Promoting resilience in adolescents and young adults with cancer: Results from the PRISM randomized controlled trial
Open accessAbstract
Background: Adolescents and young adults (AYAs) with cancer are at risk for poor psychosocial outcomes. This study aimed to determine whether a novel intervention targeting resilience resources would improve patient‐reported resilience, quality of life, and psychological distress. Methods: In this parallel, phase 2 randomized controlled trial, English‐speaking AYAs (12‐25 years old) with cancer were randomized to the Promoting Resilience in Stress Management (PRISM) intervention or usual care (UC). PRISM is a brief, skills‐based intervention targeting stress management, goal setting, cognitive reframing, and meaning making. Participants completed surveys at enrollment and 6 months. Mixed effects regression models evaluated associations between PRISM and the primary outcome (10‐item Connor‐Davidson Resilience Scale scores) and secondary outcomes (generic and cancer‐related quality of life [Pediatric Quality of Life modules], psychological distress [Kessler‐6], and anxiety/depression [Hospital Anxiety and Depression]) at 6 months. Results: Ninety‐two AYAs were enrolled, were randomized, and completed baseline surveys (48 in the PRISM group and 44 in the UC group); 73% were 12 to 17 years old, and 62% had leukemia or lymphoma. Attrition was primarily due to medical complications and/or death; 36 PRISM participants and 38 UC participants completed 6‐month surveys. PRISM was associated with improved resilience (+3.0 points; 95% confidence interval [CI], 0.5‐5.4; P = .02) and cancer‐specific quality of life (+9.6; 95% CI, 2.6‐16.7; P = .01) and reduced psychological distress (–2.1; 95% CI, –4.1 to –0.2; P = .03) but not generic quality of life (+7.2; 95% CI, –0.8 to 15.2; P = .08). Although anxiety was similar between the groups, 2 PRISM participants (6%) and 8 UC participants (21%) met the criteria for depression at 6 months (odds ratio, 0.09; 95% CI, 0.01‐1.09; P = .06). Conclusions: PRISM was associated with improved psychosocial outcomes in comparison with UC, suggesting that brief, skills‐based interventions for AYAs may provide a benefit.
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TL;DR
In the PRISM randomized controlled trial, a brief skills-based intervention for adolescents and young adults with cancer was associated with improved patient-reported resilience, cancer-specific quality of life, and psychological distress compared with usual care at 6 months. Depression rates were lower among PRISM participants but the difference was not statistically significant.
Key findings
Among 92 enrolled AYAs (48 PRISM, 44 usual care), PRISM was associated with improved resilience (+3.0 points; 95% CI, 0.5-5.4; P = .02), improved cancer-specific quality of life (+9.6; 95% CI, 2.6-16.7; P = .01), and reduced psychological distress (−2.1; 95% CI, −4.1 to −0.2; P = .03).
- Generic quality of life did not significantly improve (+7.2; 95% CI, −0.8 to 15.2; P = .08).
- Anxiety was similar between groups: 6 PRISM participants (17%) and 10 usual care participants (26%) met criteria (OR, 0.36; 95% CI, 0.07-1.96), whereas depression was 2 PRISM participants (6%) and 8 usual care participants (21%) (OR, 0.09; 95% CI, 0.01-1.09; P = .06).
- At enrollment, 73% were 12 to 17 years old and 62% had leukemia or lymphoma; 43 of 48 PRISM participants (90%) received all 4 main sessions, and attrition was primarily due to medical complications and/or death.
Methods
Phase 2, parallel, 1:1 randomized controlled trial at Seattle Children's Hospital between January 2015 and October 2016; eligible participants were English-speaking AYAs aged 12 to 25 years with new cancer diagnosed 1 to 10 weeks before enrollment and receiving systemic chemotherapy, or with progressive/recurrent/refractory cancer at any time before enrollment; patients with preexisting or cancer-associated cognitive disabilities were excluded.
- One hundred AYAs were randomized (50 usual care, 50 PRISM); 92 completed baseline surveys (44 usual care, 48 PRISM), and 6-month surveys were completed by 38 usual care and 36 PRISM participants.
- Primary outcome was patient-reported resilience at 6 months (CDRISC-10); secondary outcomes included generic and cancer-specific quality of life (PedsQL), psychological distress (Kessler-6), and anxiety/depression (HADS).
