STANDARD_DEVIATION 3.8 • n=44 Participants • Caregiver group not assessed.
|
—
|
6.1 units on a scale
STANDARD_DEVIATION 3.8 • n=94 Participants • Caregiver group not assessed.
|
|
Snyder Hope Scale
|
47.7 units on a scale
STANDARD_DEVIATION 9.2 • n=50 Participants • Caregiver group not assessed.
|
47.1 units on a scale
STANDARD_DEVIATION 9.4 • n=44 Participants • Caregiver group not assessed.
|
—
|
47.4 units on a scale
STANDARD_DEVIATION 9.3 • n=94 Participants • Caregiver group not assessed.
|
|
Connor-Davidson Resilience Scale
|
27.3 units on a scale
STANDARD_DEVIATION 6.8 • n=50 Participants • Caregiver group not assessed.
|
27.5 units on a scale
STANDARD_DEVIATION 7.3 • n=44 Participants • Caregiver group not assessed.
|
—
|
27.4 units on a scale
STANDARD_DEVIATION 7.0 • n=94 Participants • Caregiver group not assessed.
|
|
Pediatric Quality of Life - Cancer Module
|
69.8 units on a scale
STANDARD_DEVIATION 12.6 • n=50 Participants • Caregiver group not assessed.
|
68.2 units on a scale
STANDARD_DEVIATION 17.3 • n=44 Participants • Caregiver group not assessed.
|
—
|
69.1 units on a scale
STANDARD_DEVIATION 15.9 • n=94 Participants • Caregiver group not assessed.
|
|
Generalized Anxiety Disorder Screener (GAD-7)
|
—
|
—
|
8.1 units on a scale
STANDARD_DEVIATION 5.9 • n=49 Participants • Only caregiver group assessed on this measure.
|
8.1 units on a scale
STANDARD_DEVIATION 5.9 • n=49 Participants • Only caregiver group assessed on this measure.
|
|
Patient Health Questionnaire - 8
|
—
|
—
|
6.3 units on a scale
STANDARD_DEVIATION 5.1 • n=49 Participants • Only caregiver group assessed on this measure.
|
6.3 units on a scale
STANDARD_DEVIATION 5.1 • n=49 Participants • Only caregiver group assessed on this measure.
|
|
Medical Outcomes Study Rand 36-item Health Survey
|
—
|
—
|
71.0 units on a scale
STANDARD_DEVIATION 16.9 • n=49 Participants • Only caregiver group assessed on this measure.
|
71.0 units on a scale
STANDARD_DEVIATION 16.9 • n=49 Participants • Only caregiver group assessed on this measure.
|
PRIMARY outcome
Timeframe: 6-monthsThe 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.
Outcome measures
| Measure |
PRISM (Promoting Resilience in Stress Management)
n=37 Participants
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
|
Usual Care
n=33 Participants
Usual psychosocial care (control arm, no intervention)
|
Caregiver
Caregiver of the adolescent/young adult participant (no intervention)
|
|---|---|---|---|
|
Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score
|
4.55 score on a scale
Standard Deviation 3.35
|
4.03 score on a scale
Standard Deviation 3.83
|
—
|
SECONDARY outcome
Timeframe: 6-monthsThe 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.
Outcome measures
| Measure |
PRISM (Promoting Resilience in Stress Management)
n=37 Participants
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
|
Usual Care
n=33 Participants
Usual psychosocial care (control arm, no intervention)
|
Caregiver
Caregiver of the adolescent/young adult participant (no intervention)
|
|---|---|---|---|
|
PedsQL Generic Core and Cancer-Related Quality of Life Score
|
73.48 score on a scale
Standard Deviation 14.46
|
77.14 score on a scale
Standard Deviation 16.48
|
—
|
SECONDARY outcome
Timeframe: 6-monthsThe 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.
Outcome measures
| Measure |
PRISM (Promoting Resilience in Stress Management)
n=37 Participants
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
|
Usual Care
n=33 Participants
Usual psychosocial care (control arm, no intervention)
|
Caregiver
Caregiver of the adolescent/young adult participant (no intervention)
|
|---|---|---|---|
|
Connor-Davidson Resilience Scale
|
27.65 score on a scale
Standard Deviation 6.95
|
29.64 score on a scale
Standard Deviation 8.94
|
—
|
SECONDARY outcome
Timeframe: 6-monthsThe 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.
Outcome measures
| Measure |
PRISM (Promoting Resilience in Stress Management)
n=37 Participants
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
|
Usual Care
n=33 Participants
Usual psychosocial care (control arm, no intervention)
|
Caregiver
Caregiver of the adolescent/young adult participant (no intervention)
|
|---|---|---|---|
|
Hope Scale Scores
|
47.21 score on a scale
Standard Deviation 11.78
|
49.37 score on a scale
Standard Deviation 10.15
|
—
|
SECONDARY outcome
Timeframe: 6-monthsThe 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.
Outcome measures
| Measure |
PRISM (Promoting Resilience in Stress Management)
n=37 Participants
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
|
Usual Care
n=33 Participants
Usual psychosocial care (control arm, no intervention)
|
Caregiver
Caregiver of the adolescent/young adult participant (no intervention)
|
|---|---|---|---|
|
Hospital Anxiety & Depression Scale Score - Anxiety Sub-score
|
5.86 score on a scale
Standard Deviation 3.39
|
5.13 score on a scale
Standard Deviation 4.19
|
—
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: Only caregivers assessed for this outcome.
7-item survey used to assess anxiety symptoms. Scored from 0-21 with higher scores indicated higher anxiety.
Outcome measures
| Measure |
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
|
Usual Care
Usual psychosocial care (control arm, no intervention)
|
Caregiver
n=28 Participants
Caregiver of the adolescent/young adult participant (no intervention)
|
|---|---|---|---|
|
Generalized Anxiety Disorder Screener (GAD7)
|
—
|
—
|
5.3 units on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: Only caregivers assessed for this outcome.
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.
Outcome measures
| Measure |
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
|
Usual Care
Usual psychosocial care (control arm, no intervention)
|
Caregiver
n=28 Participants
Caregiver of the adolescent/young adult participant (no intervention)
|
|---|---|---|---|
|
Patient Health Questionnaire-8
|
—
|
—
|
4.5 units on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: Only caregivers assessed for this outcome.
This is a measure of health-related quality of life. Scores range from 0-100 and higher scores indicate better health status
Outcome measures
| Measure |
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
|
Usual Care
Usual psychosocial care (control arm, no intervention)
|
Caregiver
n=28 Participants
Caregiver of the adolescent/young adult participant (no intervention)
|
|---|---|---|---|
|
Medical Outcomes Study Rand 36-item Health Survey
|
—
|
—
|
72.0 units on a scale
Standard Deviation 16.2
|
Adverse Events
PRISM (Promoting Resilience in Stress Management)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place