NCT03454295.

Trial name or title	Improving palliative care of caregivers of patients with glioblastoma
Methods	Randomised controlled trial
Participants	Inclusion criteria Phase I: focus group with GBM caregivers 1. English‐speaking, due to the focus groups being managed in English and the use of certain validated questionnaires only being available in English; 2. aged > 18 years; 3. caregiver to patient with GBM who died ≥ 1 year ago. Phase II: randomised intervention of GBM caregivers 1. English‐speaking; 2. current caregiver to a patient with GBM; 3. aged > 18 years; 4. score > 4 on the Distress Thermometer and indication that this distress is related in some way to the caregiving role per self‐report. Exclusion criteria 1. In the judgement of the consenting professional, clinician or principal investigator, 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; 2. another family member or caregiver to the same patient is currently enrolled in the study.
Interventions	Intervention: MCP‐C. MCP‐C is based on the principles of Viktor Frankl’s Logotherapy. It is designed to help caregivers of patients with advanced cancer sustain or enhance a sense of meaning, peace, and purpose in their lives. MCP‐C is structured as a 7‐session (1‐hour weekly or biweekly sessions) individual intervention that utilises a mixture of didactics, discussion, and experiential exercises that focus around particular themes related to meaning and cancer caregiving. Control: enhanced usual care. The 'enhancement' to usual care in this study involves the inclusion of screening and targeted referral components. Research study assistants conducting the screening and providing feedback and referrals will be trained in the National Comprehensive Cancer Network guidelines for distress management and will discuss the screening results and associated recommendations with the study principal investigator.
Outcomes	Aim 1: determine the feasibility, acceptability, and preliminary effects of MCP‐C delivered to caregivers of patients with GBM. Aim 2: to customise the content and format of the MCP‐C to address the unique existential and psychosocial needs of caregivers of patients with GBM
Starting date	12 February 2018
Contact information	ApplebaA@mskcc.org
Notes	Confirmed as accurate 21 January 2019. Phase I is completed, phase II has thus far recruited 10 caregivers.