Clinical trial NCT06630351: Group Meaning-Centered Psychotherapy for the Improvement of Wellbeing in Caregivers of Patients with Advanced Cancer
Official title: Group Meaning-Centered Psychotherapy for Caregivers of Patients with Advanced Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Advanced Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility of Meaning-Centered Psychotherapy for Caregivers (MCP-C) intervention
timeFrame: Up to 1 year
measure: Acceptability of MCP-C intervention
timeFrame: 4 months (2 months post intervention)
Secondary outcomes:
measure: Change in personal meaning - LAP-R
timeFrame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
measure: Change in spiritual well-being - FACIT-Sp-12
timeFrame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
measure: Changes in anxiety and depression - HADS
timeFrame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
measure: Change in attitude toward caregiving - ATCS
timeFrame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
measure: Change in perception of social support - Duke-UNC FSSQ
timeFrame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
measure: Change in benefit-finding - BFS
timeFrame: Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Deirdre R. Pachman, MD
role: PRINCIPAL_INVESTIGATOR
References: