Responsivity to Problem-Solving Skills Training in Mothers of Children With Cancer.

OBJECTIVE: Bright IDEAS (BI) is a problem-solving skills training (PSST) program that has been demonstrated in earlier randomized controlled trials (RCTs) to be an effective and specific intervention for improving problem-solving skills and reducing negative affect in caregivers of children with cancer. The objectives of this study were to (a) offer an approach to defining meaningful treatment response and to determine the rates of responsivity to PSST; and (b) identify characteristics of PSST responders and nonresponders. METHODS: Data from 154 mothers receiving the BI intervention were analyzed. Drawing on the literature on minimal clinically important differences, two criteria for determining responsivity were calculated for the primary outcome of problem-solving skills: (a) The reliable change index (RCI) based on group data, and; (b) The effect size (ES) of each participant's pre/postintervention change score as a function of the group's baseline SD. RESULTS: Thirty-three percent of the sample met both responsivity criteria immediately posttreatment (39% at follow-up) and 38% (39% at follow-up) met neither. An additional 29% demonstrated a small or greater ES (≥ 0.2) but did not meet the RCI criteria, suggesting possible benefit. The single consistent predictor of responsivity was participants' pretreatment problem-solving skills, with lower skills at baseline predicting greater improvement (p < .001). CONCLUSIONS: These findings highlight the need to go beyond group data in interpreting RCTs and to incorporate measures of meaningful treatment response. Our ability to predict and screen for meaningful treatment response is critical to more precise targeting, enhanced outcomes, and better resource allocation.

In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial.

BACKGROUND: Bright IDEAS (BI) problem-solving skills training is an evidence-based intervention designed to help parents manage the demands of caring for a child with cancer. However, the resource intensiveness of this in-person intervention has limited its widespread delivery. We conducted a multicenter, randomized trial with a noninferiority design to evaluate whether a web-based version of BI requiring fewer resources is noninferior to in-person administration. METHODS: 621 caregivers of children with newly diagnosed cancer were randomly assigned to standard BI delivered face-to-face or a web-based version delivered via mobile device. The primary outcome was caregiver-reported problem-solving skills. The noninferiority margin was defined as 0.2 standard deviation units of the change from baseline to end of intervention. Secondary outcomes included caregiver-reported mood disturbance, depression, and posttraumatic stress symptoms. The study was registered with ClinicalTrials.gov Identifier: NCT01711944. FINDINGS: The effect of the standard treatment was preserved; parents in the standard BI arm improved their problem-solving (effect size = 0.53, t = 8.88, p < .001). Parents in the web-based BI group also improved their problem-solving (effect size = 0.32, t = 5.32, p < .001). Although the web-based intervention preserved 60% of the standard treatment effect, the test of noninferiority was non-significant (effect size = -0.21, p = 0.55). Similarly, the web-based intervention preserved > 60% of the standard intervention effect on all secondary outcomes; however, tests of noninferiority were non-significant. INTERPRETATION: Noninferiority of web-based BI relative to standard face-to-face administration was not established. Further development of the web-based BI is needed before it can be recommended as a stand-alone intervention. However, the documented benefits of the web-based intervention as well as the advantages of low resource utilization and ease of delivery suggest that further development of web-based BI is indicated, and that it may play a valuable role in alleviating distress in caregivers of children with serious or chronic illness. FUNDING: National Institutes of Health (U.S.), R01 CA159013 (P.I. Sahler).

Longitudinal Patterns of Social Problem-Solving Skills in an Ethnically Diverse Sample of Pediatric Patients with Cancer and their Caregivers.

Pediatric patients with acute lymphoblastic leukemia and lymphoblastic lymphoma are prescribed a daily oral chemotherapy medication named 6-mercaptopurine. Adherence to this medication is vital for survival and decreased risk for disease relapse. Adaptive problem-solving strategies are important for adhering to this complex regimen. This manuscript examined ethnic and racial differences in social problem-solving domains (Social Problem-Solving Inventory) among patients aged 7-19 years old who were diagnosed with cancer; and, their caregivers (N = 139). This was a 15-month longitudinal study. We also examined differences in medication adherence based on behavioral adherence measures. Our study found significant differences between minority and non-minority reporters across multiple social problem-solving domains (p < 0.05). However, there were no significant differences observed for medication adherence. Our findings underscore the importance of implementing culturally sensitive interventions in clinical care that could ultimately positively impact health behaviors, interactions with healthcare providers, and long-term health outcomes.