- Primary intention-to-treat analysis used unadjusted linear mixed effects regression with patient-level random intercepts and slopes for continuous outcomes and mixed effects logistic regression for binary anxiety/depression outcomes; sensitivity analyses adjusted for sex, race/ethnicity, first language, and history of advanced cancer were unchanged; testing was 2-sided at α = .05 without correction for multiple comparisons.
Limitations
Stated: the trial was conducted at a single large academic pediatric-based AYA oncology center with a multidisciplinary psychosocial usual care team, so results may not generalize to smaller, community-based, or adult oncology centers; staff may have been aware of PRISM content; more usual care participants declined continued participation before baseline; only English-speaking patients were included; chance imbalance occurred in sex and first language; the CDRISC-10 may not exclusively reflect ability to harness resilience resources; the study could not delineate PRISM's active ingredients or dose effect, track real-life skill uptake, or assess durability; and the lack of an active control means social contact may have contributed to effects.
- Stated: the sample size may have been too small to detect subtle biases, and cultural differences in perceptions of resilience warrant further investigation.
- Evident from the text: the 6-month binary outcome analyses were based on only 74 participants, and no correction for multiple comparisons was applied, so the anxiety and depression findings are non-significant trends that should be interpreted cautiously.
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Claims the paper makes
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- Findingown data
Of the 74 participants with 6-month data, anxiety criteria were met by 6 PRISM participants (17%) and 10 usual-care participants (26%) (OR, 0.36; 95% CI, 0.07-1.96).
“Among the 74 with 6-month survey data, 6 PRISM participants (17%) and 10 UC participants (26%) met criteria for anxiety (odds ratio, 0.36; 95% CI, 0.07-1.96)”
Quote in the paperSubstantial claim - Findingown data
At 6 months, the PRISM group did not show a significant increase in generic quality of life (7.2 points; 95% CI, -0.8 to 15.2; P = .08).
“but not generic quality of life (+7.2;95% CI, -0.8 to 15.2; P = .08)”
- Also stated in: § RESULTS · plain
“but not higher generic quality of life (+7.2;95% CI, -0.8 to 15.2; P = .08;Table 3)”
Quote in the paperNot a substantial claim - Also stated in: § RESULTS · plain
- Findingown data
Of the 74 participants with 6-month data, depression criteria were met by 2 PRISM participants (6%) and 8 usual-care participants (21%) (OR, 0.09; 95% CI, 0.01-1.09).
“whereas 2 PRISM participants (6%) and 8 UC participants (21%) met criteria for depression (odds ratio, 0.09; 95% CI, 0.01-1.09).”
- Also stated in: § Abstract · plain
“2 PRISM participants (6%) and 8 UC participants (21%) met the criteria for depression at 6 months (odds ratio, 0.09; 95% CI, 0.01-1.09;P = .06)”
- Also stated in: § DISCUSSION · hedged
“Patients who received PRISM showed a trend toward lower rates of depression.”
Quote in the paperSubstantial claim - Also stated in: § Abstract · plain
- Findingown data
Effect sizes were small to moderate.
“Effect sizes were small to moderate.”
Quote in the paperNot a substantial claim - Findingown data
Among the 92 participants (44 usual care and 48 PRISM), there were no differences between groups in clinical or demographic characteristics except for sex and first language.
“Among the remaining 92 participants (44 UC participants and 48 PRISM participants), there were no differences between the groups with respect to clinical or demographic characteristics except for sex and first language (Table 2).”
Quote in the paperNot a substantial claim
- Findingown data
Attrition between baseline and 6-month follow-up was predominantly due to medical complications or death (4 usual-care participants [9%] and 10 PRISM participants [21%]; Fisher's exact P = .25).
“Reasons for attrition between the baseline and 6-month follow-up surveys were predominantly medical complications or death (4 UC participants [9%] and 10 PRISM participants [21%]; Fisher's exact P = .25).”
Quote in the paperNot a substantial claim - Findingown data
At 6 months, psychological distress was 2.1 points lower in the PRISM group (95% CI, -4.1 to -0.2).
“reduced psychological distress (-2.1; 95% CI, -4.1 to -0.2; P = .03)”
- Also stated in: § RESULTS · plain
“and lower psychological distress (-2.1; 95% CI, -4.1 to -0.2)”
Quote in the paperSubstantial claim - Also stated in: § RESULTS · plain
- Findingown data
There were no demographic differences between eligible patients who did and did not enroll.
