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Group Meaning-Centered Psychotherapy for the Improvement of Wellbeing in Caregivers of Patients With Advanced Cancer

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Mayo Clinic

Status

Invitation-only

Conditions

Advanced Malignant Solid Neoplasm

Treatments

Other: Interview
Other: Questionnaire Administration
Other: Health Promotion and Education
Behavioral: Behavioral Counseling
Other: Discussion

Study type

Interventional

Funder types

Other

Identifiers

NCT06630351
NCI-2024-07626 (Registry Identifier)
24-004250 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Supportive Care (MCP-C)
Experimental group
Description:
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.
Treatment:
Other: Discussion
Behavioral: Behavioral Counseling
Other: Health Promotion and Education
Other: Questionnaire Administration
Other: Interview

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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