Group Meaning-Centered Psychotherapy for the Improvement of Wellbeing in Caregivers of Patients With Serious Illness

NCT06630351 | Enrolling By Invitation

• 2 other identifiers: 24-004250NCI-2024-07626
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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 or a serious life-limiting illness. 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 or a serious life-limiting illness.

Conditions

Advanced Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Feasibility of Meaning-Centered Psychotherapy for Caregivers (MCP-C) intervention

  Feasibility will be measured by numbers and percentages of participant recruitment, enrollment, accrual, and retention of participants in the MCP-C intervention. Findings will be summarized using estimates and corresponding 95% confidence intervals.

  Up to 1 year

• Acceptability of MCP-C intervention

  Acceptability will be measured by the Was It Worth It (WIWI) Questionnaire. The WIWI consists of 7 questions, 3 answered with yes/no/uncertain, two answered on a 3-point scale (i.e., improved, stayed the same, or got worse), one open-ended/fill-in-the-blank question, and one yes/no question.

  4 months (2 months post intervention)

Secondary Outcomes (7)

• Change in personal meaning - LAP-R

  Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)

• Change in spiritual well-being - FACIT-Sp-12

  Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)

• Changes in anxiety and depression - HADS

  Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)

• Change in attitude toward caregiving - ATCS

  Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)

• Change in perception of social support - Duke-UNC FSSQ

  Baseline, 8 weeks (post intervention), 4 months (2 months post intervention)

Study Arms (1)

Supportive Care (MCP-C)

EXPERIMENTAL

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.

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

Interventions

Behavioral Counseling BEHAVIORAL

Participate in MCP-C

Also known as: Behavior Counseling, Behavioral Psychotherapy

Supportive Care (MCP-C)

Discussion OTHER

Participate in virtual group discussions

Also known as: Discuss

Supportive Care (MCP-C)

Interview OTHER

Ancillary studies

Supportive Care (MCP-C)

Health Promotion and Education OTHER

Receive reading exercises and workbook materials

Supportive Care (MCP-C)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (MCP-C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• English fluency
• No diagnosed severe cognitive impairment
• Caregiver of a patient with a diagnosis of advanced, solid tumor cancer (stage III/stage IV), caregivers supporting a patient with a serious life-limiting illness
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Behavior Therapy; Health Promotion; Educational Status; Interviews as Topic

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Deirdre R. Pachman, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: October 8, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): September 12, 2026
• Study Completion (Estimated): September 12, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (2)