Measuring Medication Adherence in Pediatric Cancer: An Approach to Validation.

Objective: This study described the prospective relationship between pharmacological and behavioral measures of 6-mercaptopurine (6MP) medication adherence in a multisite cohort of pediatric patients diagnosed with cancer ( N = 139). Methods: Pharmacological measures (i.e., metabolite concentrations) assessed 6MP intake. Behavioral measures (e.g., electronic monitoring) described adherence patterns over time. Results: Three metabolite profiles were identified across 15 months: one group demonstrated low levels of both metabolites (40.8%) consistent with nonadherence and/or suboptimal therapy; two other groups demonstrated metabolite clusters indicative of adequate adherence (59.2%). Those patients whose metabolite profile demonstrated low levels of both metabolites had consistently lower behavioral adherence rates. Conclusions: To our knowledge, this was the first study to prospectively validate a pharmacological measure of medication adherence with a behavioral adherence measure in a relatively large sample of pediatric patients with cancer. Using multiple methods of adherence measurement could inform clinical care and target patients in need of intervention.

Electronic monitoring of medication adherence in early maintenance phase treatment for pediatric leukemia and lymphoma: identifying patterns of nonadherence.

OBJECTIVE: To describe patterns of treatment adherence to early maintenance phase therapy for acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). METHODS: Using an objective observational method (electronic monitoring), adherence was examined for 139 patients aged 7-19 years diagnosed with ALL or LBL across 6 centers. RESULTS: The mean adherence percentage was 86.2%. Adherence rates declined over the 1-month of follow-up to 83%. 3 linear trajectories of 6-mercaptopurine adherence were identified: (1) exemplary adherence (n = 99): Averaging nearly 100%; (2) deteriorating (n = 23): Adherence decreased from 100 to 60%; and (3) chronically poor adherence (n = 9): Averaging 40%. CONCLUSIONS: Adherence promotion interventions might be tailored to subgroups of patients who demonstrated problematic patterns of treatment adherence that could place them at risk for relapse. This research demonstrates the importance of using objective real-time measures of medication adherence for measuring and documenting adherence patterns.

Evaluation of the psychometric properties of the Pediatric Parenting Stress Inventory (PPSI).

OBJECTIVE: This work evaluated the psychometric properties of the Pediatric Parenting Stress Inventory (PPSI), a new measure of problems and distress experienced by parents of children with chronic illnesses. METHOD: This secondary data analysis used baseline data from 1 sample of English-, Spanish-, and Hebrew-speaking mothers of children recently diagnosed with cancer (n = 449) and 1 sample of English- and Spanish-speaking mothers of children recently diagnosed with cancer (n = 399) who participated in 2 problem-solving skills training interventions. The PPSI was administered at baseline with other measures of maternal distress. Factor structure was evaluated using exploratory factor analysis (EFA) on the first sample and confirmatory factor analysis (CFA) on both samples. Internal consistency was evaluated using Cronbach's alpha. Construct validity was assessed via Spearman correlations with measures of maternal distress. RESULTS: EFA resulted in a stable four-factor solution with 35 items. CFA indicated that the four-factor solution demonstrated reasonable fit in both samples. Internal consistency of the subscales and full scale was adequate to excellent. Construct validity was supported by moderate to strong correlations with measures of maternal distress, depression, and posttraumatic stress symptoms. CONCLUSIONS: The PPSI demonstrated good psychometric properties in assessing current problems and distress experienced by mothers of children newly diagnosed with cancer. This tool may be used to identify individualized targets for intervention in families of children with cancer. Future studies could evaluate the utility and psychometrics of the PPSI with other pediatric populations.

Intellectual functioning and multi-dimensional attentional processes in long-term survivors of a central nervous system related pediatric malignancy.