“There were no demographic differences between eligible patients who did and did not enroll.”
Quote in the paperNot a substantial claim - Findingnone given
There were no adverse events related to study participation.
“Furthermore, there were no adverse events related to study participation.”
Quote in the paperNot a substantial claim - Findingown data
At 6 months, cancer-specific quality of life was 9.6 points higher in the PRISM group (95% CI, 2.6-16.7).
“cancer-specific quality of life (+9.6;95% CI, 2.6-16.7;P = .01)”
- Also stated in: § RESULTS · plain
“and cancer-specific quality of life (+9.6;95% CI, 2.6-16.7)”
Quote in the paperSubstantial claim - Also stated in: § RESULTS · plain
- Findingown data
At the 6-month point, the PRISM arm showed a 3.0-point increase in self-reported resilience (95% CI, 0.5-5.4).
“PRISM was associated with improved resilience (+3.0 points; 95% confidence interval [CI], 0.5-5.4;P = .02)and”
- Also stated in: § RESULTS · plain
“At 6 months, PRISM was associated with higher patient-reported resilience (+3.0 points; 95% confidence interval [CI], 0.5-5.4)”
Quote in the paperSubstantial claim - Also stated in: § RESULTS · plain
- Findingown data
At 6 months, PRISM compared with usual care was associated with a 2.1-point decrease in Kessler-6 global psychological distress scores (β=-2.1, 95% CI -4.1 to -0.2, P=.03).
“Global psychological | 2.3 | 0.5 | -2.1 (-4.1 to -0.2) .03”
Quote in the paperSubstantial claim - Findingown data
At 6 months, PRISM compared with usual care was associated with a 9.6-point increase in PedsQL Cancer Module quality-of-life scores (β=9.6, 95% CI 2.6-16.7, P=.01).
“Cancer-specific | 9.3 | 0.5 | 9.6 (2.6-16.7) | .01”
Quote in the paperSubstantial claim - Findingown data
At 6 months, PRISM compared with usual care was associated with a 7.2-point increase in PedsQL SF-15 generic quality-of-life scores (β=7.2, 95% CI -0.8 to 15.2, P=.08).
“Generic quality of life | 7.2 | 0.4 | 7.2 (-0.8 to 15.2) | .08”
Quote in the paperNot a substantial claim - Findingown data
At 6 months, PRISM compared with usual care had an odds ratio of 0.36 for anxiety (HADS-A >7; 95% CI 0.07-1.96, P=.24).
“Anxiety (HADS-A score > 7) | | 0.36 (0.07-1.96) | .24”
Quote in the paperNot a substantial claim - Findingown data
At 6 months, PRISM compared with usual care had an odds ratio of 0.09 for depression (HADS-D >7; 95% CI 0.01-1.09, P=.06).
“Depression (HADS-D score > 7) | | 0.09 (0.01-1.09) | .06”
Quote in the paperNot a substantial claim - Findingown data
Relative to usual care, PRISM was linked to clinically significant psychosocial health improvements with moderate effect sizes.
“Compared with UC, PRISM was associated with clinically significant improvements in psychosocial health with moderate effect sizes.”
Quote in the paperSubstantial claim - Findingown data
At 6 months, PRISM compared with usual care was associated with a 3.0-point increase in CDRISC-10 resilience scores (β=3.0, 95% CI 0.5-5.4, P=.02).
“Resilience | 3.0 | 0.4 | 3.0 (0.5-5.4) | .02”
Quote in the paperSubstantial claim - Premisecitation
Cancer in adolescents and young adults disrupts normal developmental experiences such as identity formation and pursuit of educational and vocational goals.
“in part because cancer disrupts normal developmental experiences such as the establishment of personal, social, and sexual identity and the pursuit of educational and vocational goals.[1][2][3][4][5]”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [1][2][3][4][5]
Not checked in the free run.
- Premisecitation
Adolescents and young adults with cancer are at elevated risk for poor psychosocial outcomes.
“Adolescents and young adults (AYAs) with cancer are at risk for poor psychosocial outcomes.”
- Also stated in: § INTRODUCTION · plain
“Adolescents and young adults (AYAs; 12-25 years old) with cancer are at risk for poor psychosocial outcomes”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [1][2][3][4][5]
Not checked in the free run.
- Also stated in: § INTRODUCTION · plain
- Premisecitation
Few interventions for adolescents and young adults with cancer have been evaluated in randomized controlled trials.
“few interventions have been evaluated in randomized controlled trials.23”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [23] source
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- Premisecitation
More than one-third of adolescents and young adults decline traditional cognitive behavioral therapy.
“More than one-third decline traditional cognitive behavioral therapy (CBT)”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [21] source
Not checked in the free run.
- Premisecitation
An additional one-third of adolescents and young adults discontinue cognitive behavioral therapy because of its typical time commitment.
“and an additional one-third discontinue participation because of CBT's typical time commitment.21”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [21] source
Not checked in the free run.
- Premisecitation
The need for targeted psychosocial care for adolescents and young adults with cancer is well established.
“Although the need for targeted psychosocial care for AYAs with cancer is well established”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [23] source
Not checked in the free run.
- Study design and conductreasoning
Only English-speaking patients were enrolled.
“We included only English-speaking patients because PRISM has been validated only in English.”
Quote in the paperSubstantial claim- Rests on an assumption: PRISM has been validated only in English.
- Interpretationreasoning
High engagement might result from PRISM's inclusion of stakeholder-identified content and format preferences.
“These observations may be due to the fact that PRISM's design incorporates stakeholder-identified preferences for content and format.”
Quote in the paperNot a substantial claim0 of 2 sources checked - Interpretationcitation
The enrollment rate might be explained by the large academic pediatric AYA oncology center, where research participation is frequent.
“Our enrollment may be attributable to our large, academic, pediatric-based AYA oncology center, where participation in clinical research is common.40”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [40] source
Not checked in the free run.
- Interpretationreasoning
AYAs who speak English as a second language may not represent all non-English speakers.
“yet this group is not necessarily representative of non-English speakers.”
Quote in the paperNot a substantial claim - Interpretationown data
Short, skills-focused interventions may benefit adolescents and young adults.
“suggesting that brief, skills-based interventions for AYAs may provide a benefit.”
Quote in the paperSubstantial claim- Rests on an assumption: Adolescents and young adults may avoid developing maladaptive behaviors through preventive learning.
- Study design and conductown data
Only one PRISM participant (2%) did not complete the baseline survey after randomization.
“After randomization, only 1 PRISM participant (2%) failed to complete the baseline survey.”
Quote in the paperNot a substantial claim - Interpretationreasoning
Findings might not apply to smaller, community-based, or adult oncology settings.
“Results may not be generalizable to smaller, community-based, or adult oncology centers.”
Quote in the paperNot a substantial claim - Interpretationnone given
The usual care condition includes a multidisciplinary psychosocial team that may not exist in other settings.
“Similarly, our UC involves a multidisciplinary psychosocial team, which may not be available elsewhere.”
Quote in the paperSubstantial claim - Study design and conductown data
Of the 48 remaining PRISM participants, 43 (90%) finished all four main intervention sessions.
“Forty-three of the remaining 48 participants (90%) completed all 4 main intervention sessions.”
Quote in the paperNot a substantial claim - Interpretationreasoning
PRISM's effects could differ in other settings.
“PRISM's benefit may, therefore, be different elsewhere.”
Quote in the paperNot a substantial claim - Premisecitation
The PRISM intervention design includes content and format preferences identified by stakeholders.
“PRISM's design incorporates stakeholder-identified preferences for content and format.37,38”
Quote in the paperNot a substantial claim0 of 2 sources checked - Interpretationown data
Compared with usual care, PRISM was linked to better psychosocial outcomes.
“PRISM was associated with improved psychosocial outcomes in comparison with UC”
Quote in the paperSubstantial claim - Study design and conductown data
More usual care participants than PRISM participants withdrew after randomization but before completing the baseline survey.
“Despite our high enrollment rate, more UC participants than PRISM participants declined continued participation after randomization and before baseline survey completion.”
Quote in the paperNot a substantial claim - Interpretationreasoning
CDRISC-10 scores might not solely capture an AYA's capacity to use resilience resources.
“It may not exclusively reflect an AYA's ability to harness resilience resources”
Quote in the paperSubstantial claim - Interpretationreasoning
PRISM is a promising method for improving outcomes in a vulnerable, high-risk population.
“PRISM represents a promising approach to improving outcomes in an otherwise vulnerable and high-risk population.”
Quote in the paperSubstantial claim- The authors state this as an assumption: AYAs, especially those with serious illness, may have underdeveloped resources.
- The authors state this as an assumption: PRISM's mechanism of action is to bolster these resources and, in turn, enable AYA well-being.
- Interpretationreasoning
CDRISC-10 scores do not have clear clinical meaning.
“nor do CDRISC-10 scores clearly translate into meaningful clinical implications.”
Quote in the paperSubstantial claim - Study design and conductreasoning
The sample may have been too small to detect small biases.
“our sample size may have been too small to detect subtle biases.”
Quote in the paperNot a substantial claim - Premisecitation
Social support is an important determinant of AYA patient-reported well-being.
“because social support is a key factor of AYA patient-reported well-being.45”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [45] source
Not checked in the free run.
- Premisecitation
Meta-analyses indicate that even small effects from positive psychology interventions relate to meaningful patient-centered outcomes.
“These findings are promising because meta-analyses suggest that even small effect sizes of positive psychology interventions are associated with meaningful patient-centered outcomes.46”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [46] source
Not checked in the free run.
- May combine two claims. 26
- Classified as probably not a substantial claim. 25
May combine two claims.
Findingown dataExploratory analyses indicated different score trajectories: usual-care participants' resilience and quality-of-life scores declined or stayed flat, while PRISM participants' scores rose.
“Exploratory analyses suggested divergent trajectories of instrument scores (Fig. 2).For example, resilience and quality-of-life scores among UC participants went down or remained unchanged, whereas PRISM participants' scores went up.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataThirty-eight usual-care participants and 36 PRISM participants completed 6-month surveys.
“Thirty-eight UC participants and 36 PRISM participants completed 6-month surveys (median completion time, 8 days after the 6-month due date; interquartile range, 8-17 days).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataSix usual-care participants (12%) did not complete baseline surveys, and one PRISM participant (2%) elected not to complete the baseline survey.
“Six UC participants (12%) did not complete the baseline surveys (5 electively and 1 on account of medical complications severely impairing her cognition).One PRISM participant (2%) elected not to complete the baseline survey.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataNo PRISM participants reported high distress.
“No PRISM participants reported high distress.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataDuring the 22-month enrollment period, 483 patients were assessed, 130 were eligible, and 100 (77%) were enrolled and randomized 50 to usual care and 50 to PRISM.
“During the 22-month enrollment period, we assessed 483 patients for eligibility (Fig. 1).Of 130 eligible AYAs, 100 (77%) were enrolled, and they were randomized (50 to UC and 50 to PRISM).”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataChanges in resilience and cancer-specific quality of life met or exceeded the minimal clinically important difference.
“Changes in resilience and cancer-specific quality of life met or exceeded the MCID.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataAll 48 PRISM participants received at least 1 session, 43 (90%) received all 4 main sessions, and 40 (83%) opted in for coming together.
“All 48 PRISM participants received at least 1 session, 43 (90%) received all 4 main sessions, and 40 (83%) opted in for coming together (Fig. 1).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
PremisecitationResilience, defined as harnessing resources to sustain physical and emotional well-being under significant stress, is a promising approach.
“resilience (defined as the process of harnessing resources to sustain physical and emotional well-being in the face of significant stress) represents a promising approach.14”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [14] source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationIn older adults with cancer, goal seeking and problem solving improve psychosocial health.
“goal seeking and problem solving improve psychosocial health, 16”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [16] source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationThese challenges may lead to underemployment, excessive medical expenditures, and productivity losses.
“These challenges may translate into underemployment, excessive medical expenditures, and significant corresponding productivity losses.9”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [9] source
Not checked in the free run.
May combine two claims.
PremisecitationPRISM is a novel, developmentally appropriate, brief, skills-based psychosocial intervention targeting resilience resources.
“we developed and demonstrated the feasibility and acceptability of a novel, developmentally appropriate, brief, skills-based psychosocial intervention targeting resilience resources: Promoting Resilience in Stress Management (PRISM).24,25”
Quote in the paperSubstantial claim0 of 2 sources checkedMay combine two claims.
PremisecitationInadequate psychosocial support and underdeveloped skills for navigating adversity may worsen these challenges.
“Inadequate psychosocial support and underdeveloped skills for navigating adversity may exacerbate these challenges.7,[10][11][12]”
Quote in the paperSubstantial claim0 of 1 sources checked- cites 7,[10][11][12]
Not checked in the free run.
