Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Mapping Psychosocial Screening to Services for Children With Cancer

20 octobre 2020 mis à jour par: Maru Barrera, The Hospital for Sick Children

Mapping Psychosocial Screening to Services for Children With Cancer: Feasibility and Pilot Study

Children with cancer are vulnerable to symptoms of anxiety and depression. Although screening for psychosocial distress is a standard of care for children with cancer, there is a limited knowledge

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

Background: Approximately 3 000 children and adolescents are diagnosed with cancer in Canada each year [Canadian Cancer Society]. Children with cancer experience higher rates of anxiety and depression symptoms relative to healthy controls [Pinquart & Shen, 2011], and a subgroup are vulnerable to marked levels of psychological distress [Kurtz & Abrams, 2011]. One standard for psychosocial care in pediatric cancer that is starting to be implemented across the United Stated and Canada is the systematic screening for psychosocial distress, using the Psychosocial Assessment Tool (PAT) [Kazak, Schneider, Didonato, Pai, 2015; Pai et al., 2008; Barrera et al., 2014; McCarthy et al., 2009; Sint Nicolaas et al., 2016]. However, a dearth of literature exists on how to bridge screening for psychosocial distress and the delivery of appropriate evidence-based mental health resources. The current study is a randomized controlled pilot intervention project which aims to test the feasibility and effects of introducing a psychosocial navigator who will coordinate the delivery of psychosocial resources to children with cancer and their families based on early screening and follow-up for psychosocial distress. Specific Objectives: 1) To determine the feasibility and utility of conducting psychosocial screening and providing an Enhanced Psychosocial Intervention (EPSI). 2) To examine the effects of EPSI, as compared to treatment as usual (TAU+), on the mental health, quality of life, coping, and social relationships of children with cancer. Methods: A randomized controlled feasibility intervention trial, with a TAU+ control group, will be conducted with newly diagnosed children with any type of cancer. Participants will be 10-18 years of age, medically suitable for participation, in active treatment, and the primary caregiver. Forty-eight child-caregiver dyads (24 in the intervention and 24 in the control group) will be enrolled. The EPSI will have two components: 1) Information about the psychosocial risk of the family and mental health of the child (e.g., depression) and 2) the Psychosocial Navigator (PSN) as resource for tailoring psychosocial resources to child-family distress, linking with the treating team. Measures of feasibility (recruitment, acceptability) will be documented throughout; initial screening using the PAT will be conducted 2-4 weeks post diagnosis (baseline); and using the distress thermometer, follow-up will be done at specific periods depending on the disease (leukemia/lymphoma, solid tumors, brain tumors). The primary psychosocial outcome (depression), and secondary outcomes (post-traumatic stress, pain, fatigue, coping, sleep quality, time and financial cost, social support and quality of life) will be completed at baseline and 12 months later. Descriptive statistics (frequency and percentage rates) will be provided for feasibility measures and PAT psychosocial risk categories. Means, standard deviations, and ranges will be provided for the primary and secondary outcomes. Preliminary analyses of group comparisons will also be performed via independent t tests and chi square tests. Further, analyses of covariance (ANCOVAs) will be conducted on the primary and secondary outcomes to test group differences at post-test while controlling for pretest scores.

Significance: The proposed intervention project will assess and address the psychosocial needs of newly diagnosed pediatric cancer patients and families. This intervention aims to improve the triaging of resources and enhance the effectiveness of psychosocial intervention for children with cancer. The enhanced intervention is expected to improve children's and adolescents' coping with disease-related stressors such as pain and uncertainty, improve their mood, and enhance social engagement with peers.

