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Mapping Psychosocial Screening to Services for Children With Cancer

20 октября 2020 г. обновлено: 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

Обзор исследования

Статус

Завершенный

Условия

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

38

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 10 лет до 18 лет (Ребенок, Взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Скрининг
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Без вмешательства: 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).

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Feasibility pertaining to recruitment
Временное ограничение: 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
Временное ограничение: 12 months
Rates of completed questionnaires at all time points
12 months
Satisfaction with Enhanced Intervention as assessed by questionnaire at completion of study
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Distress
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Sleep duration and quality of sleep of patient and caregiver
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

  • Главный следователь: Maru Barrera, PhD, The Hospital for Sick Children

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

27 ноября 2017 г.

Первичное завершение (Действительный)

30 апреля 2020 г.

Завершение исследования (Действительный)

30 апреля 2020 г.

Даты регистрации исследования

Первый отправленный

10 октября 2019 г.

Впервые представлено, что соответствует критериям контроля качества

16 октября 2019 г.

Первый опубликованный (Действительный)

21 октября 2019 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

22 октября 2020 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

20 октября 2020 г.

Последняя проверка

1 октября 2020 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • 1000056445

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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