Classified as probably not a substantial claim.
PremisecitationImpaired physical, social, and emotional health during and after cancer therapy is common.
“Impaired physical, social, and emotional health during and after cancer therapy are common.7,8”
Quote in the paperSubstantial claim0 of 2 sources checkedProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationIn older adults with cancer, mindfulness improves quality of life.
“and mindfulness improves quality of life.17”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [17] source
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May combine two claims.
PremisecitationReductions in stress and distress improve immune function and reduce morbidity and mortality.
“Reductions in stress and distress improve immune function and reduce morbidity and mortality.[18][19][20]”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [18][19][20]
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May combine two claims.
PremisecitationAdolescent and young adult cancer survivors report more psychological distress and fewer positive health beliefs than younger pediatric or older adult cancer patients.
“AYA cancer survivors report greater psychological distress and fewer positive health beliefs than younger pediatric or older adult counterparts.6”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [6] source
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May combine two claims.
PremisecitationAdolescents and young adults learn and communicate differently from younger and older patients, requiring age-targeted language and educational methods.
“AYAs learn and communicate differently than younger and older patients, and this necessitates age-targeted language and educational methods.22”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [22] source
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Probably not a substantial claim: may not pass S2 (checkable).
PremisecitationPromoting resilience resources such as stress management, goal setting, cognitive reframing, and meaning making may be valuable.
“Promoting resilience resources (eg, skills in stress management, goal setting, cognitive reframing, and meaning making) may be valuable.15”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [15] source
Not checked in the free run.
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PremisecitationIn older adults with cancer, stress management reduces depression.
“among older adults with cancer, stress management reduces depression, 16”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [16] source
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PremisecitationFewer than 50% of American adolescents and young adults with cancer enroll in clinical trials.
“Fewer than 50% of American AYAs with cancer enroll in clinical trials.35”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [35] source
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Study design and conductown dataThe primary intention-to-treat analysis included all patients who completed baseline surveys.
“In this primary intention-to-treat analysis, data were analyzed and reported as planned.We included data from all patients who completed baseline surveys.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationPRISM's feasibility and acceptability have been demonstrated.
“we developed and demonstrated the feasibility and acceptability of a novel, developmentally appropriate, brief, skills-based psychosocial intervention targeting resilience resources: Promoting Resilience in Stress Management (PRISM).24,25”
Quote in the paperSubstantial claim0 of 2 sources checkedProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataSensitivity analyses adjusted for sex, race/ethnicity, first language, and history of advanced cancer; estimates were unchanged, so unadjusted models were reported.
“Sensitivity analyses were adjusted for patient sex, race/ethnicity, first language, and history of advanced cancer.Because the estimates were unchanged, we report unadjusted models.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationResearch participation is frequent at large academic pediatric AYA oncology centers.
“where participation in clinical research is common.40”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [40] source
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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenAll testing was two-sided at a .05 significance level without correction for multiple comparisons.
“All testing was 2-sided and conducted at a .05significance level without correction for multiple comparisons.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationAllowing personal narrative sharing is linked to AYA participation in clinical research.
“this is another variable associated with AYA engagement in clinical research.39”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [39] source
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May combine two claims.
Study design and conductown dataIt is not possible to determine if those who dropped out differed in baseline psychological characteristics or how attrition influenced the results.
“We cannot determine whether this group had different baseline psychological characteristics, nor can we assess how attrition affected study findings.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationQualitative analyses suggest that stress from a new cancer diagnosis limits enrollment, while directed patient engagement in consent discussions facilitates it.
“Qualitative analyses suggest that the stress associated with a new cancer diagnosis limits enrollment, whereas directed patient engagement in consent discussions facilitates it.36”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [36] source
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Study design and conductown dataParticipants completed age-validated instruments at enrollment and 6 months.
“All participants were invited to complete a survey consisting of AYA age-validated instruments upon enrollment (before any PRISM sessions, where relevant) and 6 months later.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
InterpretationreasoningThis attrition might stem from usual care participants perceiving no benefit from the control condition.
“This may be because they perceived a lack of benefit from the control arm.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductcitationPRISM was administered by trained bachelor's-level nonclinical staff who received at least 8 hours of standardized training including mock sessions with role playing.
