Cancer and Mild Cognitive Impairment Dyadic Intervention

Официальное название

A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment-2

Обзор

The purpose of this study is to see whether programs that include both a patient and their spouse or a patient and family caregiver (known as a dyad) are helpful for families in which one member of the dyad has cancer and mild memory difficulties and/or concerns. Participant and their spouse or participant and their family caregiver will have six, 60-minute video-conference sessions which will be scheduled at their convenience. The investigator will loan participants a tablet computer (iPad) to use for videoconferencing and train the participant in its use. Participant and their spouse or participant and their family caregiver will complete three assessments - one before starting the sessions, one after the sixth session, and one after 1 month. Each assessment will include surveys, which the participant will complete separately from their spouse or family caregiver. For most people, it will take upwards of 2 - 4 months to complete this study

Вмешательства

• Поведенческое Behavioral: COPE +
  Six sixty minute sessions that teaches participants distress and communication coping skills.

Первичные конечные точки

• Number of completed sessions as measured by enrollment log [Срок оценки: Up to 17 Weeks]
• Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8 [Срок оценки: Up to 17 weeks]

Вторичные конечные точки (4)

• Change in Distress as measured by the DASS-21 [Срок оценки: Baseline, up to 17 weeks, up to 1 month follow up]
• Change in Quality of Life as measured by the FACT-G [Срок оценки: Baseline, up to 17 weeks, up to 1 month follow up]
• Change in Communication Patterns as measured by the CPQ-SF [Срок оценки: Baseline, up to 17 weeks, up to 1 month follow up]
• Change in Relationship Satisfaction as measured by the Mutuality Scale of the Family Care Inventory [Срок оценки: Baseline, up to 17 weeks, up to 1 month follow up]

Критерии участия

Критерии включения

Patient inclusion criteria include:

• Patients with Stage I-IV breast, gastrointestinal (GI), genitourinary (GU), or lung cancer (including extensive stage small cell lung cancer), diagnosed within two years; age 65 or older.
• Participants must be living at home (either in her/his own home).
• Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
• Exhibit Mild Cognitive Impairment/Concerns
• Have an informal family caregiver.

Критерии включения

(Partner or family member) inclusion criteria include:

• Caregivers are 18 older.
• Be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
• Either co-reside with the patient or spend at least 3-4 hours day caregiving.
• Not exhibit cognitive impairment.

Критерии исключения

• Participant has visual or hearing impairments that preclude participation.
• Participant has dementia and do not have the capacity to participate.
• Have a serious untreated psychiatric illness as documented in medical chart review.
• The patient and the caregiver score less than a 3 on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) on a scale 0 to 10 to screen for distress. At least one dyad member must experience distress.

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 · 1 центр

• Duke University — Durham

Идентификаторы

NCT: NCT05144516 · Pro00109148

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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