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

Official title

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

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.

Detailed description

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (7)

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