“PRISM was administered by trained, bachelor's degreelevel nonclinical staff.25 All interventionists received ≥8 hours of standardized training, including mock sessions with role playing.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [25] source
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InterpretationreasoningThe 77% enrollment rate among eligible patients exceeded rates reported in published studies, possibly because patients were approached at least 2 weeks after diagnosis and directly engaged in consent discussions.
“Our enrollment rate of 77% among eligible patients was higher than rates in published studies, perhaps because we waited to approach patients until at least 2 weeks after their diagnosis and directly engaged them in consent discussions.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductown dataRandomization used permuted blocks of various sizes, was stratified by age, and staff were blinded to the randomization scheme until after enrollment.
“The randomization algorithm was constructed with permuted blocks of various sizes; schedules were stratified by age (12-17 vs 18-25 years) because intervention materials were written at the developmental levels of these 2 age groups.Staff were blinded to the randomization scheme until after enrollment.”
Quote in the paperSubstantial claimMay combine two claims.
Study design and conductown dataFidelity was assessed by audio-recording all PRISM sessions and scoring the first 5 sessions and 1 of any 5 randomly selected sessions with a standardized tool; no remediation was necessary.
“All PRISM sessions were audio-recorded.For each interventionist, the first 5 sessions and 1 of any 5 randomly selected sessions were scored for fidelity with a standardized tool.25,27 Although our protocol included processes to retrain interventionists if needed, no remediation was necessary.”
Quote in the paperNot a substantial claim0 of 2 sources checkedProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenPRISM is manualized with standardized protocols outlining training, delivery, and fidelity maintenance.
“It is manualized (eg, it has been standardized through comprehensive protocols outlining training, delivery, and maintenance of fidelity).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationResilience measured by the Connor-Davidson Resilience Scale has been linked to various traits, states, processes, and outcomes, including hardiness, affect, coping, and life satisfaction.
“However, the construct of resilience, as assessed by the Connor Davidson Resilience Scale, has been associated with variable traits, states, processes, and outcomes such as hardiness, affect, coping, and life satisfaction.43”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [43]
Not checked in the free run.
May combine two claims.
Study design and conductown dataThe study did not monitor real-world use of PRISM skills, so uptake cannot be measured.
“We did not track the real-life application of PRISM skills, so we cannot measure its uptake.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataLinear models used 92 participants with baseline data, while logistic models used 74 participants with 6-month data.
“Linear models were based on 92 participants with baseline data; logistic models were based on 74 participants with 6-month data.”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductown dataSince 90% of PRISM recipients attended all four main sessions, the study cannot identify PRISM's active components or a dose-response effect.
“Because 90% of PRISM recipients received all 4 main sessions, we cannot delineate PRISM's active ingredients or a dose effect.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
InterpretationcitationPRISM's effect might come from the social aspect of its delivery rather than its content.
“It is possible that PRISM's impact is due to the social aspect of its delivery, rather than its content”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductown dataRandomly, the usual care group had more participants who were female and/or spoke English as a second language than the PRISM group.
“By chance, more UC participants than PRISM participants spoke English as a second language and/or were female.”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductreasoningThe study cannot evaluate how long outcome improvements last or whether PRISM skills persist.
“We cannot assess the durability of outcome improvements or the persistence of PRISM-developed skills.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
InterpretationreasoningPRISM's observed effectiveness might be due to greater responsiveness among primary English speakers or young men.
“PRISM's apparent efficacy may be because primary English speakers or young men are more responsive.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Traditional cognitive behavioral therapy is designed for patients with maladaptive coping.
“Finally, CBT is designed for patients with maladaptive coping; AYAs may avoid the development of maladaptive behaviors through preventive learning.”
The paper relies on this without support.
Adolescents and young adults may avoid developing maladaptive behaviors through preventive learning.
“Finally, CBT is designed for patients with maladaptive coping; AYAs may avoid the development of maladaptive behaviors through preventive learning.”
The authors state this as an assumption.
AYAs, especially those with serious illness, may have underdeveloped resources.
“we postulate that AYAs, especially those with serious illness, may have underdeveloped resources.”
The authors state this as an assumption.
PRISM's mechanism of action is to bolster these resources and, in turn, enable AYA well-being.
“PRISM's proposed mechanism of action is to bolster these resources and, in turn, enable AYA well-being.”
The paper relies on this without support.
PRISM has been validated only in English.