AIMS: Central nervous system (CNS) malignancies and/or their treatment in pediatric cancer survivors are known to be associated with deficits in neuropsychological functions. We report findings from a nation-wide study of childhood cancer survivors to investigate intelligence and attention/concentration from a multi-dimensional perspective in a diverse sample from this population. MAIN METHODS: Four hundred forty-four pediatric cancer survivors between 6 and 17 years of age, who had suffered CNS involvement associated with their malignancy, were evaluated. All patients completed a measure of general intelligence. Attention was measured by a continuous performance test (CPT) and by parental report using a standardized psychological inventory. KEY FINDINGS: Social economic status (SES) was a significant predictor of intellectual functioning and scores on independent measures of attention. After controlling for SES, cranial radiation therapy (CRT) was strongly predictive of impairments in intellectual functioning. Patients who had completed a transplant procedure did not have significant impairments in intellectual functioning when compared to other participants. CPT performance was most clearly influenced by a younger age at diagnosis and the presence of a supratentorial brain tumor. Reaction time was lower in patients who had received CRT. Gender did not correlate with CPT performance, but caregiver reports of deficits in attentional functioning were more prevalent in girls compared to boys. SIGNIFICANCE: These findings are important given the large, representative sample and multi-dimensional assessment of attentional functioning. The presence of a very strong SES effect on all dependent variables must be addressed in studies of this nature.

Benefit finding in fathers of childhood cancer survivors: a retrospective pilot study.

There is a growing literature examining positive outcomes following traumatic experiences. Although the diagnosis of a child with cancer poses extraordinary challenges for the family, awareness is growing that such a life-changing event can be a catalyst for positive growth. The current mixed methods study investigated benefit finding in fathers (N = 25) of childhood cancer survivors. Benefit finding included positive changes resulting from adversity. Participants completed a benefit finding measure and an interview describing their experience and benefits from the challenges faced during their child's cancer journey. Findings indicated that fathers endorsed high levels of benefit finding (mean = 4.1 out of 5) specifically in personal growth, spiritual change, and relationships with others. Our study extends the literature by examining how their child's cancer journey contributed to specific domains of paternal benefit finding. These results support the use of a positive psychology framework for understanding effects of a child's cancer diagnosis on caregivers.

Specificity of problem-solving skills training in mothers of children newly diagnosed with cancer: results of a multisite randomized clinical trial.

PURPOSE: Diagnosis of cancer in a child can be extremely stressful for parents. Bright IDEAS, a problem-solving skills training (PSST) intervention, has been shown to decrease negative affectivity (anxiety, depression, post-traumatic stress symptoms) in mothers of newly diagnosed patients. This study was designed to determine the specificity of PSST by examining its direct and indirect (eg, social support) effects compared with a nondirective support (NDS) intervention. PATIENTS AND METHODS: This randomized clinical trial included 309 English- or Spanish-speaking mothers of children diagnosed 2 to 16 weeks before recruitment. Participants completed assessments prerandomization (T1), immediately postintervention (T2), and at 3-month follow-up (T3). Both PSST and NDS consisted of eight weekly 1-hour individual sessions. Outcomes included measures of problem-solving skill and negative affectivity. RESULTS: There were no significant between-group differences at baseline (T1). Except for level of problem-solving skill, which was directly taught in the PSST arm, outcome measures improved equally in both groups immediately postintervention (T2). However, at the 3-month follow-up (T3), mothers in the PSST group continued to show significant improvements in mood, anxiety, and post-traumatic stress; mothers in the NDS group showed no further significant gains. CONCLUSION: PSST is an effective and specific intervention whose beneficial effects continue to grow after the intervention ends. In contrast, NDS is an effective intervention while it is being administered, but its benefits plateau when active support is removed. Therefore, teaching coping skills at diagnosis has the potential to facilitate family resilience over the entire course of treatment.

Quantifying the relationship among hospital design, satisfaction, and psychosocial functioning in a pediatric hematology-oncology inpatient unit.

