Anxiety, Cancer, Communication, Coping Skills, Depression, Hope, Quality of Life
Conditions
Brief summary
Multi-Site Randomized Controlled Trial testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults with Advanced Cancer
Detailed description
Among patients with cancer and their families, early integration of palliative care may improve quality of life. This is particularly important for Adolescents and Young Adults (AYAs) because their distinct developmental challenges related to identity, relationships, and vocation may add to the burden of cancer. Among AYAs with advanced cancer, most understand that they may die and report that discussing end-of-life preferences, goals, and fears would be helpful; however, only 53% engage in such conversations. While national guidelines call for integrated palliative care in AYA oncology, developmentally targeted, evidence-based interventions designed to meet psychosocial and communication needs are lacking. A potential barrier to improving the experiences of AYAs with advanced cancer may be their limited opportunities to develop resilience resources such as stress-management, goal-setting, positive reframing, and meaning-making skills. These resources may mitigate negative outcomes, facilitate engagement in goals of care discussions, and improve quality of life. Furthermore, promoting these resources among AYAs may give them the tools to more successfully navigate the challenges of the cancer experience. Our research program is built on the central hypothesis that promoting resilience resources will improve psychosocial well-being. Over a series of studies, we developed a conceptual framework of resilience in pediatric cancer, affirmed associations between resilience resources and outcomes, and developed a novel resilience resources intervention (Promoting Resilience in Stress Management, PRISM). PRISM is a manualized, skills-based training program comprised of four 30-60 minute, in-person, one-on-one sessions plus a facilitated parent/caregiver/spouse/significant other family-meeting. We completed a pilot Randomized Controlled Trial (RCT) to test the efficacy of PRISM among 100 AYAs, 6-months following their diagnosis of new (n=73) or recurrent (n=27) cancer. Results suggest PRISM is feasible, highly acceptable, and associated with increased patient-reported resilience as well as key clinically significant patient-centered outcomes such as quality of life and psychological distress. Subgroup analyses comparing patients with advanced cancer to those with new cancer suggested differentially stronger positive effects in the advanced cancer group, raising a hypothesis to be tested in dedicated trials. However, qualitative feedback from patients with advanced cancer suggested refinements targeting hopes, worries, and contextual meaning-making might strengthen PRISM's usefulness. The overall objective of this project is to refine PRISM to meet the distinct needs of AYAs with Advanced Cancer. We will first adapt and iteratively test the existing PRISM based on established guidelines for intervention development. Then, we will conduct a multi-site randomized controlled trial to test the efficacy of a new PRISM for Advanced Cancer (PRISM-AC). Findings will inform the development of larger dissemination studies and standards of AYA end-of-life and palliative care. Ultimately, this research has the potential to reduce the burden of cancer in a highly vulnerable population.
Interventions
Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making
Sponsors
Study design
Eligibility
Inclusion criteria
* Age 12-24 years * Diagnosed with advanced cancer: progressive, recurrent, refractory disease or any diagnosis with estimated overall survival \<50% at least 2 weeks prior to enrollment * Able to speak English * Able to read English or Spanish * Cognitively able to participate in interviews
Exclusion criteria
* Patient Refusal * Parent Refusal (if patient \<18 years-old)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Quality of Life Cancer Module | 3-months | Pediatric Quality of Life (PedsQL) Cancer Module -This scale was designed to assess pediatric cancer-specific health related quality of life. This is a 27 item scale, with each item rated on a 5-point Likert scale where 0=never and 4=almost always. Higher scores represent better health-related quality of life. Scale range is 0-100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) Total Score | 3-months | The Hospital Anxiety and Depression Scale total score is a 14 items scale on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression. The total score is the sum of all 14 items, ranging from 0-42. Higher scores indicate higher total anxiety/depression. |
| Snyder Hope Scale | 3-months | Hope: 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. |
| Connor Davidson Resilience Scale | 3-months | Resilience: The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. This is a 10-item scale ranging from 0-40 where higher scores reflect greater perceived resilience. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Promoting Resilience in Stress Management (PRISM) Resilience Skills Training
Promoting Resilience in Stress Management (PRISM): Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making | 99 |
| Usual Care Standard psychosocial care | 96 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 10 | 5 |
| Overall Study | Lost to Follow-up | 12 | 12 |
| Overall Study | Withdrawal by Subject | 8 | 3 |
Baseline characteristics
| Characteristic | Promoting Resilience in Stress Management (PRISM) | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 16.51 years STANDARD_DEVIATION 3.79 | 16.51 years STANDARD_DEVIATION 3.99 | 16.51 years STANDARD_DEVIATION 3.88 |
| Connor-Davidson Resilience Scale | 27.34 units on a scale STANDARD_DEVIATION 7.41 | 29.05 units on a scale STANDARD_DEVIATION 8.45 | 28.18 units on a scale STANDARD_DEVIATION 7.96 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 37 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 59 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 4 Participants |
| Pediatric Quality of Life Cancer Module | 65.12 units on a scale STANDARD_DEVIATION 15.78 | 63.53 units on a scale STANDARD_DEVIATION 16.16 | 64.34 units on a scale STANDARD_DEVIATION 15.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 22 Participants | 19 Participants | 41 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 58 Participants | 62 Participants | 120 Participants |
| Region of Enrollment United States | 99 participants | 96 participants | 195 participants |
| Sex: Female, Male Female | 43 Participants | 52 Participants | 95 Participants |
| Sex: Female, Male Male | 56 Participants | 44 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 99 | 5 / 96 |
| other Total, other adverse events | 0 / 99 | 0 / 96 |
| serious Total, serious adverse events | 0 / 99 | 0 / 96 |
Outcome results
Pediatric Quality of Life Cancer Module
Pediatric Quality of Life (PedsQL) Cancer Module -This scale was designed to assess pediatric cancer-specific health related quality of life. This is a 27 item scale, with each item rated on a 5-point Likert scale where 0=never and 4=almost always. Higher scores represent better health-related quality of life. Scale range is 0-100.
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Promoting Resilience in Stress Management (PRISM) | Pediatric Quality of Life Cancer Module | 66.89 score on a scale | Standard Deviation 18.07 |
| Usual Care | Pediatric Quality of Life Cancer Module | 68.41 score on a scale | Standard Deviation 18.07 |
Connor Davidson Resilience Scale
Resilience: The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. This is a 10-item scale ranging from 0-40 where higher scores reflect greater perceived resilience.
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Promoting Resilience in Stress Management (PRISM) | Connor Davidson Resilience Scale | 28.05 score on a scale | Standard Deviation 7.94 |
| Usual Care | Connor Davidson Resilience Scale | 27.45 score on a scale | Standard Deviation 10.16 |
Hospital Anxiety and Depression Scale (HADS) Total Score
The Hospital Anxiety and Depression Scale total score is a 14 items scale on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression. The total score is the sum of all 14 items, ranging from 0-42. Higher scores indicate higher total anxiety/depression.
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Promoting Resilience in Stress Management (PRISM) | Hospital Anxiety and Depression Scale (HADS) Total Score | 8.27 score on a scale | Standard Deviation 6.79 |
| Usual Care | Hospital Anxiety and Depression Scale (HADS) Total Score | 9.94 score on a scale | Standard Deviation 7.77 |
Snyder Hope Scale
Hope: 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: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Promoting Resilience in Stress Management (PRISM) | Snyder Hope Scale | 48.06 score on a scale | Standard Deviation 12.15 |
| Usual Care | Snyder Hope Scale | 46.89 score on a scale | Standard Deviation 14.46 |