Stop and Think: A Case Study Illustrating the Implementation of Bright IDEAS-YA Being Delivered via Telehealth to a Young Adult Cancer Patient.

Bright IDEAS-Young Adults (Bright IDEAS-YA) is a problem-solving skills training intervention that has been adapted for young adults with cancer. Presently, a multisite randomized control trial is being conducted to determine Bright IDEAS-YA's efficacy in supporting a young adult population. This case study demonstrates the young adult adaptation of Bright IDEAS - Bright IDEAS-YA - being delivered to a young adult cancer patient via telehealth. Telehealth is a novel delivery method for Bright IDEAS and Bright IDEAS-YA that was established due to COVID-19 safety precautions. The patient, who reported challenges in several life domains, was taught how to apply the Bright IDEAS-YA framework over six telehealth sessions. After completing the Bright IDEAS-YA framework, the patient reported increased feelings of confidence in managing new stressors, which was corroborated through outcome measures delivered during and following intervention. This case illustrates how early psychosocial intervention following a cancer diagnosis, delivered via telehealth, can help patients develop and implement personal strategies to reduce stress levels.

Understanding social network support, composition, and structure among cancer caregivers.

OBJECTIVE: We examined the social network support, composition, and structure of pediatric cancer caregivers. METHODS: We used a self-report survey to collect egocentric social network data from 107 caregivers of pediatric cancer patients and calculated descriptive statistics to examine cancer-related support network composition, function, and structure. We then ran logistic regressions to examine the relationships between network characteristics and overall satisfaction with social support. RESULTS: Family members were the most common source of emotional support and logistical support, and health care providers were the most common source of informational support. Participants perceived the "most helpful" forms of support as being: (1) emotional support from family and health care providers; (2) informational support from health care providers and other cancer caregivers; and (3) logistical support from family. Overall, caregivers wished that 9.8% of their network ties had provided more support, with family members being the most common alter type to disappoint caregivers and offer less support than needed/expected. Caregivers who reported higher network disappointment (having network members who offered less support than needed/expected) were significantly less satisfied with emotional support than those with lower network disappointment (Odds Ratio = 0.18, p = 0.02), and caregivers with higher network disappointment were significantly less satisfied with logistical support compared to those with lower network disappointment (Odds Ratio = 0.14, p = 0.01). CONCLUSION: Our results show differences in the nature of social support provided by different types of network members. These findings have implications for tailoring social network interventions to improve caregiver and family outcomes.

Dissemination of an evidence-based behavioral intervention to alleviate distress in caregivers of children recently diagnosed with cancer: Bright IDEAS.

BACKGROUND: Four multisite randomized clinical trials of > 1400 caregivers of children newly diagnosed with cancer showed that the Bright IDEAS (BI) paradigm of problem-solving skills training is an acceptable and efficacious approach to alleviating the high levels of distress they experience. To facilitate providing evidence-based caregiver support as recommended in the pediatric oncology standards of care, the project described here was designed to disseminate BI to 200 psychosocial professionals. PROCEDURE: We partnered with the Children's Oncology Group (COG), Association of Pediatric Oncology Social Workers (APOSW), Association of Pediatric Hematology/Oncology Nurses (APHON), and special interest group in pediatric hematology/oncology of the Society for Pediatric Psychology (SPP). Membership surveys revealed substantial enthusiasm for training in BI. We structured training to include review of the evidence base for BI, role plays, and strategies for implementation at individual sites. Four conference calls designed to enhance implementation were held one, two, three, and five months after training. RESULTS: Ten 1.5-day workshops were held in conjunction with annual meetings of COG, APOSW, APHON, and SPP. A total of 209 psychosocial clinicians from 134 sites were trained. Evaluations were highly favorable. Trainees had provided BI to 545 individuals as of the last conference call. CONCLUSIONS: Initial dissemination goals were met. BI is now available at numerous pediatric oncology centers, but it has not become part of routine care. Future work focused on implementation might consider top-down approaches that include direct communication with pediatric oncologists and hospital leaders about the benefits of incorporating this evidence-based intervention systemically.