BACKGROUND: Studies show that hospital built environments can affect physical and psychological outcomes and healthcare satisfaction in adults, but pediatric research is sparse. OBJECTIVE: To investigate the effects of the built environment on hospitalized pediatric hematology-oncology patients and their parents by testing the hypothesis that perceived built environment satisfaction mediates the relationship between the objective built environment and psychosocial functioning, as well as parental healthcare satisfaction. METHODS: The hospital built environment was evaluated subjectively through the PedsQL™ Hospital Healing Environment Module satisfaction questionnaires and objectively by quantifying environmental features. Outcomes for patients and parents included present functioning and affect. Healthcare satisfaction was also assessed for parents. Structural equation modeling (SEM) was used to test the mediational hypothesis. SUBJECTS: Participants were 90 hospitalized pediatric hematology-oncology patients and 149 parents of pediatric hematology-oncology patients. RESULTS: For both parents and children, analyses revealed a significant positive relationship between the quality of the objective built environment and built environment satisfaction. For parents, significant relationships emerged in the expected direction between built environment satisfaction and present functioning, healthcare satisfaction, and negative affect. CONCLUSIONS: Both pediatric hematology-oncology patients and their parents can reliably report their own perceived built environment satisfaction, which is significantly related to the quality of the objective built environment. For parents, results support the mediational hypothesis, highlighting the importance that perceived built environment satisfaction plays in psychosocial functioning and healthcare satisfaction.

Cognitive and problem solving training in children with cancer: a pilot project.

BACKGROUND: Neurocognitive sequelae are among the most debilitating late effects experienced by survivors of childhood cancer, with far reaching consequences for educational, social, and adaptive development. Empirically validated interventions to address such disease and treatment related psychosocial morbidities are needed. PROCEDURE: We conducted a pilot study to evaluate participants' acceptance and impact of a 15-session, clinic-based training program to teach compensatory learning and problem-solving skills in survivors with cognitive deficits. The intervention program consisted of 5 core components designed to improve daily problem solving, attention and memory, and academic performance. RESULTS: A sample of 12 survivors completed the program. Virtually all objective performance scores showed gains from preintervention to postintervention in the expected positive direction, although only 2 of the gains were statistically significant. Parent responses indicated they perceived the skills taught to be useful, to have improved the child's problem-solving ability and learning skills, to have provided concrete and practical interventions for the home, and to have increased parental knowledge. Similarly, the children rated the overall program high, and reported satisfaction with learning more about their relative cognitive strengths and weaknesses and practical problem solving for academic difficulties. CONCLUSIONS: Although the majority of enrolled families completed at least 70% of the training sessions, the overall low participation rate from eligible families raise concern about widespread acceptance of such programs in the oncology clinic. The limitations of the study design and recommendations for future research are discussed.

Qualitative analysis of the role of culture in coping themes of Latina and European American mothers of children with cancer.

It has been well established that mothers of children diagnosed with cancer experience high levels of distress. Latina mothers may be at risk for higher levels of distress related to language barriers, cultural factors, and economic, immigration, and acculturation stressors. Despite the increasing US Latino population, few studies have examined the role of culture within pediatric oncology, including how mothers cope with their child's cancer. This study used qualitative analysis of 24 sessions from 3 Latina and 3 European American mothers of children recently diagnosed with cancer. The session transcripts were divided into a total of 2328 thought segments that were then analyzed for themes using a collaborative iterative process. Analysis identified 9 shared coping themes that included, with some variations: gathering information, professional help-seeking, activities, problem solving, positive thinking, present orientation, reframing, avoidance, and religion. Three themes were culture specific: only European American mothers discussed compromise, whereas normalization and perspective taking were unique to the Latina mothers and suggest that the cultural value of simpatía influences coping. Clinical and research recommendations are discussed.

Problem solving and maternal distress at the time of a child's diagnosis of cancer in two-parent versus lone-parent households.

OBJECTIVE: To examine negative affectivity and problem-solving abilities for lone mothers and those who are married/partnered subsequent to a child's diagnosis with cancer. METHODS: Negative affectivity and problem-solving strategies were assessed for 464 mothers (87 lone and 377 married/partnered) within 2-16 weeks of their child's diagnosis with cancer. RESULTS: The two groups of mothers did not differ significantly on measures of perceived posttraumatic stress or problem-solving; lone mothers reported significantly more symptoms of depression. This difference was no longer significant when maternal education was taken into account. CONCLUSIONS: Negative affectivity and problem-solving abilities were similar for lone mothers and those that are married/partnered shortly after their child has been diagnosed with cancer. Findings are discussed within the context of contemporary strategies to assess marital status as proxy variable for various underlying constructs.