Type d'étude

Interventionnel

Inscription (Réel)

38

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Ontario
      • Toronto, Ontario, Canada, M4G 3R9
        • Hospital for Sick Children

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

10 ans à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Between 10 and 18 years of age
  • Clinical diagnosis of cancer
  • Less than 4 weeks since diagnosis disclosure
  • Primary caregiver must also consent to participation

Exclusion Criteria:

  • Cancer diagnosis disclosed more than 4 weeks ago.
  • Primary caregiver declines to participate

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Dépistage
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention Group
The Intervention group will receive the services of the Psychosocial Navigator (PSN) monthly for the full 12 months of the study. At baseline, the PSN will provide the health care providers (HCPs) and family with recommendations for mapping and triaging of resources to levels of psychosocial risk (PAT: Universal, Targeted, Clinical) and level of depression and anxiety (mild, moderate, and high mental health problems; as determined by the standardized norms for the measures). This information will be summarized in the Communication Summary Profile and shared with the treating team (oncologist, nurse, and Social Worker, core psychosocial staff involved in the child's care) and family within 48 hours of completion. The PSN will conduct follow-up psychosocial screenings on a monthly basis, using the Distress Thermometer for children and caregivers. Results of the monthly assessments and recommended resources will also be communicated to the caregiver/parent and treating team of the youth.
Services of psychosocial navigator
Both patient/caregiver dyad and HCPs will receive a summary of the PAT results and levels of depression and anxiety.
Aucune intervention: Treatment as Usual Group
Current psychosocial care services will be accessible to Treatment as Usual Group (e.g., social work, child life, psychology, art and music therapy, and psychiatry).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility pertaining to recruitment
Délai: 12 months
Rate of recruitment as measured by percentage of participants who consent to participation as compared to those who are eligible and do not consent
12 months
Feasibility pertaining to retention
Délai: 12 months
Rates of completed questionnaires at all time points
12 months
Satisfaction with Enhanced Intervention as assessed by questionnaire at completion of study
Délai: 12 months
5 - point likert scale satisfaction questionnaire with 6 questions pertaining to usefulness and overall satisfaction with the enhanced intervention. The minimum score is 6 (low satisfaction) and the maximum score is 30 (high satisfaction).
12 months
Satisfaction with Enhanced Intervention as assessed by semi-structured interview at completion of study
Délai: 12 months
Semi-structured interview with 6 questions including "What were your expectations about being in this study?"; "Were your expectations of the study met?"; "Do you have any additional comments/suggestions for the study?"
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Distress
Délai: Change from baseline to 12 months
Pediatric and Adult Distress Thermometer (self-report) measures participant distress on a visual analog scale of 1 to 10, with a score of 10 indicating high distress
Change from baseline to 12 months
Patient generic quality of life based on self report
Délai: Change from baseline to 12 months
Pediatric Quality of Life - generic. (Child/teen self-report). Measures perceived quality of life of child with cancer based on self perception - on everyday items (for children who do not have cancer). Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.
Change from baseline to 12 months
Patient generic quality of life based on caregiver report
Délai: Change from baseline to 12 months
Pediatric Quality of Life - generic. (Caregiver-report). Measures perceived quality of life of child with cancer based on caregiver perception - on everyday items (for children who do not have cancer). Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.
Change from baseline to 12 months
Patient quality of life as it relates to cancer, based on self-report
Délai: Change from baseline to 12 months
Pediatric Quality of Life-Cancer (Child/teen self-report). Measures perceived quality of life of child with cancer based on self-perception. Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.
Change from baseline to 12 months
Patient quality of life as it relates to cancer, based on caregiver report
Délai: Change from baseline to 12 months
Pediatric Quality of Life-Cancer (Caregiver report). Measures perceived quality of life of child with cancer based on caregiver perception. Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.
Change from baseline to 12 months
Patient anxiety and depression - child/teem self report
Délai: Change from baseline to 12 months
Pediatric Index of Emotional Distress. Minimum score is 0. Maximum score is 42. Lower score indicates lower levels of anxiety and depression.
Change from baseline to 12 months
Patient anxiety (child/teen self-report)
Délai: Change from baseline to 12 months