An initial investigation of using smartphone-enabled micro-temporal data collection to increase acceptability, feasibility, and validity of research on cancer caregiving.

PURPOSE: Smartphone-enabled micro-temporal data collection has potential to increase reliability, validity, and feasibility of participant-reported data and is a promising strategy for pediatric oncology supportive care and quality-of-life research. Given the demands of pediatric cancer caregiving, we sought to understand the feasibility and acceptability of smartphone data collection that included short surveys administered daily for 14 days via text message link. METHODS: We recruited pediatric cancer caregivers, whose children (ages 0-18 years) were on active treatment, to complete a 14-day daily survey study via smartphone. We implemented our study procedures and examined feasibility through study enrollment rates, reasons for refusal, retention rates, number of reminders and number of completed surveys. We examined acceptability using caregiver ratings of survey length, burden, and ease of completion on a smartphone. RESULTS: We recruited (N = 75) caregivers to the study and had an 84% enrollment rate. Reasons for declining participation included passive refusal (n = 13) and too busy (n = 1). The participant retention rate was 100% and compliance with daily survey completion was 99%. Most surveys were completed following two prompts and took participants 5 minutes or less to complete. Caregivers rated the surveys as easy to complete, low burden, and just right in length. CONCLUSION: A daily self-report, using a brief (≤5 minutes) survey administered on a smartphone via text message prompt, is a feasible and acceptable method. Future research should extend these findings to understand the generalizability across pediatric cancer caregiving contexts.

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.

Feasibility of FitSurvivor: A technology-enhanced group-based fitness intervention for adolescent and young adult survivors of childhood cancer.

BACKGROUND: This study evaluated the feasibility of a technology-enhanced group-based fitness intervention for adolescent and young adult (AYA) survivors of childhood cancer. PROCEDURE: AYA survivors ages 13-25 years were randomized to the intervention (eight in-person group sessions with mobile app and FitBit followed by 4 weeks of app and FitBit only) or waitlist control. Assessments were at 0, 2, 3, 6, and 9 months. Feasibility was evaluated by enrollment, retention, attendance, app engagement, and satisfaction. Secondary outcomes included physical activity, muscular strength/endurance, cardiorespiratory fitness, health-related quality of life, and fatigue. RESULTS: A total of 354 survivors were mailed participation letters; 68 (19%) were screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible). Forty-nine survivors (Mage  = 18.5 years, 49% female) completed baseline assessments and were randomized (25 intervention, 24 waitlist). Thirty-seven (76%) completed the postintervention assessment and 32 (65%) completed the final assessment. On average, participants attended 5.7 of eight sessions (range 1-8). Overall intervention satisfaction was high (M = 4.3, SD = 0.58 on 1-5 scale). Satisfaction with the companion app was moderately high (M = 3.4, SD = 0.97). The intervention group demonstrated significantly greater improvement in lower body muscle strength compared to the waitlist postintervention, and small but not statistically significant changes in other secondary measures. CONCLUSIONS: A group-based intervention with a mobile app and fitness tracker was acceptable but has limited reach due to geographical barriers and competing demands experienced by AYA survivors.

Risk factors for chemotherapy-induced nausea in pediatric patients receiving highly emetogenic chemotherapy.

