Trial Outcomes & Findings for The PRISM Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer (NCT NCT03668223)

Last Updated: 2025-12-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

195 participants

Primary outcome timeframe

3-months

Results posted on

2025-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	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	Usual Care Standard psychosocial care
Overall Study STARTED	99	96
Overall Study COMPLETED	69	76
Overall Study NOT COMPLETED	30	20

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Usual Care Standard psychosocial care
Overall Study Death	10	5
Overall Study Lost to Follow-up	12	12
Overall Study Withdrawal by Subject	8	3

Baseline Characteristics

The PRISM Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Promoting Resilience in Stress Management (PRISM) n=99 Participants Resilience Skills Training Promoting Resilience in Stress Management (PRISM): Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making	Usual Care n=96 Participants Standard psychosocial care	Total n=195 Participants Total of all reporting groups
Age, Continuous	16.51 years STANDARD_DEVIATION 3.79 • n=37 Participants	16.51 years STANDARD_DEVIATION 3.99 • n=37 Participants	16.51 years STANDARD_DEVIATION 3.88 • n=74 Participants
Sex: Female, Male Female	43 Participants n=37 Participants	52 Participants n=37 Participants	95 Participants n=74 Participants
Sex: Female, Male Male	56 Participants n=37 Participants	44 Participants n=37 Participants	100 Participants n=74 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=37 Participants	37 Participants n=37 Participants	77 Participants n=74 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=37 Participants	59 Participants n=37 Participants	114 Participants n=74 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=37 Participants	0 Participants n=37 Participants	4 Participants n=74 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=37 Participants	1 Participants n=37 Participants	2 Participants n=74 Participants
Race (NIH/OMB) Asian	5 Participants n=37 Participants	5 Participants n=37 Participants	10 Participants n=74 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Black or African American	9 Participants n=37 Participants	7 Participants n=37 Participants	16 Participants n=74 Participants
Race (NIH/OMB) White	58 Participants n=37 Participants	62 Participants n=37 Participants	120 Participants n=74 Participants
Race (NIH/OMB) More than one race	22 Participants n=37 Participants	19 Participants n=37 Participants	41 Participants n=74 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=37 Participants	2 Participants n=37 Participants	6 Participants n=74 Participants
Region of Enrollment United States	99 participants n=37 Participants	96 participants n=37 Participants	195 participants n=74 Participants
Pediatric Quality of Life Cancer Module	65.12 units on a scale STANDARD_DEVIATION 15.78 • n=37 Participants	63.53 units on a scale STANDARD_DEVIATION 16.16 • n=37 Participants	64.34 units on a scale STANDARD_DEVIATION 15.95 • n=74 Participants
Connor-Davidson Resilience Scale	27.34 units on a scale STANDARD_DEVIATION 7.41 • n=37 Participants	29.05 units on a scale STANDARD_DEVIATION 8.45 • n=37 Participants	28.18 units on a scale STANDARD_DEVIATION 7.96 • n=74 Participants

PRIMARY outcome

Timeframe: 3-months

Outcome measures

Outcome measures
Measure	Promoting Resilience in Stress Management (PRISM) n=69 Participants Resilience Skills Training Promoting Resilience in Stress Management (PRISM): Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making	Usual Care n=76 Participants Standard psychosocial care
Pediatric Quality of Life Cancer Module	66.89 score on a scale Standard Deviation 18.07	68.41 score on a scale Standard Deviation 18.07

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Promoting Resilience in Stress Management (PRISM) n=69 Participants Resilience Skills Training Promoting Resilience in Stress Management (PRISM): Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making	Usual Care n=76 Participants Standard psychosocial care
Hospital Anxiety and Depression Scale (HADS) Total Score	8.27 score on a scale Standard Deviation 6.79	9.94 score on a scale Standard Deviation 7.77

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Promoting Resilience in Stress Management (PRISM) n=69 Participants Resilience Skills Training Promoting Resilience in Stress Management (PRISM): Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making	Usual Care n=76 Participants Standard psychosocial care
Snyder Hope Scale	48.06 score on a scale Standard Deviation 12.15	46.89 score on a scale Standard Deviation 14.46

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Promoting Resilience in Stress Management (PRISM) n=69 Participants Resilience Skills Training Promoting Resilience in Stress Management (PRISM): Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making	Usual Care n=76 Participants Standard psychosocial care
Connor Davidson Resilience Scale	28.05 score on a scale Standard Deviation 7.94	27.45 score on a scale Standard Deviation 10.16

Adverse Events

Promoting Resilience in Stress Management (PRISM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 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

Dr. Abby Rosenberg

Dana Farber Cancer Institute

Phone: 617-632-5286

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place