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

NCT ID: NCT06630351

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-12
• Study Completion Date: 2026-09-12

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.

Conditions

Advanced Malignant Solid Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care (MCP-C)

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.

Group Type: EXPERIMENTAL

Behavioral Counseling

Intervention Type: BEHAVIORAL

Participate in MCP-C

Discussion

Intervention Type: OTHER

Participate in virtual group discussions

Health Promotion and Education

Intervention Type: OTHER

Receive reading exercises and workbook materials

Interview

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Behavioral Counseling

Participate in MCP-C

Intervention Type: BEHAVIORAL

Discussion

Participate in virtual group discussions

Intervention Type: OTHER

Health Promotion and Education

Receive reading exercises and workbook materials

Intervention Type: OTHER

Interview

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Behavior Counseling; Behavioral Psychotherapy; Discuss

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Deirdre R. Pachman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deirdre R. Pachman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2024-07626

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-004250

Identifier Type: OTHER

Identifier Source: secondary_id

24-004250

Identifier Type: -

Identifier Source: org_study_id