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Идёт набор NCT07091032

Building Connections

Без фазы С лечением Cancer Colorectal Cancer Cervix Depression, Anxiety Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Treatment as Usual, Building Connections Intervention.
Кому может быть актуально
Состояния в реестре: Cancer Colorectal, Cancer Cervix, Depression, Anxiety, Obesity. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Building Connections Between Practices, Patients, and Community Health

Обзор

Building Connections seeks to address health and healthcare inequities in socially vulnerable communities. The project will be conducted in collaboration with clinical practices across Massachusetts, serving a diverse population heavily represented in Community Clinics and Health Centers. The program will offer evidence-based interventions in obesity/weight management, cancer screening, and mental health.

Вмешательства

  • Другое Treatment as Usual
    This is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic.
  • Поведенческое Building Connections Intervention
    The combined Building Connections intervention incorporates three areas. Participants take part in those for which they are eligible. The obesity/weight management intervention offers coaching and support for education on evidence-based anti-obesity medications (AOM) and a lifestyle behavioral intervention offered by Community Health Workers focused on diet and physical activity. The cancer screening intervention focuses on developing workflows and systems to offer a CHW-delivered population-bas

Первичные конечные точки

  • Self-reported height/weight for Body Mass Index (BMI) [Срок оценки: Baseline, month 6, and month 12]
  • Rate of cancer screening test completion [Срок оценки: Baseline, month 6, month 12]
  • Computerized Adaptive Testing (CAT) of Mental Health (MH) [Срок оценки: Baseline, month 6, month 12]
Вторичные конечные точки (3)
  • Rapid Prime Diet Quality Score Screener (rPDQS) [Срок оценки: Baseline, month 6, month 12]
  • Cancer screening test type [Срок оценки: Baseline, month 6, month 12]
  • World Health Organization Disability Assessment Schedule (WHODAS) 2.0 [Срок оценки: Baseline, month 6, month 12]

Критерии участия

Критерии включения

  • The general inclusion criteria involve being 18+, speaking English or Spanish, and meeting one or more of the following criteria:

Obesity: Patients with a body mass index of 30 kg/m2 or greater (i.e., obese category).

Cancer screening: Average-risk patients without recommended colorectal or cervical cancer screenings for their age group and biological sex. Specifically:

Colon Cancer (CRC) inclusion criteria: Patients aged 45-75 who are due for screenings, with last FIT longer than 1 year ago, last colonoscopy longer than 10 years ago, and last Cologuard longer than 3 years ago.

And/or

Cervical cancer inclusion criteria: Women and patients with a cervix aged 30-65 who are due for screening: with last pap longer than 3 years ago; last co-test longer than 5 years ago; last primary HPV screening longer than 5 years ago.

Mental health: Patients with moderate to severe depression or anxiety symptoms.

Критерии исключения

  • The general exclusion criteria are: those with current pregnancy, or the participant is cognitively impaired, not having a visit to the primary care clinic in the prior 2 years, and speaking a language other than English or Spanish.

Exclusion criteria for obesity intervention: had prior metabolic or bariatric surgery or planning to have this surgery in the next 6 months, currently enrolled in an intensive lifestyle program.

Exclusion criteria for cancer screening intervention include:

Colon Cancer (CRC) exclusion criteria: has colorectal cancer documented in the problem list; has ulcerative colitis or Crohn's disease documented in the problem list

Cervical cancer exclusion criteria: has cervical cancer documented in the problem list; has had a prior hysterectomy.

Exclusion criteria for mental health: include patients with active suicidality, active substance use disorder, a history of schizophrenia or bipolar disorder, or who are already receiving behavioral health care (therapy sessions in the past 3 months or an appointment upcoming in the next month).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Disparities Research Unit, Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07091032 · 2025P000661

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