Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630351
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Group Meaning-Centered Psychotherapy for the Improvement of Wellbeing in Caregivers of Patients with Advanced Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Group Meaning-Centered Psychotherapy for Caregivers of Patients with Advanced Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 20 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 20 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None