Patient-reported Outcomes Measurement Information System (PROMIS) - pediatric anxiety questionnaire - short form (child/teen self-report). Minimum score is 8. Maximum score is 40. Lower score indicates lower level of anxiety.
Change from baseline to 12 months
Patient depression (child/teen self-report)
Délai: Change from baseline to 12 months
Patient-reported Outcomes Measurement Information System (PROMIS) - pediatric depression questionnaire - short form (child/teen self-report). Minimum score is 8. Maximum score is 40. Lower score indicates lower level of depression.
Change from baseline to 12 months
Caregiver post-traumatic stress related to child's cancer diagnosis
Délai: Change from baseline to 12 months
Impact of Events scale - Revised (IES-R) (caregiver self-report). Mimimum score is 0. Maximum score is 88. Lower scores indicate lower levels of post-traumatic stress.
Change from baseline to 12 months
Patient post-traumatic stress related to own cancer diagnosis
Délai: Change from baseline to 12 months
Impact of Events scale - Revised (IES-R) (child/teen self-report). Mimimum score is 0. Maximum score is 88. Lower scores indicate lower levels of post-traumatic stress.
Change from baseline to 12 months
Caregiver coping with stress of child's cancer diagnosis
Délai: Change from baseline to 12 months
Responses to Stress Questionnaire - Cancer Version (caregiver self-report). Minimum score is 0. Maximum score is 1. A higher score indicates more engagement with active coping strategies.
Change from baseline to 12 months
Patient's own coping with stress of cancer diagnosis
Délai: Change from baseline to 12 months
Response to Stress Questionnaire - Cancer Version (patient self-report). Minimum score is 0. Maximum score is 1. A higher score indicates more engagement with active coping strategies.
Change from baseline to 12 months
Psychosocial risk
Délai: Change from baseline to 12 months
Psychosocial Assessment Tool (PAT) (caregiver report). Minimum score is 0. Maximum score is 3. Lower score indicates lower level of psychosocial risk.
Change from baseline to 12 months
Financial impact of pediatric cancer diagnosis and treatment on families.
Délai: Change from baseline to 12 months
Financial burden questionnaire (caregiver report). Minimum score is 22. Maximum score is 88. Higher score indicates lower level of financial impact on families.
Change from baseline to 12 months
Caregiver depression
Délai: Change from baseline to 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire (caregiver self-report). Minimum score is 6. Maximum score is 30. Lower scores indicate lower levels of depression.
Change from baseline to 12 months
Caregiver anxiety
Délai: Change from baseline to 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire (caregiver self-report). Minimum score is 6. Maximum score is 30. Lower scores indicate lower levels of anxiety.
Change from baseline to 12 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Sleep duration and quality of sleep of patient and caregiver
Délai: Change from baseline to 12 months
Pittsburgh Sleep Quality Index. (Caregiver and patient self-report). Minimum value is 0. Maximum value is 21. Lower scores indicate better sleep quality.
Change from baseline to 12 months
Caregiver emotional support
Délai: Change from baseline to 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support Questionnaire (caregiver self-report). Minimum score is 6. Maximum score is 30. Higher scores indicate higher levels of emotional support.
Change from baseline to 12 months
Caregiver Fatigue
Délai: Change from baseline to 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Questionnaire (caregiver self-report). Minimum score is 6. Maximum score is 30. Lower scores indicate lower levels of fatigue
Change from baseline to 12 months
Patient Peer Relationships
Délai: Change from baseline to 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Perceived Quality of Peer Relationships (child/teen self-report). Minimum score is 8. Maximum score is 40. Higher scores indicate higher levels of perceived peer relationship quality.
Change from baseline to 12 months
Patient Fatigue
Délai: Change from baseline to 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Questionnaire (child/teen self-report). Minimum score is 10. Maximum score is 50. Lower scores indicate lower levels of fatigue.
Change from baseline to 12 months
Patient emotional support
Délai: Change from baseline to 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support Questionnaire (child/teen self-report). Minimum score is 7. Maximum score is 35. Higher scores indicate higher levels of emotional support.
Change from baseline to 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Maru Barrera, PhD, The Hospital for Sick Children

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 novembre 2017

Achèvement primaire (Réel)

30 avril 2020

Achèvement de l'étude (Réel)

30 avril 2020

Dates d'inscription aux études

Première soumission

10 octobre 2019

Première soumission répondant aux critères de contrôle qualité

16 octobre 2019

Première publication (Réel)

21 octobre 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 octobre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 octobre 2020

Dernière vérification

1 octobre 2020

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 1000056445

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner