Bright Ideas - CIN Feasibility Study

Официальное название

Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy

Обзор

In this study investigators will determine the feasibility of a future trial comparing chemotherapy-induced nausea control in children with ALL receiving oral 6-mercaptopurine who do and do not receive problem-solving skill training. This is a novel approach to controlling an important and common treatment-related symptom.

Подробное описание

This study will evaluate a novel approach to controlling a treatment-related symptom that detracts significantly from the quality of life of many patients. It will preserve and enhance the patient's and family's autonomy with respect to self-care. If found to be effective, this approach may be generalizable to pediatric patients receiving chemotherapy other than 6-mercaptopurine and thus has the potential to improve the quality of life of many children receiving cancer therapy.

This study will evaluate the efficacy of Bright IDEAS-CIN, adapted from the validated Bright IDEAS framework to improve CIN control in children with ALL who experience nausea while receiving 6-mercaptopurine. Bright IDEAS is an 8-session face-to-face intervention with a caregiver. In this first session, the caregiver is taught the problem-solving framework and begins working on their first self-selected problem. Sessions 2-7 involve working through relevant problems, with most caregivers working through 3-4 different problems. The final session summarizes the skills and discusses how to continue to use these new skills for new problems instead of lapsing into old ineffective strategies. Investigators adapted Bright IDEAS to meet the specific problem of CINV by adapting it to 3 sessions focused specifically on CINV, including the child in the conversation when developmentally appropriate and allowing the latter sessions to be conducted by phone or video-chat.

Вмешательства

• Поведенческое Bright Ideas - CIN Training
  Bright IDEAS is a validated problem-solving skill training intervention.

Первичные конечные точки

• Percent of eligible patients who consent/assent to participate and completion of study procedures by 20 patients within 24 months [Срок оценки: 24 months from study activation]

Вторичные конечные точки (1)

• CIN and CIV incidence [Срок оценки: 24 months from study activation]

Критерии участия

Критерии включения

• Age: ≥ 4 years (PeNAT validated in patients 4 to 18 yrs)
• newly diagnosed or recurrent disease: first diagnosis of ALL (i.e. non-relapsed) in maintenance therapy
• English, French or Spanish-speaking with an English, French or Spanish-speaking guardian (PeNAT available in these languages)
• without physical or cognitive impairments that preclude use of the PeNAT
• planned to receive PO 6-mercaptopurine
• not planned to receive IV, IM, SC or IT chemotherapy or oral or IV corticosteroids during the 7-day study period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Children's Hospital Los Angeles — Los Angeles
• Rutgers Cancer Institute — New Brunswick
• Inova Children's Hospital — Falls Church

Канада · 1 центр

• Hospital for Sick Children — Toronto

Идентификаторы

NCT: NCT04929899 · 1000073003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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