Background and Aims

Children with cancer suffer from numerous symptoms and side-effects, making supportive interventions indispensable to improve their health-related quality of life (HRQOL). The gold standard for evaluating HRQOL are patient-reported outcome measures (PROMs). This systematic review investigated the current practice of clinical outcome assessment (COA) in clinical trials on supportive interventions.

Methods

ClinicalTrials.gov and EudraCT were searched for clinical trials investigating supportive interventions in children and adolescents (≤21 years) with cancer, which have been registered between 2007 and 2020. The use of different types of COAs (i.e., PROMs, performance-based, clinician-, or observer-reported outcomes) was analysed, focusing on PROMs. Associations with trial characteristics were investigated using univariate and multivariable analyses.

Results

Of 4789 identified clinical trials, 229 were included. Among them, 44.1% relied on PROMs, which were the most commonly used COA. The proportion of trials using PROMs did not significantly differ over time. In the multivariable analysis, intervention type (higher PROM use in behavioural vs. medical interventional trials) and cancer type (higher PROM use in mixed and solid tumour samples vs. haematological samples) were significant predictors of PROM use. The majority of trials using PROMs (59.6%) measured more than one health domain. Physical health was the most frequently assessed domain (92.6%).

Conclusions

Less than half of registered trials investigating supportive interventions for children with cancer used PROMs. While this proportion is higher than in clinical trials evaluating anti-cancer treatments for paediatrics, it is inferior to that in adult oncology research. Overall, the result is striking since supportive care explicitly aims to improve patients’ HRQOL, which is best assessed using PROMs. PROM assessment in clinical trials evaluating supportive interventions should therefore be the norm rather than the exception. Our systematic review underlines the need to identify and overcome barriers for PROM implementation and to improve PROM research in paediatric oncology.

Background and Aims

Psychosocial screening for oncology patients is considered standard of care, yet most pediatric institutions have not implemented evidence-based screening programs. Guided by the RE-AIM framework, this study evaluated the reach, implementation, and effectiveness of an electronic psychosocial screening program among outpatient pediatric oncology patients.

Methods

Participants (N=2,367) included patients aged 2.0-21.9 years (M=10.9, SD=5.4) presenting across 10,062 outpatient oncology visits from September 2018 to June 2019. At clinic visit check-ins, patients (≥13 years) or caregiver proxies (patients <13 years) electronically completed the Distress Thermometer (DT), providing numerical ratings of distress (0-10) via a patient-facing electronic medical record (EMR) application (i.e., Epic Welcome). EMR data were abstracted to characterize the reach and implementation of the e-screening program. Factors associated with high distress scores were evaluated using univariate logistic regression.

Results

The e-screening program reached nearly all patients seen during the study period (96.7%; 2,290/2,376). Overall, 7.8% (179/2,290) of patients ever indicated high distress (DT score ≥8), while 26.6% (608/2,290) and 65.6% (1,503/2,290) reported moderate (DT score 5-7) and low (DT score 0-4) levels of distress, respectively. Patients with high distress scores were more likely to be female (Odds Ratio [OR]=1.50, 95% Confidence Interval [CI]: 1.11-2.04), newly diagnosed (OR=2.07, 95% CI: 1.33-3.21), and older at time of diagnosis (Reference: 0-5 years; 10-14 yrs: OR=2.97, 95% CI: 1.99-4.45; 15-21 yrs: OR=3.42, 95% CI: 2.21-5.29). Regarding implementation fidelity, medical staff followed screening protocols referring 93.9% (222/231) of high distress encounters to psychology. Of the 78.8% (175/222) of families who did not decline psychology services, psychology consults were provided to 76.0% (133/175) of those in high distress at point-of-care.

Conclusions

Leveraging EMR technology to provide evidence-based psychosocial screening can successfully reach pediatric oncology patients, effectively link patients to timely mental health supports, and be easily scaled to other pediatric cancer centers.

