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Meaning-Centered Psychotherapy for Caregivers' Stress

Phase < 1

Waitlist Available

Led By Allison Applebaum, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English-speaking as English proficiency screener and in the best judgment of the consenting professional. This is due to the focus groups being managed in English and the use of certain validated questionnaires only being available in English.

Age > 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an intervention called Meaning-Centered Psychotherapy (MCP) to see if it can improve spiritual well-being and decrease existential distress in caregivers of patients with Glioblastoma. The investigators want to find out about caregivers' initial impressions of MCP so that the intervention can be adjusted to better meet their needs.

Who is the study for?

This trial is for adults over 18 who are informal caregivers to patients with Glioblastoma. They must feel distressed, linking it to their caregiving role, and be able to speak English fluently due to the nature of the focus groups and questionnaires.

What is being tested?

The study tests when it's best to offer Meaning-Centered Psychotherapy (MCP) for cancer caregivers. It compares MCP's impact on spiritual well-being and existential distress against Enhanced Usual Care in a focus group setting.

What are the potential side effects?

Since this trial involves psychotherapy rather than medication, traditional side effects aren't expected. Participants may experience emotional discomfort discussing personal experiences during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am proficient in English.

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I am older than 18 years.

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I am a close contact of an MSKCC patient with GBM who passed away over a year ago.

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I am currently providing informed consent for a glioblastoma trial.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) delivered to caregivers of participants with GBM

Glioblastoma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part IIExperimental Treatment2 Interventions

In Part 2, we will recruit 60 ICs of patients with GBM who will be randomized to receive either MCP-C or EUC. MCP-C will be delivered individually over 7 1-hour-long sessions within 7 - 14 weeks.

Group II: Part IExperimental Treatment1 Intervention

Focus group (Part 1) of four to ten GBM ICs bereaved at least one year to help determine our recruitment strategy. Participants will be asked to reflect on their caregiving experience and specifically, when the receipt of a supportive intervention that addresses existential distress would have been most appropriate and well received. Should consensus among participants be reached (e.g., if the majority report that being approached at time of their loved one's cancer recurrence would have been the optimal time for enrollment), we will target our enrollment timeline to this point (and this timeline will be reflected in amended inclusion criteria). If no consensus is reached, the study staff will enroll ICs at all points in the caregiving trajectory and revisit the appropriateness of various points of contact during the Part 2 individual interviews.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enhanced Usual Care / EUC

2018

Completed Early Phase 1

~70

Focus Group

2017

Completed Phase 1

~4710