Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Mapping Psychosocial Screening to Services for Children With Cancer

20. Oktober 2020 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

38

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

10 Jahre bis 18 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Screening
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Kein Eingriff: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility pertaining to recruitment
Zeitfenster: 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
Zeitfenster: 12 months
Rates of completed questionnaires at all time points
12 months
Satisfaction with Enhanced Intervention as assessed by questionnaire at completion of study
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Distress
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sleep duration and quality of sleep of patient and caregiver
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Maru Barrera, PhD, The Hospital for Sick Children

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. November 2017

Primärer Abschluss (Tatsächlich)

30. April 2020

Studienabschluss (Tatsächlich)

30. April 2020

Studienanmeldedaten

Zuerst eingereicht

10. Oktober 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Oktober 2019

Zuerst gepostet (Tatsächlich)

21. Oktober 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Oktober 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Oktober 2020

Zuletzt verifiziert

1. Oktober 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 1000056445

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Psychosocial Navigator

Abonnieren