“because PRISM has been validated only in English.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The PRISM clinical trial showed statistically significant improvements in patient-reported resilience and cancer-specific quality of life, as well as reduced psychological distress, among adolescents and young adults after cancer treatment aged 12-25 years (N=100).
“A clinical trial testing the efficacy of the PRISM skills intervention compared to usual care among adolescents and young adults after cancer treatment, aged 12-25 years (N=100), showed statistically significant improvements in patient‐reported resilience and cancer‐specific quality of life, as well as reduced psychological distress [29].”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Cancer-specific quality-of-life MCID does not match the stated calculation
MinorTable 2 gives a cancer-specific quality-of-life baseline SD of 16.3. Half of that is 8.15, not the MCID of 9.3 reported in Table 3.
Reported 9.3 · recomputed 8.15
“| Cancer-specific | 9.3 | 0.5 | 9.6 (2.6-16.7) | .01 |”
Overall nonwhite percentage is understated
MinorThe table lists 34 nonwhite participants among 92 overall, or approximately 37%, rather than 36%.
Reported 36 · recomputed 36.956522
“| Nonwhite race, No. (%) | 19 (43) | 15 (31) | 34 (36) |”
PRISM-group CNS percentage is overstated
MinorThree of 48 PRISM participants is 6.25%, which rounds to 6% at the table's whole-percentage precision, not 7%.
Reported 7 · recomputed 6.25
“| CNS, No. (%) | 3 (7) | 3 (7) | 6 (7) |”
Generic quality-of-life MCID does not match the stated calculation
MinorThe paper defines MCID as half the pooled baseline standard deviation. Table 2 gives a generic quality-of-life baseline SD of 18.6, making the MCID 9.3 rather than the reported 7.2.
Reported 7.2 · recomputed 9.3
“| Generic quality of life | 7.2 | 0.4 | 7.2 (-0.8 to 15.2) | .08 |”
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Self-citation
Flagged first, then by citations
Research works printed but not linked: 1
- Davidson J, 2010, Connor‐Davidson Resilience Scale Manual
Cited by
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Hope in the context of life-threatening illness and the end of life
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Self-citationMultilevel Characteristics of Cumulative Symptom Burden in Young Survivors of Childhood Cancer
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A Structural Racism Framework to Guide Health Equity Interventions in Pediatric Oncology
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Poor Mental Health Among Survivors of Childhood Cancer—Risk Factors and a Call for Intervention
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Self-citationPediatric Medical Traumatic Stress in Individuals With Craniofacial Conditions
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Self-citation
- Authors
- Rosenberg, A. R., Bradford, M. C., McCauley, E., Curtis, J. R., Wolfe, J., Baker, K. S., & Yi‐Frazier, J. P.
- Affiliations
- Seattle Children's Hospital (US)
- Seattle Children's Research Institute (US)
- University of Washington (US)
- Boston Children's Hospital (US)
- Corresponding author
- Rosenberg, Abby R.
- ORCID
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2018-09-19
- Volume
- 124
- Issue
- 19
- Pages
- 3909-3917
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- OpenAlex
- W2889985123
- Semantic Scholar
- 39e1761eb0018edd597bc57f0b1459e063402656
- Cited by
- 215
- References
- 45
- Citations by year
- 2026: 18 · 2025: 27 · 2024: 35 · 2023: 36 · 2022: 29 · 2021: 32 · 2020: 20 · 2019: 15 · 2018: 2
- FWCI
- 19.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Cancer (publishedVersion)
- PubMed (publishedVersion)
- Funders
- CureSearch for Children's Cancer (KL2TR000421)
- National Institutes of Health (KL2TR000421)
- National Cancer Institute (L40 CA170049)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Childhood Cancer Survivors' Quality of Life
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Social Sciences › Psychology › Clinical Psychology › Resilience and Mental Health
- Keywords
- adolescent and young adult cancer, resilience, psychosocial interventions, stress management, quality of life, psychological distress, anxiety, depression, cognitive reframing, meaning-making, goal setting, leukemia, lymphoma, psychosocial outcomes, Kessler-6, Connor-Davidson Resilience Scale
- MeSH terms
- Adolescent, Adult, Child, Counseling, Female, Humans, Male, Neoplasms, Patient Education as Topic, Psychotherapy, Stress, Psychological, Treatment Outcome, Age of Onset, Resilience, Psychological, Young Adult
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