BACKGROUND: Little is known regarding risk factors for chemotherapy-induced nausea (CIN) in pediatric patients. PROCEDURE: A secondary analysis was conducted of a previously published multicenter, prospective, randomized, single-blind, sham-controlled trial assessing the efficacy of acupressure in preventing CIN in pediatric patients receiving highly emetogenic chemotherapy. The primary outcome was nausea severity, self-reported using the Pediatric Nausea Assessment Tool. The relationships between acute and delayed nausea severity and patient- (sex, race, age, and cancer diagnosis) and treatment-related (chemotherapy, antiemetic prophylaxis, CIN, and vomiting control) factors were analyzed by a proportional odds generalized estimating equation approach. The acute phase started with administration of the first and continued for 24 hours after the last chemotherapy dose. The delayed phase started at the end of the acute phase and continued until the next chemotherapy block (maximum seven days). RESULTS: In the acute and delayed phases, 165 and 144 patients provided data for analysis, respectively. Nonwhite race was significantly associated with higher acute phase nausea severity (OR, 1.7; 95% CI, 1.1-2.6). Poor CIN control in the acute phase (OR, 16; 95% CI, 4.0-64.6), diagnosis of a cancer other than a central nervous system (CNS) tumor (OR, 2.5; 95% CI, 1.2-5.3), and cisplatin administration (OR, 3.7; 95% CI, 2.1-6.0) were significantly associated with higher delayed phase nausea severity. CONCLUSION: Acute phase CIN was associated with nonwhite race. Delayed phase CIN was associated with poor acute phase CIN control, diagnosis of non-CNS cancer, and receipt of cisplatin. These findings will inform future antiemetic trial design.

Acupressure bands do not improve chemotherapy-induced nausea control in pediatric patients receiving highly emetogenic chemotherapy: A single-blinded, randomized controlled trial.

BACKGROUND: Chemotherapy-induced nausea and vomiting remain common, distressing side effects of chemotherapy. It has been reported that acupressure prevents chemotherapy-induced nausea in adults, but it has not been well studied in children. METHODS: In this multicenter, prospective, randomized, single-blind, sham-controlled trial, the authors compared acute-phase nausea severity in patients ages 4 to 18 years who were receiving highly emetic chemotherapy using standard antiemetic agents combined with acupressure wrist bands, the most common type of acupressure, versus sham bands. Patients wore acupressure or sham bands continuously on each day of chemotherapy and for up to 7 days afterward. Chemotherapy-induced nausea severity in the delayed phase and chemotherapy-induced vomiting control in the acute and delayed phases also were compared. RESULTS: Of the 187 patients randomized, 165 contributed nausea severity assessments during the acute phase. Acupressure bands did not reduce the severity of chemotherapy-induced nausea in the acute phase (odds ratio [OR], 1.33; 95% confidence limits, 0.89-2.00, in which an OR <1.00 favored acupressure) or in the delayed phase (OR, 1.23; 95% CL, 0.75-2.01). Furthermore, acupressure bands did not improve daily vomiting control during the acute phase (OR, 1.57; 95% CL, 0.95-2.59) or the delayed phase (OR, 0.84; 95% CL, 0.45-1.58). No serious adverse events were reported. CONCLUSIONS: Acupressure bands were safe but did not improve chemotherapy-induced nausea or vomiting in pediatric patients who were receiving highly emetic chemotherapy. Cancer 2018;124:1188-96. © 2017 American Cancer Society.

Problem-solving skills, parent-adolescent communication, dyadic functioning, and distress among adolescents with cancer.

Some adolescents with cancer report distress and unmet needs. Guided by the disability-stress-coping model, we evaluated associations among problem-solving skills, parent-adolescent cancer-related communication, parent-adolescent dyadic functioning, and distress in adolescents with cancer. Thirty-nine adolescent-parent dyads completed measures of these constructs. Adolescents were 14-20 years old on treatment or within 1 year of completing treatment. Better problem-solving skills were correlated with lower adolescent distress (r = -0.70, P < 0.001). Adolescent-reported cancer-related communication problems and dyadic functioning were not significantly related to adolescent distress (rs < 0.18). Future work should examine use of problem-solving interventions to decrease distress for adolescents with cancer.

Factors Associated With Noncompliance With Long-term Follow-up Care Among Pediatric Cancer Survivors.

