Dataset Information

Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care.

ABSTRACT:

Objective

Adolescents and young adults (AYAs) with cancer are at high risk of negative psychosocial outcomes. Promoting Resilience in Stress Management (PRISM), a novel, brief, skill-based intervention, has demonstrated efficacy in improving psychosocial well-being for AYAs. We utilized data from a recent randomized trial of PRISM versus usual care (UC) to categorize and explore group differences in change trajectories of patient reported outcomes (PROs) over time.

Methods

One hundred English-speaking AYAs (aged 12-25 years old) with cancer were randomized to PRISM versus UC. At enrollment and 6 months later, AYAs completed validated PROs measuring resilience (Connor-Davidson Resilience Scale [CDRISC-10]), hope (Hope Scale), benefit finding (Benefit and Burden Scale for Children), cancer-specific quality of life (Pediatric Quality of Life [PedsQL] Cancer Module), and distress (Kessler-6). Patient response trajectories were categorized as "improved," "consistently well," "consistently at risk," or "deteriorated" using minimal clinically important differences (MCIDs) or established measure cutoffs for all PROs. Positive response trajectories consisted of the first two categories ("improved" and "consistently well"), and negative response trajectories consisted of the latter two categories ("consistently at risk" and "deteriorated").

Results

Across all PROs, more patients in the PRISM arm "improved" in psychosocial well-being over time, and fewer PRISM recipients "deteriorated" over time. Across all PROs, a greater proportion of PRISM participants (vs UC) experienced positive response trajectories. Across all PROs, a greater proportion of UC participants experienced negative response trajectories.

Conclusions

PRISM shows evidence of both a prevention effect and an intervention effect. Thus, PRISM may serve as a viable prevention and early intervention model for psychosocial care.

SUBMITTER: Lau N

PROVIDER: S-EPMC7307312 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care.

Lau Nancy N Bradford Miranda C MC Steineck Angela A Junkins Courtney C CC Yi-Frazier Joyce P JP McCauley Elizabeth E Rosenberg Abby R AR

Psycho-oncology 20190514 7

<h4>Objective</h4>Adolescents and young adults (AYAs) with cancer are at high risk of negative psychosocial outcomes. Promoting Resilience in Stress Management (PRISM), a novel, brief, skill-based intervention, has demonstrated efficacy in improving psychosocial well-being for AYAs. We utilized data from a recent randomized trial of PRISM versus usual care (UC) to categorize and explore group differences in change trajectories of patient reported outcomes (PROs) over time.<h4>Methods</h4>One hun ...[more]

PMID: 31037789

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Project description:Children who receive therapeutic feeding for wasting treatment but do not reach the anthropometric definitions of recovery (usually within 12-16 weeks) are categorised as 'non-responders' and considered as treatment failures. We conducted a pooled analysis to explore the growth trajectories of non-responders and the appropriateness of the definition of 'non-response'. We pooled 14 studies of children aged 6-59 months receiving treatment for wasting. We included children classified by their studies as recovered or as non-responders. Observing the pooled data of non-responders' mid-upper arm circumference (MUAC), weight, weight-for-age z-score, weight-for-height z-score and daily weight gain rate, we found that the first quartile differentiated those who did not grow at all versus those that demonstrated some growth. We therefore defined 'low growth non-responders' as < 25th percentile anthropometric gain between admission and exit using the non-responders' pooled study data, and 'high growth non-responders' as ≥ 25th percentile gain. We plotted the growth trajectories of MUAC-, weight- and height-related indices of the recovered, high growth and low growth non-responder groups over time using mixed effects generalised additive models. We compared age, sex and anthropometric characteristics of the three groups and explored predictors of non-response category using a multivariate multinomial logistic regression model. For all outcomes, the high growth non-responders started with a worse anthropometric status compared to those who recovered, but then tracked along a near-parallel growth trajectory. The low growth non-responders showed limited growth throughout treatment. High growth non-responders are better viewed as 'delayed responders' and may need to be kept longer under treatment to recover and reduce the risks from early discharge. Low growth non-responders are the true treatment failures and should be referred for further investigations as quickly as possible. In conclusion, non-responders are not a homogenous group; ~75% of them respond well to treatment and ~25% are treatment failures.

Project description:Background: Parents experience high distress following their child's diagnosis of cancer. We previously tested two delivery models (group and one-on-one) of the "Promoting Resilience in Stress Management for Parents" (PRISM-P) intervention in a randomized trial: one-on-one delivery improved resilience and benefit finding at three months when compared to usual care (UC). Objective: The objective of this analysis was to evaluate quantitative and qualitative outcomes at six months. Design: In this single-center, phase 2, parallel, 1:1:1 randomized trial conducted December 2016 to December 2018, English-speaking parents with a 2-24 year-old child diagnosed with new cancer were randomly assigned to UC, one-on-one, or group PRISM-P, a brief, skill-based curriculum targeting stress management, goal setting, cognitive reframing, and meaning making. We collected parent-reported outcomes (resilience, benefit finding, and psychological distress) at baseline and three and six months. We applied linear mixed-effects regression models to examine six-month outcomes among all participants and conducted directed content analyses of exit interviews with the first 12 parents to complete each study arm. Results: The 94 participating parents were median aged 35-38 years and predominantly white, college-educated mothers. At six months, there was no statistically significant difference in parent-reported outcomes. Exit interviews (n = 36) suggested that PRISM-P was highly valued: 100% of interviewed recipients recommended it for other parents. Most suggested more coaching would help them retain skills, and almost all endorsed a combined one-on-one and group program. Conclusions: Although the PRISM-P benefits observed at three months were not sustained for six months, all interviewed parents found it valuable. Additional opportunities to strengthen and sustain resilience resources include longer follow-up, flexible format, and skill reinforcement. Trial Registration: NCT02998086.

Dataset Information

Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care.

Objective

Methods

Results

Conclusions

Publications

Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care.

Similar Datasets

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