Report from a multi-institutional randomized clinical trial examining computer-assisted problem-solving skills training for English- and Spanish-speaking mothers of children with newly diagnosed cancer.

OBJECTIVES: To evaluate the feasibility and efficacy of a handheld personal digital assistant (PDA)-based supplement for maternal Problem-Solving Skills Training (PSST) and to explore Spanish-speaking mothers' experiences with it. METHODS: Mothers (n = 197) of children with newly diagnosed cancer were randomized to traditional PSST or PSST + PDA 8-week programs. Participants completed the Social Problem-Solving Inventory-Revised, Beck Depression Inventory-II, Profile of Mood States, and Impact of Event Scale-Revised pre-, post-treatment, and 3 months after completion of the intervention. Mothers also rated optimism, logic, and confidence in the intervention and technology. RESULTS: Both groups demonstrated significant positive change over time on all psychosocial measures. No between-group differences emerged. Despite technological "glitches," mothers expressed moderately high optimism, appreciation for logic, and confidence in both interventions and rated the PDA-based program favorably. Technology appealed to all Spanish-speaking mothers, with younger mothers showing greater proficiency. CONCLUSIONS: Well-designed, supported technology holds promise for enhancing psychological interventions.

Interventions to improve neuropsychological functioning in childhood cancer survivors.

A very brief historical review on the identification of neurocognitive deficits in patients treated for a pediatric malignancy that involved CNS disease, treatment, or a combination is provided. This review is particularly directed toward providing a foundation upon which the introduction of specific brain injury rehabilitation efforts and subsequent research were introduced into this population of patients. Three primary methods by which clinicians and researchers have attempted to improve neurocognitive functioning with survivors of pediatric cancer that have suffered a CNS insult are identified. From a pharmacological perspective, research is reviewed that documents the potential beneficial effects of stimulant medication. Results of two drug trials that used double-blind crossover methodology are reviewed, and it is highly likely that medications may be of significant benefit to pediatric cancer survivors who are experiencing attentional deficits, impairment in social functioning, and also declines in academic achievement. We next describe psychologically based brain injury rehabilitation efforts, including on-treatment schooling and reentry, within the survivor population. A phase III clinical trial of a comprehensive rehabilitation approach is discussed in detail. New directions in the area of brain injury rehabilitation for childhood cancer survivors are presented, and the need for professionals in this area to work toward a team approach is emphasized.

A multicenter, randomized clinical trial of a cognitive remediation program for childhood survivors of a pediatric malignancy.

Survivors of childhood cancer whose malignancy and/or treatment involved the central nervous system may demonstrate a consistent pattern of neurocognitive deficits. The present study evaluated a randomized clinical trial of the Cognitive Remediation Program (CRP). Participants were 6- to 17-year-old survivors of childhood cancer (N = 161; 35% female, 18% Hispanic, 10% African American, 64% Caucasian, 8% other) who were at least 1 year off treatment and who manifested an attentional deficit. They were enrolled at 7 sites nationwide. Two thirds of the participants were randomly assigned to cognitive remediation. All participants were assessed using a battery of academic achievement/neurocognitive tests and parent/teacher measures of attention. The CRP resulted in parent report of improved attention and statistically significant increases in academic achievement. Effect sizes were modest but were comparable with those for other clinical trials of brain injury rehabilitation and for psychological interventions in general. The CRP is presented as a potentially beneficial treatment for many survivors of pediatric cancer. Long-term clinical significance remains unproven. Further work is needed to improve effect sizes and treatment compliance and to address the needs of other populations with pediatric brain injury.

Trajectories of adjustment in mothers of children with newly diagnosed cancer: a natural history investigation.