Background and Aims

Over the past years, a wide range of digital health interventions for pain in children with cancer have been developed. We aimed to provide an overview of existing interventions and assess the state of the field. Second, we evaluated aspects slowing down (barriers) or facilitating (facilitators) eventual/potential implementation.

Methods

A comprehensive literature search (PubMed, Cochrane, Embase, and PsycINFO) was carried out to identify peer-reviewed articles which included the use of digital health interventions for pain in children (0-18), or their parents, with cancer (all diagnoses) during active treatment. Corresponding authors of the interventions were invited for a semi-structured interview on barriers and facilitators.

Results

Of 109 potential records examined, 21 met inclusion criteria, describing 13 separate digital health interventions monitoring pain in pediatric oncology. Several platforms were used for delivery: apps (n=11), a web-portal (n=1) and a wristband (n=1). Functionalities consisted of: pain severity monitoring (n=12), providing information about pain(treatment) (n=5) and communication options with healthcare professionals or peers (n=8). Most publications focused on feasibility/usability/acceptability testing (n=9). Currently there are no publications on effectiveness, yet several (n=4) Randomized Controlled Trials are being carried out. 12/13 project leaders agreed to be interviewed. Their working experience within the digital health field averaged 12 years. Most barriers related to the organization (i.e. financial/time resources) and socio-political context (i.e. juridical regulations). Most facilitators related to the intervention itself (i.e. user friendliness) and end-users (i.e. buy-in from patients/parents/nurses). 3/12 project leaders reported using a theoretical model for implementation (i.e. Consolidated Framework for Implementation Research [CFIR], Knowledge-to-Action [KTA] Framework, and Reach, Effectiveness, Adoption, Implementation, and Maintenance [RE-AIM]).

Conclusions

Thirteen interventions were identified and these were mostly apps directed at pain severity monitoring. Yet, little is known so far about their effectiveness. Paying attention to common barriers and facilitators at the early stages of new projects might improve future implementation.

Background and Aims

Pain is common among adult survivors of childhood cancer. Multimodal intervention is the gold-standard treatment for pain. However, little is known about survivors’ use of pharmacologic and nonpharmacologic interventions, including integrative medicine (IM), and self-medication.

Methods

Adult survivors in the SJLIFE cohort were evaluated for self-reported pharmacologic and nonpharmacologic intervention use. Modified Poisson regression estimated relative risks (RR) and 95% confidence intervals (CI) for associations between pain and pharmacologic and nonpharmacologic intervention use, IM, and self-medication. Latent class analysis was conducted to identify patterns of intervention use.

Results

3,390 survivors (50.4% male; mean [SD] age 30.7[8.4] years; 22 [8.4] years since diagnosis) self-reported pharmacologic (e.g., opioids) and nonpharmacologic intervention use (e.g., physical therapy), IM (e.g., acupuncture), self-medication (e.g., illicit drug use), pain intensity and pain interference, and psychosocial symptoms (anxiety, depression, sleep, fatigue). Overall, 20% reported moderate to very severe pain and 16% reported moderate to very severe pain with moderate to extreme daily interference. In models adjusted for age, sex, race/ethnicity and psychosocial symptoms, pain with and without interference was associated with increased risk of any pharmacologic intervention (RR [95% CI]; 1.75 [1.45-2.10] and 2.55 [2.11-3.07], respectively) and self-medication (1.10 [1.01-1.20] and 1.13 [1.03-1.25], respectively), but not nonpharmacologic interventions or IM use. Three patterns of intervention use were identified: 1) elevated nonpharmacologic + IM (43%), 2) elevated self-medication (17%), and 3) elevated nonpharmacologic + IM + self-medication (40%). All classes had similar rates of pharmacologic intervention use. Pain with interference increased risk of self-medication and nonpharmacologic + IM + self-medication compared to nonpharmacologic + IM use.

