Clinical trial NCT03454295: Easing Psychosocial Burden for Informal Caregivers
Official title: Improving Palliative Care of Caregivers of Patients With Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Glioblastoma
Keywords: Cancer Caregivers
Caregiver
Caregivers
Memorial Sloan Kettering Cancer Center
18-075
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) delivered to caregivers of participants with GBM
timeFrame: 1 year
measure: Acceptability of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) delivered to caregivers of participants with GBM
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Allison Applebaum, PhD
role: PRINCIPAL_INVESTIGATOR
References: