A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers

Официальное название

Managing Anxiety From Cancer (MAC): Evaluation of a Tailored Anxiety Intervention for Latino Older Adults With Cancer and Their Caregivers

Обзор

The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers.

Вмешательства

• Другое Managing Anxiety from Cancer (MAC)
  The intervention, MAC, is a seven-session (45-60 minutes per session) psychotherapy intervention delivered via videoconference and/or telephone by licensed social workers OR at least a Master's level (or enrolled in a doctorate program) advanced trainees in mental health fields.

Первичные конечные точки

• percentage of participants to complete all study procedures [Срок оценки: 1 year]

Критерии участия

Критерии включения

Older Adults with Cancer (OAC)

• As per medical record or self-report, is currently age 65 years or older
• As per medical record or self-report, currently receiving active cancer treatment OR is within eighteen months of completing active treatment which includes surgery, chemotherapy, radiation, and immunotherapy.
• As per self-report, identifies as Latino and/or Hispanic Ethnicity
• Per self-report, has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) age 40 or older who is willing and able to participate in the study ; if a patient does not have a primary informal caregiver or if the caregiver does not or cannot participate, but meets all other inclusion criteria they will be allowed to enroll in the study
• Scores ≥6 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
• Per self-report, fluent in English and/or Spanish\*\* \*\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:

• How well do you speak English and/or Spanish? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
• What is your preferred language for healthcare? (must respond English and/or Spanish)

Caregiver

• Per OAC report, is primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) for the eligible OAC patient
• As per self-report, is age 40 years or older
• Per self-report, fluent in English and/or Spanish\*\* \*\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study:

• How well do you speak English and/or Spanish? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
• What is your preferred language for healthcare? (must respond English and/or Spanish)

Критерии исключения

OAC

• As per medical record or self-report, currently receiving psychotherapy
• As per medical record or self-report, taking psychotropic medications for < 8 weeks prior to MAC Session 1 and/or anticipates changing their medication during the study
• As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
• Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11
• Per research staff judgment and/or self-report, too ill or weak to complete study procedures
• Per medical record or self-report, receiving hospice care at the time of enrollment

Caregiver

• As per self-report, currently receiving psychotherapy
• As per self-report, taking psychotropic medications for < 8 weeks prior to MAC Session 1 and/or anticipates changing their medication during the study
• As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
• Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 11
• Per research staff judgment and/or self-report, too ill or weak to complete study procedures

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 7 центров

• Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
• Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
• Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
• Memorial Sloan Kettering Cancer Center (All protocol activities) — New York
• Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre

Идентификаторы

NCT: NCT06305741 · 24-060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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