Most childhood cancer survivors do not receive risk-based care through a survivorship program, but factors associated with dropping out of care are unclear. This study aimed to identify characteristics of pediatric cancer survivors who do not return to a cancer center survivorship program for recommended care after at least 1 visit compared with those who continue to attend. Patient characteristics (demographics, school functioning, psychiatric history) and treatment characteristics (diagnosis, treatment) were abstracted from medical records for all eligible patients. Unadjusted and multivariable logistic regression analyses examined the associations among patient and treatment characteristics and nonattendance. The charts of 400 eligible patients (children below 18, n=123; adults, n=277) were reviewed. Of these, 60.3% of patients had not been seen in clinic within 1 year of their last recommended follow-up appointment. Adult-aged survivors were less likely to return to clinic than child-aged survivors (P<0.001). For child survivors, longer time off treatment was associated with noncompliance with follow-up. For adult survivors, current age, nonwhite race, and longer time off treatment were associated with noncompliance. Additional methods to identify survivors at risk for noncompliance with follow-up and interventions for at-risk survivors are needed to improve survivorship care.

Psychometric properties of the 52-, 25-, and 10-item English and Spanish versions of the Social Problem-Solving Inventory-Revised.

Objective: The Social Problem-Solving Inventory-Revised (SPSI-R) is a widely used instrument to assess problem-solving ability. This study examined the factor structure of the 52-, 25-, and 10-item versions of the SPSI-R and assessed factorial invariance across English- and Spanish-speaking participants. In addition, the internal consistency, test-retest reliability and sensitivity to detect change in problem-solving skills over time were assessed across the three different versions of the SPSI-R. Methods: Data from three randomized controlled trials, in which caregivers of children with cancer (N = 1,069) were assigned to either a problem-solving skills intervention (N = 728) or a control condition (N = 341), were combined. The SPSI-R was administered at baseline (T1) and immediately post intervention (T2). Reliability and multigroup analyses were performed with confirmatory factor analysis (CFA). Sensitivity to change analyses were performed using repeated measures ANOVA. Results: Confirmatory factor analysis at T1 showed good fit statistics and internal consistency for the 52- and the 25-item versions, but not for the 10-item version. Factorial invariance was demonstrated across time (T1-T2) and language (Spanish-English) for both the 52- and 25-item versions. Adequate sensitivity to change over time was shown. Conclusion: The 52- and 25-item versions of the SPSI-R appear reliable and valid for assessment of problem-solving skills in English- and Spanish-speaking caregivers of children with newly diagnosed cancer. The 25-item SPSI-R can be used as a short version measuring problem-solving ability; the 10-item version cannot be considered a reliable measure for this population.

Pediatric oncologists' practices of prescribing selective serotonin reuptake inhibitors (SSRIs) for children and adolescents with cancer: a multi-site study.

OBJECTIVE: To survey pediatric oncologists regarding prescription of selective serotonin reuptake inhibitors (SSRIs) and related medications for the treatment of depression and anxiety disorders in children with cancer. Specifically, we sought to determine (a) how frequently pediatric oncologists prescribed SSRIs and what were the most commonly prescribed agents; (b) how decisions were made to prescribe, particularly whether mental health professionals were consulted; (c) how patients were monitored while on the agents; and (d) how the FDA black box warning has affected prescribing practices. METHOD: Oncologists from nine children's cancer centers (N = 151) from across the U.S. were surveyed, responding to either on-line or paper versions of a questionnaire developed for this study. RESULTS: A majority of oncologists (71%) reported prescribing SSRIs for their patients. Oncologists reported difficulties differentiating symptoms of depression from aspects of cancer treatment. Mental health practitioners are consulted occasionally but not routinely, and oncologists reported a need for increased mental health resources. Approximately half of oncologists (51%) reported that the FDA black box warning had not affected their practice. In addition, only 28% reported monitoring patients on SSRIs at FDA recommended intervals, and only 9% indicated assessing for suicidality. CONCLUSIONS: Prescription of SSRIs is a common practice of pediatric oncologists, often without consultation with mental health professionals. Post-prescription monitoring appears to be suboptimal, and does not follow FDA guidelines.

Core functions and forms of Bright IDEAS: A multi-methods evaluation of the adoption of an evidence-based psychosocial training program through iterative adaptation.

Background: Despite efforts to widely disseminate interventions designed to increase access to quality supportive care to pediatric cancer patients and their families, many of these interventions fail to meet expectations once deployed in real-life clinical settings. This study identifies the functions and forms of Bright IDEAS: Problem-Solving Skills Training, an evidence based psychosocial intervention for caregivers of children recently diagnosed with cancer, to identify pragmatic program adaptations in its real-world clinical implementation. We compare intervention adoption before and after adaptations to the Bright IDEAS training program as part of a national training program designed to disseminate the intervention. Methods: 209 pediatric psychosocial oncology practitioners representing 134 unique institutions were trained during 10 in-person 8-hour workshops (2015-2019). Functions and forms of Bright IDEAS were identified, and adaptations made to the training agenda and curriculum based on practitioner feedback following implementation in local institutions. Mixed method evaluation included longitudinal surveys at 6- and 12-months post training; and qualitative interviews among a subgroup of practitioners (N = 47) to understand and compare perspectives on intervention adoption and barriers to implementation before and after adaptations to the Bright IDEAS training program. The RE-AIM framework was used to guide dissemination evaluation. Results: A total of four adaptations were tailored to the identified forms of the intervention: case studies; pre-training reading materials; training videos; and letters of institutional support from primary supervisor. Pre- and post-training adaptations to the Bright IDEAS training program were mapped to RE-AIM constructs. Quantitative findings demonstrate that adaptations appeared to improve adoption and usage overall. Conclusion: This study provides insight into how contextual factors influence psychosocial practitioners' capacity to adopt, implement, and maintain Bright IDEAS in the clinical setting. This study demonstrates the use of real-time stakeholder feedback to guide intervention translation from research to practice settings.

Feasibility and Acceptability of Bright IDEAS-Young Adults: A Problem-Solving Skills Training Intervention.

BACKGROUND: Young adults with cancer are a vulnerable group with unique emotional, social, and practical needs. There is a lack of evidence-based interventions to address their needs and to foster skills that could increase their capacity to cope. Bright IDEAS is a problem-solving skills training intervention that has demonstrated efficacy in improving people's problem-solving ability and reducing distress among caregivers of children with cancer. This study evaluated the feasibility and acceptability of Bright IDEAS adapted for young adults (Bright IDEAS-YA). METHODS: Forty young adults recently diagnosed with cancer were enrolled in a single arm feasibility study. RESULTS: Feasibility was demonstrated by the adequate enrollment (67.8%), retention (80.0%), and participants' adherence to the intervention (average of 5.2 out of 6 sessions completed). Participants reported satisfaction with the intervention. Qualitative feedback identified the systematic approach to problem-solving and interaction with the trainer as strengths of the intervention. Participants demonstrated improvements in problem-solving skills and symptoms of depression and anxiety. CONCLUSIONS: In conclusion, the results support the feasibility of the intervention and an adequately powered randomized controlled trial is needed to determine the efficacy of the intervention on psychosocial outcomes.

Factors Associated with COVID­19 Vaccine Uptake Among Adolescents and Young Adults Recently Diagnosed with Cancer.

Adolescents and young adults (AYAs) recently diagnosed with cancer are medically vulnerable but little is known about vaccine uptake/intent in this group. AYAs reported on their COVID-19 vaccine uptake/intent. Logistic regression models examined factors associated with vaccine uptake. Higher education (adjusted odds ratio [aOR] = 1.9, 95% confidence interval [CI]: 1.0-3.5) and knowing someone diagnosed with COVID-19 (aOR = 7.2, 95% CI: 1.6-33.5) were associated with increased vaccine uptake. Prior personal diagnosis of COVID-19 (aOR = 0.1, 95% CI: 0.1-0.7) was associated with lower odds of uptake. Targeted interventions may be needed to improve uptake among this group. (ClinicalTrials.gov Identifier: NCT04585269).

Problem-solving skills training in adult cancer survivors: Bright IDEAS-AC pilot study.

