To hear about similar clinical trials, please enter your email below
Trial Title:
Group Meaning-Centered Psychotherapy for the Improvement of Wellbeing in Caregivers of Patients with Advanced Cancer
NCT ID:
NCT06630351
Condition:
Advanced Malignant Solid Neoplasm
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Behavioral Counseling
Description:
Participate in MCP-C
Arm group label:
Supportive Care (MCP-C)
Other name:
Behavior Counseling
Other name:
Behavioral Psychotherapy
Intervention type:
Other
Intervention name:
Discussion
Description:
Participate in virtual group discussions
Arm group label:
Supportive Care (MCP-C)
Other name:
Discuss
Intervention type:
Other
Intervention name:
Health Promotion and Education
Description:
Receive reading exercises and workbook materials
Arm group label:
Supportive Care (MCP-C)
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Supportive Care (MCP-C)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Supportive Care (MCP-C)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age >= 18 years
- English fluency
- No diagnosed severe cognitive impairment
- Caregiver of a patient with diagnosis of advanced, solid tumor cancer (stage
III/stage IV)
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Start date:
September 12, 2024
Completion date:
September 12, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06630351
https://www.mayo.edu/research/clinical-trials