OBJECTIVES: The objectives of this study were (a) to assess negative affectivity and posttraumatic symptomatology in mothers following the diagnosis of cancer in their children; (b) to examine sociodemographic and psychosocial variables associated with change in distress over time; and (c) to identify distinct subgroups of mothers whose patterns and trajectories of adjustment can be distinguished according to available predictor data. METHODS: Two hundred and twelve mothers at seven sites were assessed just following their child's diagnosis, and again 3 months and 6 months later. Primary outcomes included measures of mood disturbance, depressive symptoms, and symptoms of posttraumatic stress. RESULTS: Overall, mothers demonstrated a pattern of mildly elevated negative affectivity and posttraumatic symptomatology initially, with steady improvements evident at 3- and 6-month follow-up. Distinct adjustment trajectories were evident within the sample as a whole, indicating subgroups of mothers with high-declining, moderate-stable, and low-stable distress levels. CONCLUSIONS: These findings highlight considerable resilience among mothers facing the stress of childhood cancer. Intervention efforts aimed at reducing maternal distress might best be targeted towards the subgroup of mothers who may be predicted to exhibit the highest level of distress.

Attention dysfunction and parent reporting in children with brain tumors.

BACKGROUND: The IQ declines observed in children treated for brain tumor emerge as "late effects" and are conceptualized as secondary to changes in underlying mental processes, such as attention. Early identification of the underlying changes might help minimize the long-term adverse outcomes. We evaluated the validity of a time-efficient, standardized parent-report measure in identifying attention dysfunction in childhood brain tumor survivors. PROCEDURE: Seventy survivors between ages 6 and 16 who met eligibility criteria and who had completed a standard neuropsychological evaluation were classified into an attention dysfunction group and a non-attention dysfunction group, based on their performance on objective measures of attention. Analysis of covariance was used to evaluate group differences on the widely used, parent report Child Behavioral Checklist (CBCL). RESULTS: Survivors in the attention dysfunction group were reported by their parents as having significantly more attention problems relative to the group without attention dysfunction on objective testing. Furthermore, survivors categorized as having attention dysfunction based on their neuropsychological test scores were reported on the CBCL by their parents as having significantly more social problems compared to the non-attention dysfunction group. CONCLUSIONS: Standardized parent reporting of attention problems shows promise as a screening tool to detect attention dysfunction among survivors of childhood brain tumors. Findings include a strong association of decreased social functioning with attention dysfunction in brain tumor survivors. Furthermore, exploratory data suggest that the behavioral presentation of attention dysfunction in this group may be different from other clinical groups.

The PedsQL Brain Tumor Module: initial reliability and validity.

BACKGROUND: Brain tumors (BT) are second only to acute lymphoblastic leukemia as the most prevalent form of pediatric cancer, with BT 5-year survival rates approaching 70%. With increased survival, quality of life has emerged as an essential health outcome. This investigation examines the internal consistency reliability and construct validity of the Pediatric Quality of Life Inventory (PedsQL) Brain Tumor Module. METHODS: The PedsQL 4.0 Generic Core Scales, PedsQL Multidimensional Fatigue Scale, and PedsQL Brain Tumor Module were administered to 99 families. The average age of the 56 boys and 43 girls was 9.76 years (range=2-18 years). The sample included children with tumors located in the posterior fossa/brainstem (N=62, 62.6%), supratentorial (N=15, 15.2%), and midline (N=22, 22.2%). Children were on treatment (N=46, 46.5%), off treatment<12 months (N=19, 19.2%), or off treatment>12 months/long-term survivor (N=34, 34.3%). Treatment included radiation (N=61, 61.6%), surgery (N=83, 83.8%), chemotherapy (N=87, 87.9%), and bone marrow transplant (N=5, 5.1%). RESULTS: Internal consistency reliability was demonstrated for the 24-item PedsQL Brain Tumor Module (average alpha=0.78-0.92, parent proxy-report, n=99; average alpha=0.76-0.87, child self-report, n=51). Construct validity for the PedsQL Brain Tumor Module was supported through an analysis of the intercorrelations with the Generic Core Scales and Fatigue Scale. CONCLUSIONS: The findings provide support for the measurement properties of the PedsQL Brain Tumor Module.