Conclusions

Adult survivors experiencing pain are more likely to use pharmacologic interventions and engage in behaviors reflecting self-medication, suggesting inadequate pain management. Routine assessment of pain interventions used by survivors, including both adaptive and maladaptive strategies, is needed.

Background and Aims

Late effects of treatment and their impact on health-related quality of life (HRQOL) has become a key goal of childhood cancer survivorship care. One of the most prevalent late effects is cancer-related fatigue (CRF). Since the impact of CRF on HRQOL is poorly understood, the current study aimed to investigate the association between CRF and HRQOL in a nationwide cohort childhood cancer survivors (CCS).

Methods

Participants were included from the Dutch Childhood Cancer Survivor Study (DCCSS) LATER cohort, a nationwide cohort of five-year CCS. Participants completed the Checklist Individual Strength (CIS) to indicate CRF (CIS-fatigue ≥35 and duration of symptoms ≥6 months) and the Short Form-36 (SF-36) and TNO and AZL QOL questionnaire (TAAQOL) as measures for HRQOL. Independent t-tests were calculated to identify differences in mean HRQOL domain scores between CRF and non-CRF participants. The association between CRF and impaired HRQOL (scoring 2 SD below population norm) was tested using multivariable logistic regression to adjust for potential confounders.

Results

A total of 1,695 CCS participated in the study (23.1% with CRF). Mean total scores of all HRQOL domains were significantly lower for the CRF group compared to the non-CRF group, with mean differences ranging from 14.0 (95%CI 11.4 – 16.7) on sexuality to 41.6 (95%CI 38.2 – 45.0) on physical work limitations. CRF was associated with an impaired HRQOL on all studied domains with adjusted odds ratio’s ranging from 1.6 (95%CI 1.1-2.4) for the sexuality domain to 30.4 (95%CI 16.4 – 56.2) for the vitality domain.

Conclusions

Understanding the impact of late effects on HRQOL is crucial when aiming to improve the quality of CCS daily lives. The current study shows CRF to have a negative impact on multiple HRQOL domains, indicating the urge of structural screening and monitoring of fatigue symptoms, and developing possible prevention and intervention techniques.

Background and Aims

BACKGROUND AND AIMS

A chronic feeling of fatigue occurs in up to 85% of children and adolescents after the completion of their cancer treatment. Chronic fatigue has a detrimental effect on quality of life, reintegration in daily life activities and psychosocial functioning of the patient. Therefore, it is important to define individual risk profiles for chronic fatigue.

Methods

METHODS

Childhood cancer survivors who were treated in the University Hospital of Leuven, completed two annual questionnaires on fear of recurrence, traumatic experience, resilience and fatigue. The associations between cancer-related distress (fear of recurrence and traumatic experience) and fatigue levels were examined by performing two cross-lagged panel analyses. Resilience was included as potential moderator. These models included all within-time associations, stability paths, and cross-lagged paths. Gender and time since diagnosis were included as covariates.

Results

RESULTS

In total, 110 patients participated in this study, aged 16-25 years old (average time since diagnosis 12.2 years; 41.8% boys; diagnosed with leukemia/lymphoma (49%), solid tumor (15%), brain tumor (16%) or other (20%)).

Both fear of recurrence (β=0.167, p=0.042) and traumatic experience (β =0.177, p=0.035) at baseline significantly predicted higher fatigue one year later. The significant interaction effect suggested that resilience could buffer the effect of fear of recurrence on fatigue (β = 0.142, p=0.031). Stability coefficients were high for all study variables.

Girls experienced more fatigue (p<0.001) and fear of recurrence (p=0.004) than boys at baseline, while boys showed more resilience (p<0.001).

Conclusions

CONCLUSIONS

Interventions that can reduce fatigue will only become efficient if we can intervene adequately and instantly at the moment, in the context, according to the needs of the patient. This study suggests that cancer-related distress can exacerbate fatigue. This information should be incorporated in therapeutic interventions.