Easing Psychosocial Burden for Informal Caregivers

Improving Palliative Care of Caregivers of Patients With Glioblastoma

The overall goal of this study is to determine the best time to offer Meaning-Centered Psychotherapy (MCP), an intervention that has proven to be helpful in improving spiritual well-being and decreasing existential distress among patients with advanced cancer, to caregivers. (MCP has also been shown to be an appropriate method of attending to the palliative or comfort care needs of caregivers of patients with cancer. Studies show that the psychological burden associated with caring for a patient with advanced cancer is often greater than that experienced by the patients themselves.) The investigators would also like to find out about caregivers initial impressions of MCP-C, Meaning-Centered Psychotherapy for Cancer Caregivers, so that the intervention can be adjusted to meet the unique needs of caregivers of patients with Glioblastoma.

Study Overview

• Status: Completed
• Conditions: Glioblastoma
• Intervention / Treatment: Behavioral: Focus Group; Behavioral: Meaning-Centered Psychotherapy for Cancer Caregivers / MCP-C; Behavioral: Enhanced Usual Care / EUC

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack (Consent only)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (Consent only)
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Part I Focus group GBM informal caregivers (ICs):

• 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
• IC to an MSKCC patient with GBM who died a year or more ago

Part II Randomized Intervention of GBM ICs:

• English-speaking as per English proficiency screener and in the best judgment of the consenting professional
• Current ICs to a patient with GBM
• Age ≥ 18
• Score of > 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role per self-report

Exclusion Criteria:

• In the judgment of the consenting professional, clinician or PI and/or as per medical record, severe psychopathology or cognitive impairment likely to interfere with the participation or completion of the protocol or ability to provide meaningful information
• Another family member of caregiver to the same patients is currently enrolled in the study
• Ultimately, if interested, all caregivers who decline participation or are ineligible for the study for any reason, including because another caregiver of the patient is currently enrolled in the study, will be offered referrals to the MSKCC Counseling Center and to local mental health providers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part I; 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.	Behavioral: Focus Group; 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.
Experimental: Part II; 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.	Behavioral: Meaning-Centered Psychotherapy for Cancer Caregivers / MCP-C; MCP-C is structured as a 7-session (1-hour weekly or biweekly sessions) individual intervention that utilizes a mixture of didactics, discussion and experiential exercises that focus around particular themes related to meaning and cancer caregiving; Behavioral: Enhanced Usual Care / EUC; The "enhancement" to usual care in this study involves the inclusion of screening and targeted referral components as suggested by Reynolds et al. [79]. Research study assistants conducting the screening and providing feedback and referrals will be trained in the NCCN guidelines for distress management and will discuss the screening results and associated recommendations with the study PI (NCCN) [63]. As of November, 2017, ICs of patients seen in the Neurology Service at MSKCC are not consistently screened for distress and offered targeted referrals. Participants randomized to EUC will receive feedback about their level of distress (based on the Distress Thermometer administered at screening) after randomization. Within a week of randomization, and post-baseline, the study RSA will send EUC participants appropriate targeted referrals based on levels of distress and problem areas endorsed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) delivered to caregivers of participants with GBM	Feasibility will be measured by our ability to recruit our target sample of 60 ICs within the 1-year enrollment period. Our feasibility target for completion of follow-up assessments if 80% at T2 and 60% at T3, based on typical assessment completion rates in other psychosocial intervention studies conducted at our institution.	1 year
Acceptability of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) delivered to caregivers of participants with GBM	Acceptability will be informed by the MCP-C completion rate and Phase 2 semi-structured interviews (deemed acceptable if at least 40% complete all psychotherapy sessions).	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Allison Applebaum, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): March 26, 2024
• Study Completion (Actual): March 26, 2024

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Caregiver; Memorial Sloan Kettering Cancer Center; Caregivers; Cancer Caregivers; 18-075
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 18-075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No