Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06630351
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-14
First Post:
2024-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Group Meaning-Centered Psychotherapy for the Improvement of Wellbeing in Caregivers of Patients With Advanced Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Group Meaning-Centered Psychotherapy for Caregivers of Patients With Advanced Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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. 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine feasibility as measured by total number of caregivers enrolled in 1 year, adherence.
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.
I. Determine feasibility as measured by total number of caregivers enrolled in 1 year, adherence.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: