Group Meaning-Centered Psychotherapy for the Improvement of Wellbeing in Caregivers of Patients With Serious Illness

Официальное название

Group Meaning-Centered Psychotherapy for Caregivers of Patients With Serious Life-Limiting Illness

Обзор

This clinical trial assesses the acceptability and feasibility of a virtual group Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and its effect in improving the wellbeing of caregivers of patients with advanced cancer or a serious life-limiting illness. Caregivers often suffer from significant existential distress, which includes feelings of hopelessness, demoralization, burden, loss of meaning and dignity, and a decreased will to live. MCP-C seeks to help caregivers connect to meaning and purpose despite the challenges of caregiving and helps caregivers understand how sources of meaning may help with symptoms of burden and reduce despair. Participating in MCP-C may help improve sense of personal meaning, spiritual well-being, and mood in caregivers of patients with advanced cancer or a serious life-limiting illness.

Подробное описание

PRIMARY OBJECTIVES:

I. Determine feasibility as measured by total number of caregivers enrolled in 2 years (modification to extend study another year), adherence (75% of the enrolled participants will complete at least 6 of the 8 MCP groups).

II. Determine acceptability as measured by satisfaction with the research process, as measured by the Was It Worth It (WiWi 2.0) questionnaire.

III. To evaluate preliminary efficacy of group MCP-C for personal meaning as measured by Life Attitude Profile-Revised (LAP-R), spiritual wellbeing as measured by Functional Assessment of Chronic Illness Therapy (FACIT) Spiritual Well-Being Scale (SWBS), depression and anxiety symptoms as measured by Hospital Anxiety and Depression Scale (HADS), meaning in caregiving as measured by Attitudes Towards Caregiving Scale (ATCS), social support as measured by Duke-University of North Carolina (UNC) Functional Social Support Questionnaire (FSSQ), benefit finding as measured by Benefit Finding Scale (BFS).

IV. Determine participants' perceptions of their experience with the intervention, including potential benefits they experienced, which components had the greatest impact, and whether they would suggest any changes to the intervention.

OUTLINE:

Caregivers participate in MCP-C virtual group discussion sessions over 90 minutes each and complete reading exercises and workbook assignments once weekly for 8 weeks throughout the study.

After completion of study intervention, caregivers are followed up at 2 months.

Вмешательства

• Поведенческое Behavioral Counseling
  Participate in MCP-C
• Другое Discussion
  Participate in virtual group discussions
• Другое Health Promotion and Education
  Receive reading exercises and workbook materials
• Другое Interview
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Feasibility of Meaning-Centered Psychotherapy for Caregivers (MCP-C) intervention [Срок оценки: Up to 1 year]
• Acceptability of MCP-C intervention [Срок оценки: 4 months (2 months post intervention)]

Вторичные конечные точки (7)

• Change in personal meaning - LAP-R [Срок оценки: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)]
• Change in spiritual well-being - FACIT-Sp-12 [Срок оценки: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)]
• Changes in anxiety and depression - HADS [Срок оценки: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)]
• Change in attitude toward caregiving - ATCS [Срок оценки: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)]
• Change in perception of social support - Duke-UNC FSSQ [Срок оценки: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)]
• Change in benefit-finding - BFS [Срок оценки: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)]
• Change in Cancer Support Source Caregiver-18+ score [Срок оценки: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)]

Критерии участия

Критерии включения

• Age >= 18 years
• English fluency
• No diagnosed severe cognitive impairment
• Caregiver of a patient with a diagnosis of advanced, solid tumor cancer (stage III/stage IV), caregivers supporting a patient with a serious life-limiting illness
• Provide written (paper or electronic) informed consent
• Ability to complete questionnaire(s) by themselves or with assistance
• Patient baseline distress score >= 4/10
• Have ability to utilize the technology to participate in virtual groups

Критерии исключения

• As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded
• Other psychological co-morbidities such as untreated schizophrenia, bipolar disease
• Cognitive impairment likely to interfere with participation

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 · 2 центра

• Mayo Clinic in Florida — Jacksonville
• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT06630351 · 24-004250 · NCI-2024-07626 · 24-004250

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