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

N/AEnrolling By InvitationNCT06630351

Mayo Clinic80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Feasibility of Meaning-Centered Psychotherapy for Caregivers (MCP-C) intervention

Feasibility will be measured by numbers and percentages of participant recruitment, enrollment, accrual, and retention of participants in the MCP-C intervention. Findings will be summarized using estimates and corresponding 95% confidence intervals.

Time frame: Up to 1 year

Acceptability of MCP-C intervention

Acceptability will be measured by the Was It Worth It (WIWI) Questionnaire. The WIWI consists of 7 questions, 3 answered with yes/no/uncertain, two answered on a 3-point scale (i.e., improved, stayed the same, or got worse), one open-ended/fill-in-the-blank question, and one yes/no question.

Time frame: 4 months (2 months post intervention)

Secondary Outcomes

Change in personal meaning - LAP-R

The Life Attitude Profile-Revised (LAP-R) is a 48-item scale that measures a person's life attitude and meaning in life. The LAP-R is scored on a 7-point Likert scale, with a minimum score of 30 and a maximum score of 210. A higher score indicates a greater sense of meaning in life and a more positive attitude towards life.