Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG

Официальное название

Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin

Обзор

The purpose of this study is to evaluate mood changes in patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical Bacillus Calmete-Guerin (BCG). Patients with Non-Muscle Invasive Bladder Cancer receiving intravesical treatments are eligible to participate in this study. Participation involves providing research blood and urine samples prior to the start of treatment and throughout the treatment course. The study team will also collect participant's medical history and clinical information. Participants will be asked to complete questionnaires and daily mood diaries.

Подробное описание

Patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical treatments are eligible to participate in this study. Participants will be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale prior to each induction intravesical treatment. During the 6-week induction intravesical treatment, participants will also be given a daily mood dairy to complete. Urine Specimens will be collected prior to each induction intravesical treatment and at each 3-month cystoscopy appointment during the treatment course. An at home urine collection may occur 6 hours post intravesical treatment. Research Blood Samples will be collected prior to the first induction intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy as indicated by the participant's treatment course. Participants will be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale prior to each 3-month follow-up cystoscopy during the treatment course. A 3-week daily mood diary will be completed by participants during the 3-week intravesical maintenance treatment. Participants will be given a daily mood diary to complete between the 3-month follow-up cystoscopy appointments.

Вмешательства

• Другое Questionnaires
  Participants will be given the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale to complete prior to each induction intravesical treatment and prior to 3-month follow-up appointments.
• Другое Daily Mood Diaries
  Participants will be given daily mood diaries to complete during their 6-week induction intravesical treatment, 3-week maintenance treatment course, and between 3-month follow-up appointments.
• Другое Urine Specimen Collection
  Urine collections from patients will occur prior to each induction intravesical treatment and at 3-month follow-up cystoscopy appointments. An at home urine collection may occur 6 hours post intravesical treatment.
• Другое Research Blood Draw
  Blood collections will occur prior to first intravesical treatment, prior to fourth intravesical treatment, and each 3-month cystoscopy as indicated by the participant's treatment course.
• Другое Utilize excess tissue from a standard of care procedure
  Participants may indicate permission to provide excess tissue from a clinically indicated procedure for research purposes.

Первичные конечные точки

• Change in cytokine response as assessed by urine samples [Срок оценки: Prior to each 6-week intravesical treatment and every 3-month Cystoscopy for 24 months]
• Change in cytokine response as assessed by blood samples [Срок оценки: Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to the each 3-month follow-up cystoscopy]
• Screening for Mood Disorders utilizing the Zung Self Rating Depression Scale [Срок оценки: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit]

Вторичные конечные точки (3)

• Screening for Mood Disorders utilizing the Zung Self Rating Anxiety Scale [Срок оценки: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit]
• Screening for Mood Disorders utilizing daily mood diaries [Срок оценки: Daily mood diary for 6-week induction intravesical treatment course, daily mood diary for 3-week intravesical treatment maintenance course, and daily mood diary between 3-month follow up cystoscopy appointments]
• Evaluate DNA and RNA-based liquid biopsy biomarkers and correlate them with tissue response [Срок оценки: Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy]

Критерии участия

Критерии включения

• Subjects with a pathologically confirmed non-muscle invasive bladder cancer
• Age ≥ 18 years old
• Ability to understand and willingness to sign a written informed consent document

Критерии исключения

• Patients that are not candidates for intravesical treatment due to the nature of their disease, such as variant histology or progressive disease after a prior course of intravesical treatment.
• Patients who are pregnant

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Sibley Memorial Hospital — Washington D.C.

Идентификаторы

NCT: NCT05672615 · IRB00306420

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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