PURPOSE: Cancer patients experience significant distress and burden of decision-making throughout treatment and beyond. These stressors can interfere with their ability to make reasoned and timely decisions about their care and lead to low physical and social functioning and poor survival. This pilot study examined the impact of offering Problem-Solving Skills Training (PSST) to adult cancer survivors to help them and their caregivers cope more successfully with post-treatment decision-making burden and distress. PATIENTS AND METHODS: Fifty patients who completed their definitive treatment for colorectal, breast or prostate cancer within the last 6 months and reported distress (level > 2 on the National Comprehensive Cancer Network distress thermometer) were randomly assigned to either care as usual (CAU) or 8 weekly PSST sessions. Patients were invited to include a supportive other (n = 17). Patient and caregiver assessments at baseline (T1), end of intervention or 3 months (T2), and at 6 months (T3) focused on problem-solving skills, anxiety/depression, quality of life and healthcare utilization. We compared outcomes by study arm and interviewed participants about PSST burden and skill maintenance. RESULTS: Trial participation rate was 60%; 76% of the participants successfully completed PSST training. PSST patients reported reduction in anxiety/depression, improvement in QoL (p < 0.05) and lower use of hospital and emergency department services compared to CAU patients (p = 0.04). CONCLUSIONS: The evidence from this pilot study indicates that a remotely delivered PSST is a feasible and potentially effective strategy to improve mood and self-management in cancer survivors in community oncology settings.

Children's appraisals of threat in pediatric cancer☆.

PURPOSE: Although many children with cancer cope well with challenges, some experience distress that results in poor adjustment. Children's perceptions of threat may be one explanation for heterogeneity in outcomes, but relatively little is known about what children find threatening. This study aimed to describe the threats that children report. METHOD: Youth (4-18 years old) newly diagnosed with cancer and their primary/parent caregivers (PC) participated in a multi-method study. Appraisals of threat were assessed via self-report and a narrative technique at two weeks post-diagnosis. PCs reported children's anxiety and depressive symptoms three months post-diagnosis and children reported their quality of life (QOL) six months post-diagnosis. RESULTS: Youth reported various types of threatening events (e.g., receiving the cancer diagnosis, fear or pain of procedures) across multiple domains (e.g., threat to self, physical threat, threat of loss). Adolescents tended to report threat to life (e.g., the seriousness of the diagnosis itself) whereas younger children reported other threats (e.g., procedural pain). Children with high perceived threat to self had higher subsequent anxiety symptoms and lower QOL compared to those with low appraisals of threat to self. There was also a significant mean difference between high and low appraisals of threat of loss in child reported QOL. CONCLUSIONS: Youths' reported threats, as well as how threat appraisals related to adjustment outcomes in distinct ways, underscores the developmental nature of how youth interpret medically stressful events and the utility of developmentally sensitive assessment. Understanding perceived threat could ultimately inform efforts to foster positive long-term adaptation for youth with cancer.

Music therapy as an adjunctive treatment in the management of stress for patients being weaned from mechanical ventilation.

This project investigated music therapy (MT) in managing anxiety associated with weaning from mechanical ventilation. The use of sedation to treat anxiety during weaning is problematic because side effects (e.g., respiratory depression) are precisely the symptoms that cause the weaning process to be interrupted and consequently prolonged. Study goals were to determine the feasibility of incorporating MT into the weaning process and to evaluate the efficacy of the intervention, based on levels of anxiety, Days to Wean (DTW), and patient/nurse satisfaction. Adult patients received multiple MT sessions per week while undergoing weaning trials from mechanical ventilation. Feasibility was determined by successful enrollment in the study and nurse survey. Efficacy was evaluated through anxiety, as measured by heart rate, respiratory rate, and patient/nurse survey; DTW; and patient/nurse satisfaction. Nurse surveys reported that MT was successfully incorporated into the milieu and 61 subjects were enrolled. Significant differences in heart rate and respiratory rate were found from the beginning to the end of MT sessions (p < .05 and p < .0001, respectively), indicating a more relaxed state. No significant difference in mean DTW was found between study and control subjects. Patient/nurse satisfaction was high. Music therapy can be used successfully to treat anxiety associated with weaning from mechanical ventilation. Limitations and suggestions for further research are discussed.

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).

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.